Study S000929

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)

ClinicalTrials.gov record

Registration

Registration: NCT07795164
Acronym: PERFORMA
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: RECRUITING
Enrollment: 1800
Start: 2026-07-30
Primary completion: 2028-12
Lead sponsor: Altimmune, Inc.
Conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Interventions: DRUG:Pemvidutide; OTHER:Placebo
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

Clinical Outcome Event [Baseline through end of study (approximately Month 60)]
Histological Response: MASH resolution [Baseline through Week 52]
Histological Response: Fibrosis improvement [Baseline through Week 52]

Linked records (0)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

No records link to this registration yet.