Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH
Eligible age
18–75 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
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About this study
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.
Sponsor: Altimmune, Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
North Little Rock
Fountain Valley · Fresno · Gardena · Long Beach
Miami · Ocala
Springboro · Westlake
Source: ClinicalTrials.gov · NCT07795164 · last updated 2026-09-23