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Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH
Sponsor: Altimmune, Inc.
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1800
Start Date
2026-07-30
Completion Date
2032-12
Last Updated
2026-09-23
Healthy Volunteers
No
Interventions
Pemvidutide
Pemvidutide SC Injection
Placebo
Placebo SC Injection
Locations (9)
Altimmune Clinical Study Site
North Little Rock, Arkansas, United States
Altimmune Clinical Study Site
Fountain Valley, California, United States
Altimmune Clinical Study Site
Fresno, California, United States
Altimmune Clinical Study Site
Gardena, California, United States
Altimmune Clinical Study Site
Long Beach, California, United States
Altimmune Clinical Study Site
Miami, Florida, United States
Altimmune Clinical Study Site
Ocala, Florida, United States
Altimmune Clinical Study Site
Springboro, Ohio, United States
Altimmune Clinical Study Site
Westlake, Ohio, United States