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

NCT07795164 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2026-08-31

No results posted yet for this study

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.

Conditions

  • Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Interventions

DRUG

Pemvidutide

Pemvidutide SC Injection

OTHER

Placebo

Placebo SC Injection

Sponsors & Collaborators

  • Altimmune, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-30
Primary Completion
2028-12-31
Completion
2032-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07795164 on ClinicalTrials.gov