Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH

A Phase 3, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in Subjects With Noncirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Phase 3, multicenter, multinational, 2-cohort, randomized, double-blind, placebo controlled, parallel-group pivotal study to evaluate the efficacy, safety, and clinical outcomes of pemvidutide treatment in subjects with noncirrhotic (F2 or F3) metabolic dysfunction-associated steatohepatitis (MASH). Participants will be assigned either to Cohort 1 based on screening histologic (liver biopsy) criteria or to Cohort 2 based on non-invasive test criteria.

Inclusion Criteria:

All subjects:

• 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

Exclusion Criteria:

• 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