Overweight and ObesityPhase 1/2CONTEMPONCT06151964
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
A Phase 1/2 study testing AZD9550 and AZD9550 and AZD6234 in people with Overweight and Obesity, run by AstraZeneca at 15 sites in 5 countries.
Trial summary
AZD9550, previously being developed for the treatment NASH, is a dual GCG and GLP-1 receptor agonist. AZD9550 is now being developed in combination with AZD6234, a SARA, for the treatment of overweight and obesity and its associated co-morbidities. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- AZD9550 and AZD9550 and AZD6234
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 29 Sep 2023to 29 Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18 through 65 years (Parts A-D) or 75 years (Part E-F) at the time of screening.
- Parts A, B, C only: Participants with or without T2DM. If participants have a diagnosis of T2DM, the glucose control managed with diabetes diet and in addition to metformin treatment no more than two treatment options (with a stable dose 3 months prior to screening).
- Part D only: Participants who are diagnosed with T2DM, have inadequate glycaemic control with diet and exercise. Participants who are prescribed an oral anti-diabetic agent such as metformin, a DPP IV inhibitor, sulphonylurea, glinides, alphaglucosidase inhibitors, and an SGLT2 inhibitor may be eligible to enter the study following a washout of 4-weeks or 5-half lives (whichever is longer) washout period.
- Part E only: Participants are eligible to be included in the Part E only if they meet all of the following criteria at screening:
- Diagnosed with T2DM.
- Are treated with diet and exercise only, or any combination of OAD with stable doses in the 3 months prior to dosing.
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- Participants prescribed a DPP IV inhibitor or a GLP-1RA-containing medicine, alone or in combination with other OADs, may be eligible to enter the study if they have not been treated with any of these drugs for at least 35 days or 5 drug half-lives (whichever is longer) prior to randomisation.
- Participants with a screening HbA1c value within the target range of
- Parts A to E:≥ 42 to ≤ 86 mmol/mol (6% to 10%).
- Part F: < 48 mmol/mol (6.5%).
- Body mass index from ≥ 27 to ≤ 39.9 kg/m2 (inclusive) (Part A-C) or ≥ 27 kg/m2 (Part E), or ≥ 30 kg/m2 (Part F).
- Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Written informed consent and any locally required authorization (eg, European Union Data Privacy Directive) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations
- Ability to complete and meet all eligibility requirements for randomisation within 60 days after signing the ICF.
- Venous access suitable for multiple cannulations.
- Willing and able to "route of administration" weekly SC injections (Parts C, D, E, and F only).
Who cannot join
- Participants with T2DM (Part F) and participants with T2DM treated with insulin (Parts A-E).
- Participants with T2DM treated with more than 3 anti-diabetic therapies (Parts A-D only).
- Treatment with GLP-1RA or GLP-1RA/GIPRA within 3 months of screening (Parts A to C only) or within 35 days of randomisation or five half-lives (whichever is shorter) of dosing (Parts E and F only).
- History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- Serum calcitonin suggestive of thyroid C-cell hyperplasia (calcitonin level > 50 ng/L), medullary thyroid carcinoma, or history or family history of multiple endocrine neoplasia at screening.
- History or presence of GI, renal, or hepatic disease (with the exception of Gilbert's syndrome), or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs, as judged by the investigator.
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- History of cancer within the last 10 years, with the exception of non-melanoma skin cancer.
- Any clinically important illness (apart from T2DM), as judged by the investigator.
- Any medical/surgical procedure, or trauma within 4 weeks prior to screening, at the discretion of the investigator.
- Symptoms of insulinopenia or poor blood glucose control (eg, significant thirst, nocturia, polyuria, polydipsia, or weight loss).
- Positive hepatitis B or hepatitis C virus serology at screening.
- Positive human immunodeficiency virus test at screening or participant taking antiretroviral medications as determined by medical history or participant's verbal report.
- At screening blood tests, any of the following:
- AST ≥ 1.5 × ULN
- ALT ≥ 1.5 × ULN
- TBL ≥ 1.5 × ULN (with the exception of Gilbert's syndrome)
- Haemoglobin below the lower limit of the normal range or any other clinically significant haematological abnormality as judged by the investigator.
- Total serum calcium, albumin-corrected calcium or ionised calcium < LLN at screening (Part E).
- Impaired renal function defined as eGFR ≤ 60 mL/minute/1.73 m2 as defined by Chronic Kidney Disease Epidemiology Collaboration (2021) (Part A to C); or ≤ 45 mL/minute/1.73 m2 (Parts E and F).
- Any clinically important abnormalities in clinical chemistry, haematology, coagulation, or urinalysis results other than those specifically described as exclusion criteria herein, as judged by the investigator.
- Significant late diabetic complications (macroangiopathy with symptoms of congestive heart disease or peripheral arterial disease, microangiopathy with symptoms of neuropathy, gastroparesis, retinopathy requiring treatment, nephropathy) detected in laboratory results or in clinical history/documentation as judged by the investigator.
- Abnormal vital signs, after 10 minutes of supine rest, defined as any of the following:
- Systolic BP < 90 mmHg or ≥ 150 mmHg
- Diastolic BP < 50 mmHg or ≥ 90 mmHg
- HR < 50 or > 85 bpm at resting state
- Participants may be re-tested for the vital signs criteria only once if, in the investigator's judgement, they are not representative of the participant.
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, as considered by the investigator, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.
- Participants with implantable cardiac defibrillator or a permanent pacemaker, and participants with symptomatic tachy- or brady-arrhythmias.
- Participants with unstable angina pectoris or stable angina pectoris classified higher than Canadian Cardiovascular Society class II or an acute coronary syndrome/acute myocardial infarction or coronary intervention with percutaneous coronary intervention or coronary artery bypass grafting or stroke within 6 months.
