Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH
In plain words A Phase 3 study of pemvidutide in people 18 to 75, run by Altimmune, Inc.. It plans to enroll about 1,800 people at 9 US sites.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 75. Conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH).
- 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
The exclusion criteria are on the listing.
What it tests, as registered
Pemvidutide; Placebo
Registered 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.
Where, as registered
9 US sites in 4 states.