DRUG
Cotadutide
Cotadutide administered subcutaneously once daily
Status
Completed
Phase
Phase 2
Enrollment
54
Locations
115
Results
Posted
Publications
0
Study summary
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.
Interventions
DRUG
Cotadutide administered subcutaneously once daily
DRUG
Placebo administered subcutaneously once daily
Timeline
First posted
May 6, 2022
Study start
Jul 14, 2022
Primary completion
Apr 19, 2024
Study completion
Apr 19, 2024
Results posted
Sep 3, 2025
Registry updated
Sep 3, 2025
Outcomes
Number of Participants With Adverse Events (AEs).
Time frame · First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
To assess safety and tolerability of Cotadutide. Occurrence of AEs and serious AEs, including AEs leading to dose reduction, and AEs of special interest.
Number of Participants With Abnormal Vital Signs.
Time frame · First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
To assess safety and tolerability of Cotadutide.
Number of Participants With Abnormal Laboratory Assessments
Time frame · First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
To assess safety and tolerability of Cotadutide.
Number of Participants With Treatment Emergent Abnormality in 12-lead Electrocardiogram (ECG).
Time frame · First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
To assess safety and tolerability of Cotadutide.
Number of Treatment-induced Anti-Drug Antibody (ADA) Participants
Time frame · First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
To assess the immunogenicity of Cotadutide
Titer of Treatment-induced Anti-Drug Antibody (ADA)
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).
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.
Not reported in the indexed record.
Eligibility
Inclusion Criteria: 1. Provision of informed consent 2. Males and female participants ≥ 18 to ≤ 75 years of age (inclusive) at the time of signing the informed consent. 3. 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: 1. NAS (Non-alcoholic Fatty Liver Disease Activity Score) ≥ 4 with a score of ≥ 1 for each component: steatosis, lobular inflammation, and ballooning 2. Presence of fibrosis stage F2 or F3 4. Women of childbearing potential, non-pregnant and nonbreastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study intervention. Exclusion Criteria: 1. Chronic liver disease of other etiologies. 2. History of cirrhosis and/or hepatic decompensation, including evidence of portal hypertension (e.g. low platelet count, splenomegaly, ascites, history of hepatic encephalopathy, esophageal varices, or variceal bleeding). 3. Clinically significant cardiovascular or cerebrovascular disease within 90 days prior to screening, including but not limited to, myocardial infarction, acute coronary syndrome, unstable angina pectoris, transient ischemic attack, or stroke, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 90 days or who are due to undergo these procedures at the time of screening 4. History of malignant neoplasms within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or any in situ carcinoma. 5. Participation in another clinical study with an investigational product administered within the last 30 days or 5 half-lives of the therapy (whichever is longer) at the time of screening or the time of the historical biopsy or concurrent participation in another interventional study of any kind or prior randomization in this study. 6. Severe allergy/hypersensitivity to any of the proposed study treatments or excipients 7. Contraindication to liver biopsy (eg, bleeding diathesis, such as hemophilia, suspected hemangioma, or suspected echinococcal infection) or inability to safely obtain a liver biopsy as determined by the investigator 8. Severely uncontrolled hypertension defined as SBP ≥ 180 mmHg or DBP ≥ 110 mmHg on the average of 2 seated BP measurements after being at rest for at least 10 minutes at screening or randomization 9 Any positive results for human immunodeficiency virus infection, positive results for hepatitis B surface antigen or hepatitis C antibody test along with a positive HCV RNA test.
Study locations
Argentina · Australia · Austria · Canada · France · Germany · Greece · Israel · Italy · Japan · Malaysia · New Zealand · South Africa · South Korea · Spain · Taiwan · Thailand · Turkey (Türkiye) · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Research Site
Tucson, Arizona, United States
Research Site
Canoga Park, California, United States
Research Site
Gilroy, California, United States
Research Site
Sacramento, California, United States
Research Site
Englewood, Colorado, United States
Research Site
Bradenton, Florida, United States
Research Site
Homestead, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Munster, Indiana, United States
Research Site
Houma, Louisiana, United States
Research Site
Marrero, Louisiana, United States
Research Site
Marrero, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Lawrence, New Jersey, United States
Research Site
Warren Township, New Jersey, United States
Research Site
Morehead City, North Carolina, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Arlington, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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