- In Parts A-D: History of hospitalisation caused by heart failure or a diagnosis of heart failure. In Part E, severe congestive heart failure (New York Heart Association Class III or IV) or recent (< 6 months) hospitalisation due to heart failure.
- Known or suspected history of drug abuse within the past 3 years as judged by the investigator (Parts A-F) and/or a positive screen for drugs of abuse at screening (Parts A-C only).
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity as judged by the investigator.
- Whole blood or red blood cell donation, or any blood loss > 500 mL (or > 400 mL in Part D) during the 3 months prior to screening.
- History of psychosis or bipolar disorder.
- History of major depressive disorder within the 2 years prior to screening or depression, where the participant is deemed to be clinically unstable as judged by the investigator.
- Previous hospitalisation for any psychiatric reason.
- Questionnaire score ≥ xx within the x years prior to screening or at screening (Parts E and F only).
- Received another new chemical entity (defined as a compound that has not been approved for marketing), or has participated in any other clinical study that included drug treatment within at least 30 days or 5 half-lives prior to the first administration of study intervention in this study (whichever is longer). The period of exclusion to begin 30 days or 5 halflives of IMP after the final dose, or after the last visit, whichever is longest. Participants consented and screened, but not randomised into this study or a previous Phase 1 study, are not excluded.
- History of lactic acidosis
- Use of any of the following medicinal products:
- Use of systemic corticosteroids within 28 days prior to screening.
- Use of compounds known to prolong the QTc interval.
- Use of any herbal preparations or medicinal products licensed for control of body weight or appetite within 3 months prior to screening.
- Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of study intervention.
- Received another new chemical entity (defined as a compound that has not been approved for marketing), or has participated in any other clinical study that included drug treatment within at least 30 days or 5 half-lives prior to the first administration of study intervention in this study (whichever is longer). The period of exclusion to begin 30 days or 5 half-lives of IMP after the final dose, or after the last visit, whichever is longest. Participants consented and screened, but not randomised into this study or previous AZD9550, AZD6234, or AZD9550/AZD6234 combination studies, are not excluded from Part E.
- Previous enrolment or randomisation in the present study.
- Concurrent participation in another study of any kind is prohibited.
- Ongoing weight loss diet (hypocaloric diet) or use of weight loss agents, unless the diet or treatment has been stopped at least 3 months prior to screening and the participant has had a stable body weight (± 5%) during the 3 months prior to screening.
- Participants who are vegans, ones with medical dietary restrictions, or participants who are willingly conducting any diet likely to increase ketone levels (Atkins or any similar diet based on increased protein consummation or low carbohydrate content) (Part A-D only).
- Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, Coca-Cola/Pepsi or similar drink type, chocolate) as judged by the investigator (Part A-D only).
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 3 months prior to screening (Part A-D only).
- Participants who cannot communicate reliably with the investigator or vulnerable participants (eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order).
- The participant is an employee, or close relative of an employee, of AstraZeneca, the Service Provider, or the study site, regardless of the employee's role.
- Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- Contra-indication to MRI: such as participants with pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or other conditions that would preclude proximity to a strong magnetic field; participants with history of extreme claustrophobia or participant cannot fit inside the MRI scanner cavity (Parts B and C only).
- Serum triglyceride concentrations > 500 mg/dL (5.6 mmol/L) at screening or any other metabolic condition judged by the investigator as likely to precipitate acute pancreatitis (Part E only).
- History of use of marijuana or THC-containing products within 3 months prior to screening or unwillingness to abstain from marijuana or THC-containing products use during the study (Parts E and F only).
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Canada6 sites
Research Site
Hamilton, Ontario, L8L 5G8
Research Site
Sarnia, Ontario, N7T 4X3
Research Site
Sherbrooke, Quebec, J1L 0H8
Research Site
Stouffville, Ontario, L4A 1H2
Research Site
Surrey, British Columbia, V3T 4G8
Research Site
Toronto, Ontario, M4G 3E8
Germany3 sites
Research Site
Magdeburg, 39120
Research Site
Neu-Ulm, 89231
Research Site
Neuss, 41460
Japan3 sites
Research Site
Fukuoka, 812-0025
Research Site
Shinjuku-ku, 160-0004
Research Site
Suita-shi, 565-0853
About this study
Official title: A Phase I/II, Randomised, Single-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD9550 Monotherapy and Co-administration of AZD9550 and AZD6234 in Participants Living With Obesity and Overweight With or Without Type 2 Diabetes Mellitus
AZD9550, previously being developed for the treatment NASH, is a dual GCG and GLP-1 receptor agonist. AZD9550 is now being developed in combination with AZD6234, a SARA, for the treatment of overweight and obesity and its associated co-morbidities. Co-administration of AZD9550 and AZD6234 is currently being evaluated in participants living with obesity and overweight without T2DM in an ongoing Phase 2b study.
The purpose of this study is to investigate the safety, tolerability, and effects of increasing doses of AZD9550 monotherapy in overweight and obese participants aged 18 through 65 years living with or without T2DM, and to investigate how AZD9550 is absorbed, distributed, and eliminated from the body (Parts A-D).
In addition, the study will investigate the safety and tolerability of co-administration of AZD9550 and AZD6234 in participants living with T2DM with obesity or overweight aged 18 through 75 years (Part E), and safety and tolerability for different titration regimens for AZD9550 in participants living with obesity, but without T2DM, aged 18 through 75 years (Part F).
Read the detailed description
This Phase I/II, randomised, single-blind, placebo-controlled, MAD study will assess the safety and tolerability of AZD9550 monotherapy and co-administration of AZD9550 and AZD6234 and will characterise the PK and PD of AZD9550 monotherapy and co-administration of AZD9550 and AZD6234 following SC administration to overweight and obese participants living with or without T2DM. Inclusion of participants receiving placebo is appropriate for benchmarking the safety and tolerability of AZD9550 and co-administration of AZD9550 and AZD6234. A randomised and single-blind study design has been chosen to minimise bias and includes a placebo to facilitate identification of effects related to the administration of the study intervention rather than the study procedures or situation.
