Study S001870

A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Precirrhotic Nonalcoholic Steatohepatitis

ClinicalTrials.gov record

Registration

Registration: NCT05877547
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: TRIPLE
Status: COMPLETED
Enrollment: 381
Start: 2023-06-23
Primary completion: 2025-12-29
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Non-alcoholic Fatty Liver Disease; Fatty Liver, Nonalcoholic; NAFLD; Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
Interventions: DRUG:Efinopegdutide; DRUG:Semaglutide; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: REGISTRY:2022-502647-35-00; OTHER:MK-6024-013; REGISTRY:jRCT2031230187; REGISTRY:U1111-1285-0933

Registered primary outcomes

Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52 [Week 52]
Percentage of Participants Who Experienced an Adverse Event (AE) [Up to 60 weeks]
Percentage of Participants Discontinuing Study Medication Due to an AE [Up to 52 weeks]

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.