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

NCT07795164 · Recruiting

Last updated 2026-09-22

This clinical trial is testing the drug pemvidutide in adults with Metabolic Dysfunction-Associated Steatohepatitis (MASH) to evaluate its safety and effects on disease-related outcomes.

Status Recruiting Currently enrolling participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 1,800 people Planned (estimated).

Who can join Ages 18–75 · all sexes

Timeline Started 2026-07 · est. completion 2032-12

Where 9 sites · United States

What this study is testing ClinicalTrials.gov NCT07795164 ↗

Description as written by the study sponsor.

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.

Treatments tested

Pemvidutide Drug

Pemvidutide SC Injection
Placebo Other

Placebo SC Injection

Main thing measured	Clinical Outcome Event
Sponsor	Altimmune, Inc.
Conditions studied	Metabolic Dysfunction-Associated Steatohepatitis (MASH)
GLP-1 drugs	pemvidutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07795164 ↗