- Conditions
- Overweight and Obesity
- Being tested
- AZD9550, placebo, AZD9550 and AZD6234
- Keywords
- AZD9550, AZD6234, Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, Overweight, Obese, Obesity, Diabetes Mellitus, Type 2, Liver Glycogen, Adipose Tissue, Glucose, 3-Hydroxybutyric Acid, Subcutaneous Fat, Liver fat, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, Weight Loss, Mixed Meal Tolerance Test
- Medical subject headings
- Overweight, Obesity, Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2, Fatty Liver, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9550Drug
Part A: A constant dose Part B: Doses of AZD9550 that increase each week Part C: Doses of AZD9550 that increase every 2 weeks, then every 4 weeks Part D: Doses of AZD9550 that increase every 2 weeks, then every 4 weeks Part F: Doses of AZD9550 that increase every 4 weeks or every 2 weeks and then every 4 weeks
placeboDrug
Matching administration volumes for SC injection.
For Part E placebo two injections of two different placebos.
AZD9550 and AZD6234Drug
Part E: Doses of AZD9550 and AZD6234 that increase every 2 weeks, then every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Part A: AZD9550 | Experimental | Multiple repeat doses of AZD9550 given as 4 once weekly SC doses for 4 weeks to 2 sequential cohorts in overweight/obese participants with or without T2DM, evaluating 2 low dose levels of AZD9550 Receives: Drug: AZD9550 |
| Part B: AZD9550 | Experimental | Once weekly up-titration over 5 doses of AZD9550 in overweight/obese participants with or without T2DM Receives: Drug: AZD9550 |
| Part C: AZD9550 | Experimental | Bi-weekly/monthly up-titration of AZD9550 for 24 weeks in overweight/obese participants with or without T2DM. Receives: Drug: AZD9550 |
| Part D: AZD9550 | Experimental | Bi-weekly/monthly up-titration of AZD9550 for 24 weeks in overweight/obese Japanese participants with T2DM. Receives: Drug: AZD9550 |
| Part A: placebo | Experimental | Multiple repeat doses of placebo given as 4 once weekly SC doses for 4 weeks to 2 sequential cohorts in overweight/obese participants with or without T2DM, evaluating 2 low dose levels of AZD9550 Receives: Drug: placebo |
| Part B: placebo | Experimental | Once weekly administration of placebo over 5 doses, volume matched to the active treatment being up-titrated, in overweight/obese participants with or without T2DM Receives: Drug: placebo |
| Part C: placebo | Experimental | Bi-weekly/monthly administration of placebo - volume matched to the active treatment being up-titrated - for 24 weeks in overweight/obese participants with or without T2DM. Receives: Drug: placebo |
| Part D: placebo | Experimental | Bi-weekly/monthly administration of placebo - volume matched to the active treatment being up-titrated - 24 weeks in overweight/obese Japanese participants with T2DM. Receives: Drug: placebo |
| Part E: AZD9550 and AZD6234 | Experimental | Bi-weekly/monthly up-titration of AZD9550 and AZD6234 for 24 weeks in overweight/obese participants with T2DM. Receives: Drug: AZD9550 and AZD6234 |
| Part E: placebo | Experimental | Bi-weekly/monthly administration of placebo - volume matched to the active treatments being up-titrated - 24 weeks in overweight/obese participants with T2DM. Receives: Drug: placebo |
| Part F: AZD9550 | Experimental | Bi-weekly/monthly up-titration of AZD9550 for 28 weeks in obese participants without T2DM. Receives: Drug: AZD9550 |
| Part F: placebo | Experimental | Bi-weekly/monthly administration of placebo - volume matched to the active treatment - 28 weeks in obese participants without T2DM. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants with any AE, SAEs, AEs leading to discontinuation of study intervention, AEs with outcome of death, and AEs leading to withdrawal from study.
Applicable for Parts A, B, C, D, E, F.
Measured: Day - 35 to Day 261
Number and percentage of participants with clinically significant changes from baseline in Vital Sign Parameters.
Applicable for Parts A, B, C, D, E, F.
Measured: Day - 35 to Day 261
Number and percentage of participants with clinically significant changes in ECG parameters.
Applicable for Parts A, B, C, D, E, F.
Measured: Day - 35 to Day 261
Number and percentage of participants with clinically significant changes from baseline in Clinical Laboratory Parameters
Applicable for Parts A, B, C, D, E, F.
Measured: Day - 35 to Day 261
Area Under Concentration-Time Curve of AZD9550 following repeat weekly SC doses
- AUC from 0 to the time of the last measured concentration (AUClast) at first dose and last dose
- AUC over a dosing interval (AUCtau) at first dose and last dose.
Applicable for Part A.
Measured: Day 1 to Day 65
Maximum observed concentration of AZD9550 following repeat weekly SC doses
- Cmax at first dose and last dose
Applicable for Part A.
Measured: Day 1 to Day 65
Half life associated with terminal phase elimination rate constant of AZD9550 following repeat weekly SC doses
- t1/2λz at first dose and last dose
Applicable for Part A.
Measured: Day 1 to Day 65
Time to maximum observed concentration of AZD9550 following repeat weekly SC doses
- tmax at first dose and last dose
Applicable for Part A.
Measured: Day 1 to Day 65
Apparent oral clearance of AZD9550 following repeat weekly SC doses
- CL/F at first dose and last dose
Applicable for Part A.
Measured: Day 1 to Day 65
Apparent volume of distribution of AZD9550 following repeat weekly SC doses
- Vz/F at first dose and last dose
Applicable for Part A.
