Healthy ParticipantsPhase 1NCT07911514
A Trial to Assess the Relative Bioavailability of Different Subcutaneous Formulations of AZD9550 and AZD6234
A Phase 1 study testing AZD9550 solution for injection, AZD6234 solution for injection and Formulation 1 solution for injection in people with Healthy Participants, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This study in healthy volunteers aims to compare blood levels and side effects after administration of different formulations of two test medicines, AZD9550 and AZD6234. This study will take place at one site in Nottingham, United Kingdom, and will randomize 60 healthy men and women aged 18-55 years living with… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD9550 solution for injection, AZD6234 solution for injection and Formulation 1 solution for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Nov 2026to 4 May 2027
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or non-pregnant, non-lactating females aged 18 to 55 years inclusive
- BMI of 25.0 to 35.0 kg/m2 inclusive and weight ≥50 kg
Who cannot join
- History of any clinically important disease or disorder
- History or presence of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric or GI disorder including a history of pancreatitis or gall stones
- History of suicidal ideation or behaviour
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of dosing
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to any component of the AZD6234 or AZD9550 drug products
- Prior or planned bariatric surgery or placement of a weight loss device
Show all 27Show fewer
- Participants who do not have suitable veins for multiple venepunctures/cannulation
- Skin disorder/condition or tattoos in the abdominal area of the proposed injection site which can interfere with study assessments
- Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis
- Basal calcitonin level > 50 ng/L
- Any clinically significant abnormal findings in vital signs
- Any clinically significant abnormalities on 12-lead ECG
- HbA1c ≥6.5% (≥48 mmol/mol)
- Evidence of renal impairment
- Females who are pregnant or lactating
- Participants who have received any IMP in the last 90 days prior to dosing
- Participants who have previously received AZD9550 and/or AZD6234
- Treatment with prescription or non-prescription medication intended for weight loss within 3 months before screening
- Treatment with a GLP-1-containing preparation within 3 months before screening
- Treatment with an amylin analogue containing preparation within 30 days before screening
- Treatment with medication for diabetes within 3 months before screening
- Treatment with medication associated with significant weight gain in the 3 months before screening
- Plasma donation within 3 months of screening or any blood donation/loss more than 500 mL within 3 months before screening
- Use of any prescribed or non-prescribed medication including antacids, gastric pH modifying agents, analgesics, herbal remedies, vitamins and minerals within 2 weeks of dosing
- Use of drugs or herbal medications with CYP3A4 enzyme-inducing properties within 3 weeks of dosing
- Current smokers or known or suspected history of alcohol or drug abuse
- Excessive intake of caffeine-containing drinks or food
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
Official title: A Phase I, Single-Dose, Randomised, Parallel-Group, Open-Label Trial to Assess the Relative Bioavailability of Different Subcutaneous Formulations of AZD9550 and AZD6234 in Participants Living With Overweight or Obesity
This study in healthy volunteers aims to compare blood levels and side effects after administration of different formulations of two test medicines, AZD9550 and AZD6234.
This study will take place at one site in Nottingham, United Kingdom, and will randomize 60 healthy men and women aged 18-55 years living with overweight/obesity.
Read the detailed description
This study in healthy volunteers aims to compare blood levels and side effects after administration of different formulations of two test medicines, AZD9550 and AZD6234.
This study will take place at one site in Nottingham, United Kingdom.
It plans to randomize 60 healthy men and women aged 18-55 years living with overweight/obesity.
Each volunteer will receive a single dose of test medicine by injection under the skin into the abdomen (tummy), either as 2 separate injections (one of each test medicine) or as a single injection where the test medicines are combined. They'll stay in the clinic for 6 nights on 1 occasion, attend up to 5 outpatient visits, and take up to 9 weeks to finish the study.
Blood and urine samples will be collected to measure the amounts of AZD6234 and AZD9550 and a component of the test medicine, do safety tests, and assess the effect of the test medicine on the immune system.
