No significant changes in body weight (±5%) and not participating in a structured weight loss program for the 3 months prior to screening (or since the historical biopsy, if applicable)
Body mass index (BMI) ≥ 25.0 kg/m2; if Asian, BMI ≥ 23.0 kg/m2
Type 2 diabetes (T2D) or at least 2 components of metabolic syndrome
Subject agrees to have liver biopsy(ies) as required per protocol
Cohort 1 - Histologic diagnosis of F2/F3 MASH based on liver biopsy during screening or historical biopsy within 6 months before screening
Cohort 2 - Presumed F2/F3 MASH based on noninvasive testing
You may not be if
Cirrhosis (F4); portal hypertension or hepatic decompensation; acute or chronic liver disease other than MASH; liver function tests (ALT, AST; alkaline phosphatase; total bilirubin; INR; and platelet count) outside of acceptable ranges; positive HBsAg; active hepatitis C
Uncontrolled T2D or clinically significant persistent hyperglycemia
Clareo Health | Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH
