A Study to Evaluate the Safety and Efficacy of Cotadutide Given by Subcutaneous Injection in Adult Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

In brief

The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.

Key facts

Study ID

NCT05364931

Run by

AstraZeneca

People needed

54

Starts

2022-07-14

Expected to finish

2024-04-19

Last updated by the study team

2025-09-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of informed consent
• Males and female participants ≥ 18 to ≤ 75 years of age (inclusive) at the time of signing the informed consent.
• 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:
• NAS (Non-alcoholic Fatty Liver Disease Activity Score) ≥ 4 with a score of ≥ 1 for each component: steatosis, lobular inflammation, and ballooning
• Presence of fibrosis stage F2 or F3
• 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.

You may not qualify if…

• Chronic liver disease of other etiologies.
• 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).
• 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
• 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.
• 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.
• Severe allergy/hypersensitivity to any of the proposed study treatments or excipients
• 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
• 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.

Where it is running

• Research Site — Konstanz, Germany
• Research Site — Athens, Greece
• Research Site — Ioannina, Greece
• 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 — Dresden, Germany

Full record on ClinicalTrials.gov

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