Non-alcoholic SteatohepatitisPhase 1NCT05294458
A Randomised, Open-Label Study to Evaluate the Relative and Absolute Bioavailability of Cotadutide in Healthy Subjects
A Phase 1 study testing cotadutide solution for injection in people with Non-alcoholic Steatohepatitis and Type 2 Diabetes Mellitus (T2DM), run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The Sponsor is developing the test medicine, cotadutide, for the potential treatment of non-alcoholic steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM) with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Steatohepatitis, Type 2 Diabetes Mellitus (T2DM), Chronic Kidney Disease
- What is being tested?
- cotadutide solution for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Mar 2022to 12 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy males or non-pregnant, non-lactating healthy females aged 18 to 55 years at the time of signing informed consent.
- Females must have a negative serum pregnancy test at screening and a negative urine pregnancy test on admission to the unit, must not be lactating, confirmed at screening and fulfil the criteria detailed in Section 9.4.
- Have a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
- Must be willing and able to communicate and participate in the whole study.
- Subjects must have been received both doses of the SARS-CoV-2 vaccine.
- Must agree to adhere to the contraception requirements defined in Section 9.4
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
- History or presence of any disease or condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Evidence of renal impairment at screening, as indicated by an estimated eGFR of <60 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- A personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2.
- Thyroid C-cell hyperplasia (calcitonin level > 50 ng/L) or medullary thyroid carcinoma at screening.
- History of clinically significant cardiovascular, renal, hepatic, dermatological, respirator, neurological, psychiatric or gastrointestinal disease disorder including a history of pancreatitis.
Show all 30Show fewer
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, at screening as judged by the investigator.
- Amylase and/or lipase >1.5 × upper limit of normal (ULN) at screening
- Any clinically significant abnormal findings in vital signs, at screening and/or first admission to the study unit, as judged by the investigator.
- Any clinically significant abnormalities on 12-lead ECG, including but not limited to QTcF >450 msec, at screening, as judged by the investigator.
- Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), and human immunodeficiency virus (HIV) antibody.
- Evidence of current infection with SARS-Cov-2.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer. Note: subjects consented and screened, but not randomised in this study or a previous phase I study, are not excluded.
- Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to cotadutide. Hay fever is allowed unless it is active
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission.
- Positive screen for drugs of abuse at screening or on each admission to the study centre or positive screen for alcohol on each admission to the study centre.
- Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen, hormonal contraception and hormonal replacement therapy), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the two weeks prior to the first administration of IMP or longer if the medication has a long half-life. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no pharmacodynamic activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardize the safety of the trial subject; and if the use of medication is not considered to interfere with the objectives of the study
- Known or suspected history of alcohol or drug abuse in the past 2 years or excessive intake of alcohol (>21 units per week for men and >14 units per week or women [1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type]) or as judged by the investigator. A confirmed positive alcohol breath test at screening or admission.
- Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate) as judged by the investigator. Excessive intake of caffeine defined as the regular consumption of more than 600 mg of caffeine per day (e.g., >5 cups of coffee) or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the investigational site.
- Involvement of any Astra Zeneca, Quotient or study site employee or their close relatives.
- Subjects who have previously received cotadutide.
- Any subject who has received a GLP-1 analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening.
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening.
- Skin disorder/condition or tattoos in the area of the proposed injection site which can interfere with assessments required by protocol.
- Judgment by the investigator that the volunteer should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
- Subjects who cannot communicate reliably with the investigator.
- Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
- Failure to satisfy the investigator of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Part, Three-Way Crossover, Randomised, Open-Label Study Designed to Evaluate the Relative and Absolute Bioavailability Following a Single Subcutaneous Injection of a Novel High Concentration Subcutaneous Formulation of Cotadutide Against a Low Concentration Subcutaneous Formulation and Intravenous (IV) Formulation for Reference, in Healthy Subjects
The Sponsor is developing the test medicine, cotadutide, for the potential treatment of non-alcoholic steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM) with chronic kidney disease. This healthy volunteer study will try to identify how two different concentrations of cotadutide are taken up by the body when dosed under the skin (subcutaneous injection). The study will also try to identify the absolute bioavailability of cotadutide (amount taken up by the body when dosed under the skin compared to an injection directly into the vein (intravenous)). This is a single-part, three-period study taking place at one non-NHS site in the UK and will involve 12 male and female (non-pregnant/non-lactating) volunteers aged 18-55. For each study period, on Day 1 volunteers will receive cotadutide as either a subcutaneous injection (into the stomach) or an intravenous injection following an overnight fast of at least 10 hours. The subcutaneous injections will be given as either a 1 mg/ml or 5 mg/ml concentration. The intravenous injection will be given as a 0.1 mg/ml concentration. Volunteers will be discharged on Day 4 and there will be a washout period of 7 days between dosing.