Measured: Day 1 to Day 65
Ratio for AUC of AZD9550 following repeat weekly SC doses
- Rac AUCtau at last dose
Applicable for Part A.
Measured: Day 1 to Day 65
Ratio for Cmax of AZD9550 following repeat weekly SC doses
- Rac Cmax at last dose
Applicable for Part A.
Measured: Day 1 to Day 65
Secondary outcomes (75)
PD effect of AZD9550 on fasting glucose compared to placebo
- Absolute change in fasting glucose
Applicable for Part A.
Measured: From baseline to Week 4
PD effect of AZD9550 on fasting lipid profile compared to placebo
- Absolute and percentage change in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides, and BHB
Applicable for Part A.
Measured: From baseline to Week 4
Absolute and percentage change in body weight from baseline
Applicable for Part A.
Measured: From baseline to Week 4
Incidence of anti-AZD9550 antibodies
- Incidence of ADA to AZD9550
Applicable for Part A.
Measured: From Day 1 to Day 65
Absolute change in percentage body fat from baseline
Applicable for Part A.
Measured: From baseline to Week 4
PD effect of AZD9550 on fasting glucose compared to placebo
- Absolute change in fasting glucose
Applicable for Part B.
Measured: From baseline to Week 5
PD effect of AZD9550 on fasting lipid profile compared to placebo
- Absolute and percentage change in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglyceride, and BHB
Applicable for Part B.
Measured: From baseline to Week 5
Effect of AZD9550 on hepatic fat fraction versus placebo at Week 5
- Change in hepatic fat fraction as measured by MRI-PDFF
- Percent change in hepatic fat fraction as measured by MRI-PDFF
Applicable for Part B.
Measured: From baseline to Week 5
PD effect of AZD9550 on glucose metabolism following an MMTT compared to placebo
- Percent change in glucose AUC(0-4h) measured by MMTT
- Percent change in insulin AUC(0-4h) measured by MMTT
- Percent change in c-peptide AUC(0-4h) measured by MMTT
Applicable for Part B.
Measured: From baseline to Week 5
Area Under concentration-time Curve of AZD9550 following repeat weekly SC doses
- AUC from 0 to the time of the last measured concentration (AUClast) at the last dose
- AUC over a dosing interval (AUCtau) at first dose and last dose
Applicable for Part B.
Measured: Day 1 to Day 72
Incidence of anti-AZD9550 antibodies
- Incidence of ADA to AZD9550
Applicable for Part B.
Measured: Day 1 to Day 72
PD effect of AZD9550 on fasting glucose compared to placebo
- Absolute change in fasting glucose
Applicable for Parts C and D.
Measured: From baseline to Week 24
PD effect of AZD9550 on fasting lipid profile compared to placebo
- Absolute and percentage change in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides, and BHB
Applicable for Parts C and D.
Measured: From baseline to Week 24
The effect of AZD9550 on hepatic fat fraction versus placebo after 13 and 24 weeks of treatment
- Change in hepatic fat fraction as measured by MRI-PDFF
- Percent change in hepatic fat fraction as measured by MRI-PDFF
Applicable for Part C.
Measured: From baseline to Weeks 13 and 24
Effects of AZD9550 compared to placebo on body weight
- Change in body weight
- Percent change in body weight • Proportion of participants achieving ≥ 5% body weight loss • Proportion of participants achieving ≥ 10% body weight loss
- Absolute change in percentage body fat
Applicable for Parts C and D.
Measured: From baseline to Week 24
Change in daily (24 hours) average glucose levels as measured by CGM
Applicable for Parts C and D.
Measured: From baseline to Day 176
Change in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS
Applicable for Part C.
Measured: From baseline to Weeks 13 and 24
Area Under concentration-time Curve of AZD9550 following repeat weekly SC doses
- AUC from 0 to the time of the last measured concentration (AUClast) at the first doses of each dose level and the last dose of MTD
- AUC over a dosing interval (AUCtau) at the first doses of each dose level and the last dose of MTD
Applicable for Parts C and D.
Measured: Day 1 to Day 169
Incidence of anti-AZD9550 antibodies
- Incidence of ADA to AZD9550
Applicable for Parts C and D.
Measured: Day 1 to Day 205
Change in daily (24 hours) average glucose levels as measured by CGM
Applicable for Part A (excluding during 14 days post last dose). Applicable for Part B (excluding from baseline to Week 6 and during 14 days post last dose).
Applicable for Parts C and D.
Measured: From baseline to Weeks 1, 2, 3, 4, 5, and 6, and during 14 days post last dose
Change in 7-day average glucose levels as measured by CGM
Applicable for Part A (excluding during 14 days post last dose). Applicable for Part B (excluding from baseline to Week 6 and during 14 days post last dose).
Applicable for Parts C and D.
Measured: From baseline to Weeks 1, 2, 3, 4, 5, and 6 and during 14 days post last dose
Change in coefficient of variation of glucose levels as measured by CGM over 7 days
Applicable for Part A (excluding during 14 days post last dose). Applicable for Part B (excluding from baseline to Week 6 and during 14 days post last dose).
Applicable for Parts C and D.
Measured: From baseline to Weeks 1, 2, 3, 4, 5, and 6, and during 14 days post last dose
Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 -140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 24 hours
Applicable for Part A (excluding during 14 days post last dose). Applicable for Part B (excluding from baseline to Week 6 and during 14 days post last dose).
Applicable for Parts C and D.
Measured: From baseline to Weeks 1, 2, 3, 4, 5, and 6, and during 14 days post last dose
Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 -140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 7 days
Applicable for Part A (excluding during 14 days post last dose). Applicable for Part B (excluding from baseline to Week 6 and during 14 days post last dose).
Applicable for Parts C and D.
Measured: From baseline to Weeks 1, 2, 3, 4, 5, and 6, and during 14 days post last dose
Change in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS
Applicable for Part B.
