clinical trial · NCT07795164
Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH
Metabolic Dysfunction-Associated Steatohepatitis (MASH)PemvidutidePlacebo
brief 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.
started
Jul 30, 2026
primary completion
Dec 1, 2028
completion
Dec 1, 2032
last updated
Sep 23, 2026
official title
A Phase 3, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in Subjects With Noncirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol