EUCTR2021-005484-53-ATActive, not recruitingPhase 1
A Phase II Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Cotadutide in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis with Fibrosis - PROXYMO-ADVANCE
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 55
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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:
- •(a)NAS (Non-alcoholic Fatty Liver Disease Activity Score) = 4 with a score of = 1 for each component: steatosis, lobular inflammation, and ballooning
- •(b)Presence of fibrosis stage F2 or F3
- •4.Women of childbearing potential, non-pregnant and non-breastfeeding using at least one highly effective method of birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study intervention.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
- •1Chronic liver disease of other etiologies.
- •2History 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).
- •3Clinically 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
- •4History of malignant neoplasms within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or any in situ carcinoma.
- •5Participation 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.
- •6Severe allergy/hypersensitivity to any of the proposed study treatments or excipients
- •7Contraindication 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
- •8Severely 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
- •9Any 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.
Investigators
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