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)
Altimmune, Inc.
1,800 participants
Jul 30, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Pemvidutide SC Injection
Placebo SC Injection
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07795164