A Phase 2 interventional study of Cotadutide and Placebo in Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis, sponsored by AstraZeneca. Completed at 115 sites in 20 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.
A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of two different doses of cotadutide at 300 and 600 μg in participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis.
1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's enrollment of 54 is close to the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Histologically confirmed non-alcoholic steatohepatitis (NASH) per NASH Clinical Research Network (CRN) criteria as diagnosed by histology from a liver biopsy performed ≤ 180 days from randomization and fulfilling all of the following histological criteria:
Exclusion Criteria:
Drug: Cotadutide
Drug: Placebo
Drug: Cotadutide
Drug: Placebo
Cotadutide administered subcutaneously once daily
Placebo administered subcutaneously once daily
Number of Participants With Adverse Events (AEs).
To assess safety and tolerability of Cotadutide. Occurrence of AEs and serious AEs, including AEs leading to dose reduction, and AEs of special interest.
Time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
Number of Participants With Abnormal Vital Signs.
To assess safety and tolerability of Cotadutide.
Time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
Number of Participants With Abnormal Laboratory Assessments
To assess safety and tolerability of Cotadutide.
Time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
Number of Participants With Treatment Emergent Abnormality in 12-lead Electrocardiogram (ECG).
To assess safety and tolerability of Cotadutide.
Time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
Number of Treatment-induced Anti-Drug Antibody (ADA) Participants
To assess the immunogenicity of Cotadutide
Time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
Titer of Treatment-induced Anti-Drug Antibody (ADA)
To assess the immunogenicity of cotadutide. Titers represent a dilution and are therefore unitless. Summary statistics are based on the maximum observed titer for each ADA positive subject within the time frame.
Time frame: From first dose on Day 1 until the follow-up period, 28 days post last dose (from randomization up to approximately 52 weeks).
| Milestone | Cotadutide 300 ug | Cotadutide 600 ug | Placebo 600 ug | Placebo 300 ug |
|---|---|---|---|---|
| Started | 17 | 18 | 9 | 10 |
| Completed | 14 | 14 | 5 | 8 |
| Not completed | 3 | 4 | 4 | 2 |
| Withdrew: Adverse event | 0 | 2 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 3 | 2 |
| Withdrew: Study terminated by sponsor (reason as collected in database, study was not terminated) | 0 | 1 | 0 | 0 |
| Withdrew: Discontinued | 1 | 0 | 0 | 0 |
To assess safety and tolerability of Cotadutide. Occurrence of AEs and serious AEs, including AEs leading to dose reduction, and AEs of special interest.
| Participants | Cotadutide 300 ug | Cotadutide 600 ug | Placebo |
|---|---|---|---|
| Number of Participants With Adverse Events (AEs). | 16 | 16 | 13 |
To assess safety and tolerability of Cotadutide.
| Participants | Cotadutide 300 ug | Cotadutide 600 ug | Placebo |
|---|---|---|---|
| Number of Participants With Abnormal Vital Signs. | 13 | 14 | 17 |
To assess safety and tolerability of Cotadutide.
| Participants | Cotadutide 300 ug | Cotadutide 600 ug | Placebo |
|---|---|---|---|
| Number of Participants With Abnormal Laboratory Assessments | 16 | 17 | 19 |
To assess safety and tolerability of Cotadutide.
| Participants | Cotadutide 300 ug | Cotadutide 600 ug | Placebo |
|---|---|---|---|
| Number of Participants With Treatment Emergent Abnormality in 12-lead Electrocardiogram (ECG). | 4 | 2 | 6 |
To assess the immunogenicity of Cotadutide
| Participants | Cotadutide 300 ug | Cotadutide 600 ug | Placebo |
|---|---|---|---|
| Number of Treatment-induced Anti-Drug Antibody (ADA) Participants | 7 | 11 | 0 |
To assess the immunogenicity of cotadutide. Titers represent a dilution and are therefore unitless. Summary statistics are based on the maximum observed titer for each ADA positive subject within the time frame.
