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

RecruitingPhase 3Ages 18 Years - 75 YearsAllAltimmune, Inc.
NCT07795164 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Pemvidutide
  • Placebo
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Where

9 sites
Altimmune Clinical Study Site
North Little Rock, United States
Altimmune Clinical Study Site
Fountain Valley, United States
Altimmune Clinical Study Site
Fresno, United States
Altimmune Clinical Study Site
Gardena, United States
Altimmune Clinical Study Site
Long Beach, United States
Altimmune Clinical Study Site
Miami, United States
Altimmune Clinical Study Site
Ocala, United States
Altimmune Clinical Study Site
Springboro, United States

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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