Measured: From baseline to Week 5
Percentage change in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS
Applicable for Part B.
Measured: From baseline to Week 5
Change in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS
Applicable for Part B.
Measured: From baseline to Week 5
Percentage change in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS
Applicable for Part B.
Measured: From baseline to Week 5
Change in liver volume as measured by MRI
Applicable for Part B.
Measured: From baseline to Week 5
Absolute change in body weight
Applicable for Part B.
Measured: From baseline to Week 5
Percent change in body weight
Applicable for Part B.
Measured: From baseline to Week 5
Proportion of participants achieving ≥ 5% body weight loss
Applicable for Part B.
Measured: From baseline to Week 5
Proportion of participants achieving ≥ 10% body weight loss
Applicable for Part B.
Measured: From baseline to Week 5
Change in 7-day average glucose levels as measured by CGM
Applicable for Parts C and D.
Measured: From baseline to Day 176
Change in coefficient of variation of glucose levels as measured by CGM over 7 days
Applicable for Parts C and D.
Measured: From baseline to Day 176 and during 14 days post last dose
Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 -140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 24 hours
Applicable for Parts C and D.
Measured: From baseline to Day 176
Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 -140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 7 days
Applicable for Parts C and D.
Measured: From baseline to Day 176 and during 14 days post last dose
Percentage change in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS
Applicable for Part C.
Measured: From baseline to Weeks 13 and 24
Change in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS
Applicable for Part C.
Measured: From baseline to Weeks 13 and 24
Percentage change in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS
Applicable for Part C.
Measured: From baseline to Weeks 13 and 24
Change in liver volume, visceral and SC fat as measured by MRI
Applicable for Part C.
Measured: From baseline to Weeks 13 and 24
Anti-AZD9550 antibody titre among participants with positive serum antibodies to AZD9550
- Titre of ADA to AZD9550
Applicable for Part A.
Measured: From Day 1 to 65
Maximum observed concentration of AZD9550 following repeat weekly SC doses
- Cmax at the last dose
Applicable for Part B.
Measured: Day to Day 72
Half life associated with terminal phase elimination rate constant of AZD9550 following repeat weekly SC doses
- t1/2λz at the last dose
Applicable for Part B.
Measured: Day 1 to Day 72
Time to maximum observed concentration of AZD9550 following repeat weekly SC doses
- tmax at the last dose
Applicable for Part B.
Measured: Day 1 to Day 72
Apparent oral clearance of AZD9550 following repeat weekly SC doses
- CL/F at the last dose
Applicable for Part B.
Measured: Day 1 to day 72
Apparent volume of distribution of AZD9550 following repeat weekly SC doses
- Vz/F at the last dose
Applicable for Part B.
Measured: Day 1 to Day 72
Anti-AZD9550 antibody titre among participants with positive serum antibodies to AZD9550
- Titre of ADA to AZD9550
Applicable for Part B.
Measured: Day 1 to Day 72
Maximum observed concentration of AZD9550 following repeat weekly SC doses
- Cmax at the first doses of each dose level and the last dose of MTD
Applicable for Parts C and D.
Measured: Day 1 to Day 169
Half life associated with terminal phase elimination rate constant of AZD9550 following repeat weekly SC doses
- t1/2λz at the first doses of each dose level and the last dose of MTD
Applicable for Parts C and D.
Measured: Day 1 to Day 169
Time to maximum observed concentration of AZD9550 following repeat weekly SC doses
- tmax at the first doses of each dose level and the last dose of MTD
Applicable for Parts C and D.
Measured: Day 1 to Day 169
Apparent oral clearance of AZD9550 following repeat weekly SC doses
- CL/F at the first doses of each dose level and the last dose of MTD
Applicable for Parts C and D.
Measured: Day 1 to Day 169
Apparent volume of distribution of AZD9550 following repeat weekly SC doses
- Vz/F at the first doses of each dose level and the last dose of MTD
Applicable for Parts C and D.
Measured: Day 1 to day 169
Anti-AZD9550 antibody titre among participants with positive serum antibodies to AZD9550
- Titre of ADA to AZD9550
Applicable for Parts C and D.
Measured: Day 1 to Day 205
Change in visceral and subcutaneous fat as measured by MRI
Applicable for Part B.
Measured: From baseline to week 5
PD effect of AZD9550 on glucose metabolism compared to placebo
- Percent change in fasting glucose, fasting insulin, fasting c-peptide, and HbA1c
Applicable for Part A.
Measured: From baseline to Week 4
PD effect of AZD9550 on glucose metabolism compared to placebo
- Percent change in fasting glucose, fasting insulin, fasting c-peptide, and HbA1c
Applicable for Part B.
Measured: From baseline to Week 5
PD effect of AZD9550 on glucose metabolism compared to placebo
- Percent change in fasting glucose, fasting insulin, fasting c-peptide, and HbA1c
Applicable for Parts C and D.
Measured: From baseline to Week 24
PD effect of AZD9550 on fasting insulin compared to placebo
- Absolute change in fasting insulin
Applicable for Part A.
Measured: From baseline to Week 4
PD effect of AZD9550 on fasting c-peptide compared to placebo
- Absolute change in fasting c-peptide
Applicable for Part A.
Measured: From baseline to Week 4
PD effect of AZD9550 on fasting insulin compared to placebo
- Absolute change in fasting insulin
Applicable for Parts C and D.
Measured: From baseline to Week 24
PD effect of AZD9550 on fasting c-peptide compared to placebo
- Absolute change in fasting c-peptide
Applicable for Parts C and D.
Measured: From baseline to Week 24
PD effect of AZD9550 on fasting insulin compared to placebo
- Absolute change in fasting insulin
Applicable for Part B.
Measured: From baseline to Week 5
PD effect of AZD9550 on fasting c-peptide compared to placebo
- Absolute change in fasting c-peptide
Applicable for Part B.
