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

Summary

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.

Timeline

Start

2026-07-30

Primary completion

2028-12

Completion

2032-12

Drugs

Indications