A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-fibrosis)
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease(MASH) / Nonalcoholic Steatohepatitis (NASH) With FibrosisMedDRA version: 25.0Level: LLTClassification code: 10086498Term: Metabolic associated fatty liver disease Class: 100000004848MedDRA version: 25.0Level: LLTClassification code: 10082249Term: Nonalcoholic fatty liver disease Class: 100000004871Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2023-509912-27-00
- Lead Sponsor
- 89bio Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1050
1_Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF), 2_Biopsy-confirmed MASH with fibrosis stage F2 or F3 per NASH CRN System and NAS >=4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation (qualifying biopsy must be either within 6 months of screening visit ,with additional requirements, or obtained during screening period), 3_Body mass index (BMI) at Screening >=25.0 (>=23 for Asian subjects) and <50.0 kg/m2
1_Chronic liver diseases other than MASH/NASH, 2_History or evidence of cirrhosis, 3_Have type 1 diabetes or poorly controlled type 2 diabetes, 4_Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=250 U/L, Subjects taking vitamin E (>400 IU/day) must be on stable dose for at least 6 months prior to screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method