- Conditions
- Healthy Participants
- Being tested
- AZD9550 solution for injection, AZD6234 solution for injection, Formulation 1 solution for injection, Formulation 2 solution for injection, Formulation 3 solution for injection
- Keywords
- Relative bioavailability, Pharmacokinetics, Obesity, Overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9550 solution for injectionDrug
Also called AZD9550
AZD9550 solution for injection will be administered as a single SC injection
AZD6234 solution for injectionDrug
Also called AZD6234
AZD6234 solution for injection will be administered as a single SC injection
Formulation 1 solution for injectionDrug
Also called AZD9550+AZD6234
Formulation 1 solution for injection will be administered as a single SC injection
Formulation 2 solution for injectionDrug
Also called AZD9550+AZD6234
Formulation 2 solution for injection will be administered as a single SC injection
Formulation 3 solution for injectionDrug
Also called AZD9550+AZD6234
Formulation 3 solution for injection will be administered as a single SC injection
Formulation 4 solution for injectionDrug
Also called AZD9550+AZD6234
Formulation 4 solution for injection will be administered as a single SC injection
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | Participants will receive single concomitant SC injections of AZD9550 solution for injection and AZD6234 solution for injection Receives: Drug: AZD9550 solution for injection; Drug: AZD6234 solution for injection |
| Regimen B | Experimental | Participants will receive a single SC injection of Formulation 1 solution for injection Receives: Drug: Formulation 1 solution for injection |
| Regimen C | Experimental | Participants will receive a single SC injection of Formulation 2 solution for injection Receives: Drug: Formulation 2 solution for injection |
| Regimen D | Experimental | Participants will receive a single SC injection of Formulation 3 solution for injection Receives: Drug: Formulation 3 solution for injection |
| Regimen E | Experimental | Participants will receive a single SC injection of Formulation 4 solution for injection Receives: Drug: Formulation 4 solution for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Assess the relative bioavailability (rBA) and compare single subcutaneous (SC) dose pharmacokinetics (PK) of concomitant doses of AZD9550 and AZD6234 to different fixed-dose coformulations
Measured: Plasma sample collection from pre dose to Day 22
Area under the curve from time 0 to the time of last quantifiable concentration (AUClast)
Assess the relative bioavailability (rBA) and compare the single subcutaneous (SC) dose pharmacokinetics (PK) of concomitant doses of AZD9550 and AZD6234 to different fixed-dose coformulations
Measured: Plasma sample collection from pre dose to Day 22
Area under the curve from time 0 extrapolated to infinity (AUCinf)
Assess the relative bioavailability (rBA) and compare the single subcutaneous (SC) dose pharmacokinetics (PK) of concomitant doses of AZD9550 and AZD6234 to different fixed-dose coformulations
Measured: Plasma sample collection from pre dose to Day 22
Secondary outcomes (9)
Number of participants with adverse events (AEs)/serious AEs (SAEs), and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests
Safety and tolerability of single concomitant doses and different fixed-dose coformulations of AZD9550 and AZD6234 following a single subcutaneous (SC) dose
Measured: Through study duration, approximately 9 weeks
Time of maximum observed concentration (tmax)
Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformulations
Measured: Plasma sample collection from pre dose to Day 22
Time of last measurable observed concentration (tlast)
Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformuations
Measured: Plasma sample collection from pre dose to Day 22
Time prior to the first measurable concentration (tlag)
Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformulations
Measured: Plasma sample collection from pre dose to Day 22
Terminal elimination half-life (t1/2λz)
Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformulations
Measured: Plasma sample collection from pre dose to Day 22
Apparent total body clearance (CL/F)
Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformulations
Measured: Plasma sample collection from pre dose to Day 22
Apparent volume of distribution based on the terminal phase (Vz/F)
Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformulations
Measured: Plasma sample collection from pre dose to Day 22
Mean residence time from time 0 extrapolated to infinity (MRTinf)
Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformulations
Measured: Plasma sample collection from pre dose to Day 22
First order rate constant associated with the terminal (log-linear) portion of the curve (λz)
Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformulations
Measured: Plasma sample collection from pre dose to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start9 Nov 2026 (estimated)
- Primary completion4 May 2027 (estimated)
- Study completion4 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Regimens A to E are each single arm regimens.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911514
- Sponsor's protocol ID
- D8460C00005
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Dose, Randomised, Parallel-Group, Open-Label Trial to Assess the Relative Bioavailability of Different Subcutaneous Formulations of AZD9550 and AZD6234 in Participants Living With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07911514
- Acronym / sponsor ID
- D8460C00005
- Conditions
- Healthy Participants
- Keywords
- Relative bioavailability, Pharmacokinetics, Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 9 Nov 2026 (estimated)
- Primary completion
- 4 May 2027 (estimated)
- Study completion
- 4 May 2027 (estimated)
- First posted
- 2 Nov 2026 (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.
This study in healthy volunteers aims to compare blood levels and side effects after administration of different formulations of two test medicines, AZD9550 and AZD6234.
This study will take place at one site in Nottingham, United Kingdom, and will randomize 60 healthy men and women aged 18-55 years living with overweight/obesity.
Detailed description
This study in healthy volunteers aims to compare blood levels and side effects after administration of different formulations of two test medicines, AZD9550 and AZD6234.
This study will take place at one site in Nottingham, United Kingdom.
It plans to randomize 60 healthy men and women aged 18-55 years living with overweight/obesity.
Each volunteer will receive a single dose of test medicine by injection under the skin into the abdomen (tummy), either as 2 separate injections (one of each test medicine) or as a single injection where the test medicines are combined. They'll stay in the clinic for 6 nights on 1 occasion, attend up to 5 outpatient visits, and take up to 9 weeks to finish the study.