| titer | Cotadutide 300 ug | Cotadutide 600 ug |
|---|---|---|
| Titer of Treatment-induced Anti-Drug Antibody (ADA) | 240 (15 to 7680) | 60 (15 to 240) |
Collected over From first dose on Day 1 up to approximately 52 weeks.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cotadutide 300 ug | 1/17 (5.9%) | 1/17 (5.9%) | 16/17 (94.1%) |
| Cotadutide 600 ug | 0/18 (0%) | 0/18 (0%) | 17/18 (94.4%) |
| Placebo 600 ug | 0/9 (0%) | 0/9 (0%) | 5/9 (55.6%) |
| Placebo 300 ug | 0/10 (0%) | 0/10 (0%) | 8/10 (80%) |
| Event | Cotadutide 300 ug | Cotadutide 600 ug | Placebo 600 ug | Placebo 300 ug |
|---|---|---|---|---|
| Atrioventricular block completeCardiac disorders | 1/17 | 0/18 | 0/9 | 0/10 |
| Pacemaker generated arrhythmiaGeneral disorders | 1/17 | 0/18 | 0/9 | 0/10 |
| Atrioventricular block second degreeCardiac disorders | 1/17 | 0/18 | 0/9 | 0/10 |
| Event | Cotadutide 300 ug | Cotadutide 600 ug | Placebo 600 ug | Placebo 300 ug |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 5/17 | 9/18 | 0/9 | 1/10 |
| VomitingGastrointestinal disorders | 5/17 | 6/18 | 0/9 | 0/10 |
| Covid-19Infections and infestations | 1/17 | 5/18 | 0/9 | 0/10 |
| Injection site pruritusGeneral disorders | 0/17 | 0/18 | 2/9 | 0/10 |
| NasopharyngitisInfections and infestations | 0/17 | 4/18 | 0/9 | 0/10 |
| Decreased appetiteMetabolism and nutrition disorders | 3/17 | 4/18 | 0/9 | 0/10 |
| PruritusSkin and subcutaneous tissue disorders | 0/17 | 0/18 | 2/9 | 0/10 |
| Injection site reactionGeneral disorders | 2/17 | 0/18 | 0/9 | 2/10 |
| HeadacheNervous system disorders | 1/17 | 0/18 | 0/9 | 2/10 |
| DiarrhoeaGastrointestinal disorders | 3/17 | 3/18 | 0/9 | 1/10 |
Although there are two placebo arms for blinding purposes, the safety and efficacy analyses in the (abbreviated) CSR pooled the two placebo arms and analyzed them as a single group.
| Age, Continuous(Years) | Cotadutide 300 ug | Cotadutide 600 ug | Placebo 600 ug | Placebo 300 ug | Total |
|---|---|---|---|---|---|
| Mean(standard Deviation) | 54.4 ± 12.4 | 53 ± 12.6 | 56.4 ± 9.4 | 56.9 ± 11.6 | 54.7 ± 11.7 |
| Age, Customized(Participants) | Cotadutide 300 ug | Cotadutide 600 ug | Placebo 600 ug | Placebo 300 ug | Total |
|---|---|---|---|---|---|
| >= 65 years | 4 | 4 | 2 | 3 | 13 |
| >=50 - <65 years | 7 | 7 | 5 | 4 | 23 |
| < 50 years | 6 | 7 | 2 | 3 | 18 |
| Sex: Female, Male(Participants) | Cotadutide 300 ug | Cotadutide 600 ug | Placebo 600 ug | Placebo 300 ug | Total |
|---|---|---|---|---|---|
| Female | 11 | 10 | 6 | 4 | 31 |
| Male | 6 | 8 | 3 | 6 | 23 |
| Race/Ethnicity, Customized(Participants) | Cotadutide 300 ug | Cotadutide 600 ug | Placebo 600 ug | Placebo 300 ug | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 1 | 2 |
| Asian | 5 | 9 | 2 | 2 | 18 |
| Black or African American | 0 | 1 | 0 | 0 | 1 |
| Multiple | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Not Reported | 1 | 0 | 0 | 0 | 1 |
| Other | 0 | 0 | 0 | 0 | 0 |
| White | 11 | 8 | 6 | 7 | 32 |
Showing the first 100 of 115 sites across 20 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease→
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