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 - PROXYMO-ADV

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.