Measured: From baseline to Week 5
Absolute change in percentage body fat
Applicable for Part B.
Measured: From baseline to Week 5
PD effect of AZD9550 on glucose metabolism following an MMTT compared to placebo
- Percent change in glucose AUC(0-4h) measured by MMTT
- Percent change in insulin AUC(0-4h) measured by MMTT
- Percent change in c-peptide AUC(0-4h) measured by MMTT
- Absolute change in fasting glucose, fasting insulin, and fasting c-peptide
- Percent change in fasting glucose, fasting insulin, and fasting c-peptide
Applicable for Part C.
Measured: From baseline to Week 13 and Week 24
PD effect of AZD9550 on HbA1c compared to placebo
- Absolute change in HbA1c
Applicable for Part A.
Measured: From baseline to Week 4
PD effect of AZD9550 on HbA1c compared to placebo
- Absolute change in HbA1c
Applicable for Part B.
Measured: From baseline to Week 5
PD effect of AZD9550 on HbA1c compared to placebo
- Absolute change in HbA1c
Applicable for Parts C and D.
Measured: From baseline to Week 24
Prevalence, incidence, and titres of ADAs to AZD9550 following co administration of AZD9550 and AZD6234
- To assess the immunogenicity profile of AZD9550 following co administration with AZD6234.
Applicable for Part E.
Measured: After 24 weeks
Incidence and titre of ADA to AZD9550
- To evaluate the immunogenicity profile of AZD9550. Applicable for Part F.
Measured: Day 1 to Day 261
Change and percent change in body weight
- To assess the effects of AZD9550 compared to placebo on body weight
Applicable for Part F.
Measured: From baseline to Week 29
Proportion of participants achieving ≥ 5% body weight loss
- To assess the effects of AZD9550 compared to placebo on body weight
Applicable for Part F.
Measured: From baselines to Week 29
Proportion of participants achieving ≥ 10% body weight loss
- To assess the effects of AZD9550 compared to placebo on body weight
Applicable for Part F.
Measured: From baseline to Week 29
Prevalence, incidence, and titres of ADAs to AZD6234 following co administration of AZD9550 and AZD6234
- To assess the immunogenicity profile of AZD6234 following co administration with AZD9550.
Applicable for Part E.
Measured: After 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start29 Sep 2023
- Primary completion29 Jan 2027 (estimated)
- Study completion29 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will randomise approx. 120 participants and is devided in 6 parts (Part D conducted only in Japan): A: Approx. 45 participants will be screened to achieve 16 randomised. The study duration approx. 103 days. B: Approx. 90 participants will be screened to achieve 30 randomised. The study duration approx. 110 days. C: Approx. 90 participants will be screened to achieve 30 randomised. The study duration approx. 249 days. D: Approx. 35 participants will be screened to achieve 12 randomised. The study duration approx. 249 days. E: Approx. 80 participants will be screened to achieve approx. 28 randomised. The study duration approx. 249 days. F: Approx. 40 participants. The study duration will be approx. 261 days.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151964
- Sponsor's protocol ID
- D8460C00002
- Other IDs
- 2023-504215-32-00, 2023
- Acronym
- CONTEMPO
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomised, Single-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD9550 Monotherapy and Co-administration of AZD9550 and AZD6234 in Participants Living With Obesity and Overweight With or Without Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06151964
- Acronym / sponsor ID
- CONTEMPO / D8460C00002
- Conditions
- Overweight and Obesity
- Keywords
- AZD9550, AZD6234, Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, Overweight, Obese, Obesity, Diabetes Mellitus, Type 2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 166 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 29 Jan 2027 (estimated)
- Study completion
- 29 Jan 2027 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AZD9550, previously being developed for the treatment NASH, is a dual GCG and GLP-1 receptor agonist. AZD9550 is now being developed in combination with AZD6234, a SARA, for the treatment of overweight and obesity and its associated co-morbidities. Co-administration of AZD9550 and AZD6234 is currently being evaluated in participants living with obesity and overweight without T2DM in an ongoing Phase 2b study.
The purpose of this study is to investigate the safety, tolerability, and effects of increasing doses of AZD9550 monotherapy in overweight and obese participants aged 18 through 65 years living with or without T2DM, and to investigate how AZD9550 is absorbed, distributed, and eliminated from the body (Parts A-D).
In addition, the study will investigate the safety and tolerability of co-administration of AZD9550 and AZD6234 in participants living with T2DM with obesity or overweight aged 18 through 75 years (Part E), and safety and tolerability for different titration regimens for AZD9550 in participants living with obesity, but without T2DM, aged 18 through 75 years (Part F).
Detailed description
This Phase I/II, randomised, single-blind, placebo-controlled, MAD study will assess the safety and tolerability of AZD9550 monotherapy and co-administration of AZD9550 and AZD6234 and will characterise the PK and PD of AZD9550 monotherapy and co-administration of AZD9550 and AZD6234 following SC administration to overweight and obese participants living with or without T2DM. Inclusion of participants receiving placebo is appropriate for benchmarking the safety and tolerability of AZD9550 and co-administration of AZD9550 and AZD6234. A randomised and single-blind study design has been chosen to minimise bias and includes a placebo to facilitate identification of effects related to the administration of the study intervention rather than the study procedures or situation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 12
- Model description
- The study will randomise approx. 120 participants and is devided in 6 parts (Part D conducted only in Japan): A: Approx. 45 participants will be screened to achieve 16 randomised. The study duration approx. 103 days. B: Approx. 90 participants will be screened to achieve 30 randomised. The study duration approx. 110 days. C: Approx. 90 participants will be screened to achieve 30 randomised. The study duration approx. 249 days. D: Approx. 35 participants will be screened to achieve 12 randomised. The study duration approx. 249 days. E: Approx. 80 participants will be screened to achieve approx. 28 randomised. The study duration approx. 249 days. F: Approx. 40 participants. The study duration will be approx. 261 days.
