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Clinical Trials in the USA / NCT07795164
Recruiting Phase 3

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

NCT07795164 · tracked via the Priya Life Science USA tracker
Sponsor
Altimmune, Inc
Phase
Phase 3
Started
2026-07-30
Last updated
2026-09-23

Condition(s) studied

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Investigational drug(s) / intervention(s)

Pemvidutide →Placebo

Pemvidutide: Pemvidutide SC Injection

Placebo: Placebo SC Injection

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: All subjects: * No significant changes in body weight (±5%) and not participating in a structured weight loss program for the 3 months prior to screening (or since the historical biopsy, if applicable) * Body mass index (BMI) ≥ 25.0 kg/m2; if Asian, BMI ≥ 23.0 kg/m2 * Type 2 diabetes (T2D) or at least 2 components of metabolic syndrome * Subject agrees to have liver biopsy(ies) as required per protocol Cohort 1 - Histologic diagnosis of F2/F3 MASH based on liver biopsy during screening or historical biopsy within 6 months before screening Cohort 2 - Presumed F2/F3 MASH based on noninvasive testing Exclusion Criteria: * Cirrhosis (F4); portal hypertension or hepatic decompensation; acute or chronic liver disease other than MASH; liver function tests (ALT, AST; alkaline phosphatase; total bilirubin; INR; and platelet count) outside of acceptable ranges; positive HBsAg; active hepatitis C * Uncontrolled T2D or clinically significant persistent hyperglycemia

Primary outcome measure(s)

  • Clinical Outcome Event — Baseline through end of study (approximately Month 60)
    Time to first occurrence of any of the following events through the end of the study: Histologic progression to cirrhosis (F4) on liver biopsy; Liver related events; Liver transplantation; or Death due to any cause
  • Histological Response: MASH resolution — Baseline through Week 52
    Proportion of subjects achieving MASH resolution (according to NASH Clinical Research Network \[CRN\] classification) without worsening of fibrosis
  • Histological Response: Fibrosis improvement — Baseline through Week 52
    Proportion of subjects achieving ≥ 1 stage improvement in liver fibrosis according to the NASH CRN fibrosis staging system without worsening of MASH

Trial sites (9)

FacilityCityRegionStatus
Altimmune Clinical Study Site North Little Rock Arkansas Recruiting
Altimmune Clinical Study Site Fountain Valley California Recruiting
Altimmune Clinical Study Site Fresno California Recruiting
Altimmune Clinical Study Site Gardena California Recruiting
Altimmune Clinical Study Site Long Beach California Recruiting
Altimmune Clinical Study Site Miami Florida Recruiting
Altimmune Clinical Study Site Ocala Florida Recruiting
Altimmune Clinical Study Site Springboro Ohio Recruiting
Altimmune Clinical Study Site Westlake Ohio Recruiting

More Altimmune, Inc. trials in the USA

RESTORE TRIAL: Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD) Active, not recruiting

Other trials for the same condition

A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition Recruiting
A Study of VV-14303 for the Treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH) Recruiting
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07795164 on ClinicalTrials.gov ↗ ← All trials in the USA