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RecruitingPhase 3

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

Altimmune, Inc. · NCT07795164

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
1800
US sites recruiting
9
Study start
July 30, 2026
Record last updated
September 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Pemvidutide; Placebo

Conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

Study contacts (from the official record)

  • Shaheen Tomah, MD · 240-235-0145 · performa@altimmune.com
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Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of… (NCT07795164) | Bored Studies