| Arm | Type | Receives |
|---|---|---|
| Part A: AZD9550 | Experimental | Drug: AZD9550Multiple repeat doses of AZD9550 given as 4 once weekly SC doses for 4 weeks to 2 sequential cohorts in overweight/obese participants with or without T2DM, evaluating 2 low dose levels of AZD9550 |
| Part B: AZD9550 | Experimental | Drug: AZD9550Once weekly up-titration over 5 doses of AZD9550 in overweight/obese participants with or without T2DM |
| Part C: AZD9550 | Experimental | Drug: AZD9550Bi-weekly/monthly up-titration of AZD9550 for 24 weeks in overweight/obese participants with or without T2DM. |
| Part D: AZD9550 | Experimental | Drug: AZD9550Bi-weekly/monthly up-titration of AZD9550 for 24 weeks in overweight/obese Japanese participants with T2DM. |
| Part A: placebo | Experimental | Drug: placeboMultiple repeat doses of placebo given as 4 once weekly SC doses for 4 weeks to 2 sequential cohorts in overweight/obese participants with or without T2DM, evaluating 2 low dose levels of AZD9550 |
| Part B: placebo | Experimental | Drug: placeboOnce weekly administration of placebo over 5 doses, volume matched to the active treatment being up-titrated, in overweight/obese participants with or without T2DM |
| Part C: placebo | Experimental | Drug: placeboBi-weekly/monthly administration of placebo - volume matched to the active treatment being up-titrated - for 24 weeks in overweight/obese participants with or without T2DM. |
| Part D: placebo | Experimental | Drug: placeboBi-weekly/monthly administration of placebo - volume matched to the active treatment being up-titrated - 24 weeks in overweight/obese Japanese participants with T2DM. |
| Part E: AZD9550 and AZD6234 | Experimental | Drug: AZD9550 and AZD6234Bi-weekly/monthly up-titration of AZD9550 and AZD6234 for 24 weeks in overweight/obese participants with T2DM. |
| Part E: placebo | Experimental | Drug: placeboBi-weekly/monthly administration of placebo - volume matched to the active treatments being up-titrated - 24 weeks in overweight/obese participants with T2DM. |
| Part F: AZD9550 | Experimental | Drug: AZD9550Bi-weekly/monthly up-titration of AZD9550 for 28 weeks in obese participants without T2DM. |
| Part F: placebo | Experimental | Drug: placeboBi-weekly/monthly administration of placebo - volume matched to the active treatment - 28 weeks in obese participants without T2DM. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males or females aged 18 through 65 years (Parts A-D) or 75 years (Part E-F) at the time of screening.
- Parts A, B, C only: Participants with or without T2DM. If participants have a diagnosis of T2DM, the glucose control managed with diabetes diet and in addition to metformin treatment no more than two treatment options (with a stable dose 3 months prior to screening).
- Part D only: Participants who are diagnosed with T2DM, have inadequate glycaemic control with diet and exercise. Participants who are prescribed an oral anti-diabetic agent such as metformin, a DPP IV inhibitor, sulphonylurea, glinides, alphaglucosidase inhibitors, and an SGLT2 inhibitor may be eligible to enter the study following a washout of 4-weeks or 5-half lives (whichever is longer) washout period.
- Part E only: Participants are eligible to be included in the Part E only if they meet all of the following criteria at screening:
- Participants with a screening HbA1c value within the target range of
Key exclusion criteria (57 listed)
- Participants with T2DM (Part F) and participants with T2DM treated with insulin (Parts A-E).
- Participants with T2DM treated with more than 3 anti-diabetic therapies (Parts A-D only).
- Treatment with GLP-1RA or GLP-1RA/GIPRA within 3 months of screening (Parts A to C only) or within 35 days of randomisation or five half-lives (whichever is shorter) of dosing (Parts E and F only).
- History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- Serum calcitonin suggestive of thyroid C-cell hyperplasia (calcitonin level > 50 ng/L), medullary thyroid carcinoma, or history or family history of multiple endocrine neoplasia at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD9550Part A: A constant dose Part B: Doses of AZD9550 that increase each week Part C: Doses of AZD9550 that increase every 2 weeks, then every 4 weeks Part D: Doses of AZD9550 that increase every 2 weeks, then every 4 weeks Part F: Doses of AZD9550 that increase every 4 weeks or every 2 weeks and then every 4 weeks | Drug | Part A: AZD9550, Part B: AZD9550, Part C: AZD9550, Part D: AZD9550, Part F: AZD9550 |
| placeboMatching administration volumes for SC injection. For Part E placebo two injections of two different placebos. | Drug | Part A: placebo, Part B: placebo, Part C: placebo, Part D: placebo, Part E: placebo, Part F: placebo |
| AZD9550 and AZD6234Part E: Doses of AZD9550 and AZD6234 that increase every 2 weeks, then every 4 weeks | Drug | Part E: AZD9550 and AZD6234 |
Primary outcome
Number and percentage of participants with any AE, SAEs, AEs leading to discontinuation of study intervention, AEs with outcome of death, and AEs leading to withdrawal from study.
Time frame: Day - 35 to Day 261
Applicable for Parts A, B, C, D, E, F.
Number and percentage of participants with clinically significant changes from baseline in Vital Sign Parameters.
Time frame: Day - 35 to Day 261
Applicable for Parts A, B, C, D, E, F.
Number and percentage of participants with clinically significant changes in ECG parameters.
Time frame: Day - 35 to Day 261
Applicable for Parts A, B, C, D, E, F.
Number and percentage of participants with clinically significant changes from baseline in Clinical Laboratory Parameters
Time frame: Day - 35 to Day 261
Applicable for Parts A, B, C, D, E, F.