Blood and urine samples will be collected to measure the amounts of AZD6234 and AZD9550 and a component of the test medicine, do safety tests, and assess the effect of the test medicine on the immune system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Regimens A to E are each single arm regimens.
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: AZD9550 solution for injection, Drug: AZD6234 solution for injectionParticipants will receive single concomitant SC injections of AZD9550 solution for injection and AZD6234 solution for injection |
| Regimen B | Experimental | Drug: Formulation 1 solution for injectionParticipants will receive a single SC injection of Formulation 1 solution for injection |
| Regimen C | Experimental | Drug: Formulation 2 solution for injectionParticipants will receive a single SC injection of Formulation 2 solution for injection |
| Regimen D | Experimental | Drug: Formulation 3 solution for injectionParticipants will receive a single SC injection of Formulation 3 solution for injection |
| Regimen E | Experimental | Drug: Formulation 4 solution for injectionParticipants will receive a single SC injection of Formulation 4 solution for injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males or non-pregnant, non-lactating females aged 18 to 55 years inclusive
- BMI of 25.0 to 35.0 kg/m2 inclusive and weight ≥50 kg
Key exclusion criteria (27 listed)
- History of any clinically important disease or disorder
- History or presence of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric or GI disorder including a history of pancreatitis or gall stones
- History of suicidal ideation or behaviour
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of dosing
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to any component of the AZD6234 or AZD9550 drug products
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 |
|---|---|---|
| AZD9550 solution for injectionAlso: AZD9550AZD9550 solution for injection will be administered as a single SC injection | Drug | Regimen A |
| AZD6234 solution for injectionAlso: AZD6234AZD6234 solution for injection will be administered as a single SC injection | Drug | Regimen A |
| Formulation 1 solution for injectionAlso: AZD9550+AZD6234Formulation 1 solution for injection will be administered as a single SC injection | Drug | Regimen B |
| Formulation 2 solution for injectionAlso: AZD9550+AZD6234Formulation 2 solution for injection will be administered as a single SC injection | Drug | Regimen C |
| Formulation 3 solution for injectionAlso: AZD9550+AZD6234Formulation 3 solution for injection will be administered as a single SC injection | Drug | Regimen D |
| Formulation 4 solution for injectionAlso: AZD9550+AZD6234Formulation 4 solution for injection will be administered as a single SC injection | Drug | Regimen E |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Plasma sample collection from pre dose to Day 22
Assess the relative bioavailability (rBA) and compare single subcutaneous (SC) dose pharmacokinetics (PK) of concomitant doses of AZD9550 and AZD6234 to different fixed-dose coformulations
Area under the curve from time 0 to the time of last quantifiable concentration (AUClast)
Time frame: Plasma sample collection from pre dose to Day 22
Assess the relative bioavailability (rBA) and compare the single subcutaneous (SC) dose pharmacokinetics (PK) of concomitant doses of AZD9550 and AZD6234 to different fixed-dose coformulations
Area under the curve from time 0 extrapolated to infinity (AUCinf)
Time frame: Plasma sample collection from pre dose to Day 22
Assess the relative bioavailability (rBA) and compare the single subcutaneous (SC) dose pharmacokinetics (PK) of concomitant doses of AZD9550 and AZD6234 to different fixed-dose coformulations
9 secondary outcomes
Number of participants with adverse events (AEs)/serious AEs (SAEs), and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests
Time frame: Through study duration, approximately 9 weeks
Time of maximum observed concentration (tmax)
Time frame: Plasma sample collection from pre dose to Day 22
Time of last measurable observed concentration (tlast)
Time frame: Plasma sample collection from pre dose to Day 22
Time prior to the first measurable concentration (tlag)
Time frame: Plasma sample collection from pre dose to Day 22
Terminal elimination half-life (t1/2λz)
Time frame: Plasma sample collection from pre dose to Day 22
Apparent total body clearance (CL/F)
Time frame: Plasma sample collection from pre dose to Day 22
Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: Plasma sample collection from pre dose to Day 22
Mean residence time from time 0 extrapolated to infinity (MRTinf)
Time frame: Plasma sample collection from pre dose to Day 22
First order rate constant associated with the terminal (log-linear) portion of the curve (λz)
Time frame: Plasma sample collection from pre dose to Day 22
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 2 Nov 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.
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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.
AstraZeneca Clinical Study Information Center contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD9550 solution for injection, AZD6234 solution for injection and Formulation 1 solution for injection in people with Healthy Participants, run by AstraZeneca at 1 site in United Kingdom.
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 2 inclusion and 27 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 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.
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?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) (time frame: Plasma sample collection from pre dose to Day 22). The study lists 3 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 2 Nov 2026.