RecruitingPhase 3NCT07795164

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)


Sponsor

Altimmune, Inc.

Enrollment

1,800 participants

Start Date

Jul 30, 2026

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Pemvidutide and Placebo for people with metabolic dysfunction-associated steatohepatitis (mash). The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years to 75 Years.

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

DRUGPemvidutide

Pemvidutide SC Injection

OTHERPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT07795164


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