Area Under Concentration-Time Curve of AZD9550 following repeat weekly SC doses
Time frame: Day 1 to Day 65
* AUC from 0 to the time of the last measured concentration (AUClast) at first dose and last dose * AUC over a dosing interval (AUCtau) at first dose and last dose. Applicable for Part A.
Maximum observed concentration of AZD9550 following repeat weekly SC doses
Time frame: Day 1 to Day 65
• Cmax at first dose and last dose Applicable for Part A.
Half life associated with terminal phase elimination rate constant of AZD9550 following repeat weekly SC doses
Time frame: Day 1 to Day 65
• t1/2λz at first dose and last dose Applicable for Part A.
Time to maximum observed concentration of AZD9550 following repeat weekly SC doses
Time frame: Day 1 to Day 65
• tmax at first dose and last dose Applicable for Part A.
Apparent oral clearance of AZD9550 following repeat weekly SC doses
Time frame: Day 1 to Day 65
• CL/F at first dose and last dose Applicable for Part A.
Apparent volume of distribution of AZD9550 following repeat weekly SC doses
Time frame: Day 1 to Day 65
• Vz/F at first dose and last dose Applicable for Part A.
Ratio for AUC of AZD9550 following repeat weekly SC doses
Time frame: Day 1 to Day 65
• Rac AUCtau at last dose Applicable for Part A.
Ratio for Cmax of AZD9550 following repeat weekly SC doses
Time frame: Day 1 to Day 65
• Rac Cmax at last dose Applicable for Part A.
75 secondary outcomes
PD effect of AZD9550 on fasting glucose compared to placebo
Time frame: From baseline to Week 4
PD effect of AZD9550 on fasting lipid profile compared to placebo
Time frame: From baseline to Week 4
Absolute and percentage change in body weight from baseline
Time frame: From baseline to Week 4
Incidence of anti-AZD9550 antibodies
Time frame: From Day 1 to Day 65
Absolute change in percentage body fat from baseline
Time frame: From baseline to Week 4
PD effect of AZD9550 on fasting glucose compared to placebo
Time frame: From baseline to Week 5
PD effect of AZD9550 on fasting lipid profile compared to placebo
Time frame: From baseline to Week 5
Effect of AZD9550 on hepatic fat fraction versus placebo at Week 5
Time frame: From baseline to Week 5
PD effect of AZD9550 on glucose metabolism following an MMTT compared to placebo
Time frame: From baseline to Week 5
Area Under concentration-time Curve of AZD9550 following repeat weekly SC doses
Time frame: Day 1 to Day 72
Incidence of anti-AZD9550 antibodies
Time frame: Day 1 to Day 72
PD effect of AZD9550 on fasting glucose compared to placebo
Time frame: From baseline to Week 24
PD effect of AZD9550 on fasting lipid profile compared to placebo
Time frame: From baseline to Week 24
The effect of AZD9550 on hepatic fat fraction versus placebo after 13 and 24 weeks of treatment
Time frame: From baseline to Weeks 13 and 24
Effects of AZD9550 compared to placebo on body weight
Time frame: From baseline to Week 24
Change in daily (24 hours) average glucose levels as measured by CGM
Time frame: From baseline to Day 176
Change in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS
Time frame: From baseline to Weeks 13 and 24
Area Under concentration-time Curve of AZD9550 following repeat weekly SC doses
Time frame: Day 1 to Day 169
Incidence of anti-AZD9550 antibodies
Time frame: Day 1 to Day 205
Change in daily (24 hours) average glucose levels as measured by CGM
Time frame: From baseline to Weeks 1, 2, 3, 4, 5, and 6, and during 14 days post last dose
Change in 7-day average glucose levels as measured by CGM
Time frame: From baseline to Weeks 1, 2, 3, 4, 5, and 6 and during 14 days post last dose
Change in coefficient of variation of glucose levels as measured by CGM over 7 days
Time frame: From baseline to Weeks 1, 2, 3, 4, 5, and 6, and during 14 days post last dose
Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 -140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 24 hours
Time frame: From baseline to Weeks 1, 2, 3, 4, 5, and 6, and during 14 days post last dose
Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 -140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 7 days
Time frame: From baseline to Weeks 1, 2, 3, 4, 5, and 6, and during 14 days post last dose
Change in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS
Time frame: From baseline to Week 5
Percentage change in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS
Time frame: From baseline to Week 5
Change in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS
Time frame: From baseline to Week 5
Percentage change in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS
Time frame: From baseline to Week 5
Change in liver volume as measured by MRI
Time frame: From baseline to Week 5
Absolute change in body weight
Time frame: From baseline to Week 5
Percent change in body weight
Time frame: From baseline to Week 5
Proportion of participants achieving ≥ 5% body weight loss
Time frame: From baseline to Week 5
Proportion of participants achieving ≥ 10% body weight loss
Time frame: From baseline to Week 5
Change in 7-day average glucose levels as measured by CGM
Time frame: From baseline to Day 176
Change in coefficient of variation of glucose levels as measured by CGM over 7 days
Time frame: From baseline to Day 176 and during 14 days post last dose
Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 -140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 24 hours
Time frame: From baseline to Day 176
Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 -140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 7 days
Time frame: From baseline to Day 176 and during 14 days post last dose
Percentage change in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS
Time frame: From baseline to Weeks 13 and 24
Change in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS
Time frame: From baseline to Weeks 13 and 24
Percentage change in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS
Time frame: From baseline to Weeks 13 and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD9550 and AZD9550 and AZD6234 in people with Overweight and Obesity, run by AstraZeneca at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 57 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada, Germany, Japan, Austria, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of participants with any AE, SAEs, AEs leading to discontinuation of study intervention, AEs with outcome of death, and AEs leading to withdrawal from study. (time frame: Day - 35 to Day 261). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.