Blood samples will be taken at regular intervals for pharmacokinetics and safety assessments from Day -1 to discharge. Volunteers will need to return for a follow up visit 28 (±2) days post-first dose for provisional of an anti-drug antibody sample and to ensure wellbeing
Read the detailed description
The Sponsor is developing the test medicine, cotadutide, for the potential treatment of non-alcoholic steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM) with chronic kidney disease. NASH is a common liver disease characteristic of a damaged liver that may no longer work properly. T2DM is a condition that causes sugar (glucose) levels in the blood to become too high which can damage the blood vessels within the kidney leading to chronic kidney disease and also causing problems with eyes, heart and nerves. This healthy volunteer study will try to identify how two different concentrations of cotadutide are taken up by the body when dosed under the skin (subcutaneous injection). The study will also try to identify the absolute bioavailability of cotadutide (amount taken up by the body when dosed under the skin compared to an injection directly into the vein (intravenous)). The study will also assess the safety and tolerability of cotadutide.
This is a single-part, three-period study taking place at one non-NHS site in the UK and will involve 12 male and female (non-pregnant/non-lactating) volunteers aged 18-55. For each study period, on Day 1 volunteers will receive cotadutide as either a subcutaneous injection (into the stomach) or an intravenous injection following an overnight fast of at least 10 hours. The subcutaneous injections will be given as either a 1 mg/ml or 5 mg/ml concentration. The intravenous injection will be given as a 0.1 mg/ml concentration. Volunteers will be discharged on Day 4 and there will be a washout period of 7 days between dosing.
Blood samples will be taken at regular intervals for pharmacokinetics and safety assessments from Day -1 to discharge. Volunteers will need to return for a followup visit 28 (±2) days post-first dose for provisional of an anti-drug antibody sample and to ensure wellbeing
- Being tested
- cotadutide solution for injection
- Keywords
- Steatohepatitis, Diabetes, Kidney disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Fatty Liver, Diabetes Mellitus, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cotadutide solution for injectionDrug
cotadutide solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Cotadutide solution for injection | Experimental | Period 1, subcutaneous injection of cotadutide solution
Period 2, subcutaneous injection of cotadutide solution
Period 3, subcutaneous injection of cotadutide solution Receives: Drug: cotadutide solution for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability of the high and the low concentration cotadutide SC formulations
Evaluation of the absolute bioavailability (F) of the SC formulations by comparison of AUCsubcut/AUCIV
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Maximum observed concentration (cmax)
Assessment of pharmacokinetics and relative bioavailability of cotadutide solution for injection by measuring maximum observed concentration (cmax)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Relative bioavailability of a high concentration cotadutide SC formulation in comparison to low concentration formulation, in the fasted state
Pharmacokinetic parameters AUC0-t for cotadutide in the high concentration and low concentration regimens
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Relative bioavailability of a high concentration cotadutide SC formulation in comparison to low concentration formulation, in the fasted state
Pharmacokinetic parameters AUC0-inf for cotadutide in the high concentration and low concentration regimens
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Secondary outcomes (13)
Provide additional details on the single dose PK of cotadutide
Pharmacokinetic parameters tmax, for cotadutide, as applicable
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Pharmacokinetic parameters Cmax, for cotadutide, as applicable
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Pharmacokinetic parameters AUC0-t, for cotadutide, as applicable
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Pharmacokinetic parameters AUC0-inf, for cotadutide, as applicable
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Pharmacokinetic parameters t1/2, for cotadutide, as applicable
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Pharmacokinetic parameters λz, for cotadutide, as applicable
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Pharmacokinetic parameters CL (IV dose), for cotadutide, as applicable
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Pharmacokinetic parameters CL/F, for cotadutide, as applicable
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Pharmacokinetic parameters Vz, for cotadutide, as applicable
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Pharmacokinetic parameters Vz/F, for cotadutide, as applicable
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Pharmacokinetic parameters MRTinf, for cotadutide, as applicable
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Number of adverse events (AEs) experienced by subjects
Safety and tolerability assessed through the incidence of AEs
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Evaluate immunogenicity for cotadutide administered as low and high concentration SC formulations and an IV formulation
ADA incidence and titre
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start28 Mar 2022
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic SteatohepatitisStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Somasekhara Menakuru, MBBS, MS, MRCS, DPM, MFPM, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294458
- Sponsor's protocol ID
- D5671C00009
- Other IDs
- 2021-005442-15
- Status last verified
- Jul 2025
- First submitted
- 11 Mar 2022
- Last updated
- 20 Jul 2025
- 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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Part, Three-Way Crossover, Randomised, Open-Label Study Designed to Evaluate the Relative and Absolute Bioavailability Following a Single Subcutaneous Injection of a Novel High Concentration Subcutaneous Formulation of Cotadutide Against a Low Concentration Subcutaneous Formulation and Intravenous (IV) Formulation for Reference, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05294458
- Acronym / sponsor ID
- D5671C00009
- Keywords
- Steatohepatitis, Diabetes, Kidney disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 24 Mar 2022 (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.
