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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Altimmune, Inc. • ClinicalTrials.gov ID: NCT07795164

Registry updated: 2026-09-23
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Description

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.

Interventions

  • Pemvidutide (Drug)
    Pemvidutide SC Injection
  • Placebo (Other)
    Placebo SC Injection

Eligibility criteria

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

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record