The Sponsor is developing the test medicine, cotadutide, for the potential treatment of non-alcoholic steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM) with chronic kidney disease. This healthy volunteer study will try to identify how two different concentrations of cotadutide are taken up by the body when dosed under the skin (subcutaneous injection). The study will also try to identify the absolute bioavailability of cotadutide (amount taken up by the body when dosed under the skin compared to an injection directly into the vein (intravenous)). This is a single-part, three-period study taking place at one non-NHS site in the UK and will involve 12 male and female (non-pregnant/non-lactating) volunteers aged 18-55. For each study period, on Day 1 volunteers will receive cotadutide as either a subcutaneous injection (into the stomach) or an intravenous injection following an overnight fast of at least 10 hours. The subcutaneous injections will be given as either a 1 mg/ml or 5 mg/ml concentration. The intravenous injection will be given as a 0.1 mg/ml concentration. Volunteers will be discharged on Day 4 and there will be a washout period of 7 days between dosing.
Blood samples will be taken at regular intervals for pharmacokinetics and safety assessments from Day -1 to discharge. Volunteers will need to return for a follow up visit 28 (±2) days post-first dose for provisional of an anti-drug antibody sample and to ensure wellbeing
Detailed description
The Sponsor is developing the test medicine, cotadutide, for the potential treatment of non-alcoholic steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM) with chronic kidney disease. NASH is a common liver disease characteristic of a damaged liver that may no longer work properly. T2DM is a condition that causes sugar (glucose) levels in the blood to become too high which can damage the blood vessels within the kidney leading to chronic kidney disease and also causing problems with eyes, heart and nerves. This healthy volunteer study will try to identify how two different concentrations of cotadutide are taken up by the body when dosed under the skin (subcutaneous injection). The study will also try to identify the absolute bioavailability of cotadutide (amount taken up by the body when dosed under the skin compared to an injection directly into the vein (intravenous)). The study will also assess the safety and tolerability of cotadutide.
This is a single-part, three-period study taking place at one non-NHS site in the UK and will involve 12 male and female (non-pregnant/non-lactating) volunteers aged 18-55. For each study period, on Day 1 volunteers will receive cotadutide as either a subcutaneous injection (into the stomach) or an intravenous injection following an overnight fast of at least 10 hours. The subcutaneous injections will be given as either a 1 mg/ml or 5 mg/ml concentration. The intravenous injection will be given as a 0.1 mg/ml concentration. Volunteers will be discharged on Day 4 and there will be a washout period of 7 days between dosing.
Blood samples will be taken at regular intervals for pharmacokinetics and safety assessments from Day -1 to discharge. Volunteers will need to return for a followup visit 28 (±2) days post-first dose for provisional of an anti-drug antibody sample and to ensure wellbeing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cotadutide solution for injection | Experimental | Drug: cotadutide solution for injectionPeriod 1, subcutaneous injection of cotadutide solution Period 2, subcutaneous injection of cotadutide solution Period 3, subcutaneous injection of cotadutide solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy males or non-pregnant, non-lactating healthy females aged 18 to 55 years at the time of signing informed consent.
- Females must have a negative serum pregnancy test at screening and a negative urine pregnancy test on admission to the unit, must not be lactating, confirmed at screening and fulfil the criteria detailed in Section 9.4.
- Have a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
- Must be willing and able to communicate and participate in the whole study.
Key exclusion criteria (30 listed)
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
- History or presence of any disease or condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Evidence of renal impairment at screening, as indicated by an estimated eGFR of <60 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- A personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2.
- Thyroid C-cell hyperplasia (calcitonin level > 50 ng/L) or medullary thyroid carcinoma 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 |
|---|---|---|
| cotadutide solution for injectioncotadutide solution for injection | Drug | Cotadutide solution for injection |
Primary outcome
Absolute bioavailability of the high and the low concentration cotadutide SC formulations
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Evaluation of the absolute bioavailability (F) of the SC formulations by comparison of AUCsubcut/AUCIV
Maximum observed concentration (cmax)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Assessment of pharmacokinetics and relative bioavailability of cotadutide solution for injection by measuring maximum observed concentration (cmax)
Relative bioavailability of a high concentration cotadutide SC formulation in comparison to low concentration formulation, in the fasted state
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Pharmacokinetic parameters AUC0-t for cotadutide in the high concentration and low concentration regimens
Relative bioavailability of a high concentration cotadutide SC formulation in comparison to low concentration formulation, in the fasted state
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Pharmacokinetic parameters AUC0-inf for cotadutide in the high concentration and low concentration regimens
13 secondary outcomes
Provide additional details on the single dose PK of cotadutide
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Provide additional details on the single dose PK of cotadutide
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Number of adverse events (AEs) experienced by subjects
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Evaluate immunogenicity for cotadutide administered as low and high concentration SC formulations and an IV formulation
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- The redacted CSR D5671C00009Link provided by the sponsor.
- 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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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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.
Somasekhara Menakuru, MBBS, MS, MRCS, DPM, MFPM principal investigator
Quotient Sciences
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 cotadutide solution for injection in people with Non-alcoholic Steatohepatitis and Type 2 Diabetes Mellitus (T2DM), 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 7 inclusion and 30 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: finished, as of the sponsor's last update on 20 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Absolute bioavailability of the high and the low concentration cotadutide SC formulations (time frame: Collection of plasma samples from pre-dose to 72 hours post-dose.). The study lists 4 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 20 Jul 2025.