Trials / Completed
CompletedNCT05877547
A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 381 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH). Researchers will also learn about the safety and benefit of efinopegdutide and how well people tolerate the medicine. The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.
Conditions
- Non-alcoholic Fatty Liver Disease
- Fatty Liver, Nonalcoholic
- NAFLD
- Nonalcoholic Fatty Liver Disease
- Nonalcoholic Steatohepatitis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Efinopegdutide | Subcutaneous (SC) injection in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg |
| DRUG | Semaglutide | SC injection in a dose-escalation regimen of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg |
| DRUG | Placebo | SC injection of matching placebo |
Timeline
- Start date
- 2023-06-23
- Primary completion
- 2025-12-29
- Completion
- 2025-12-29
- First posted
- 2023-05-26
- Last updated
- 2026-01-12
Locations
175 sites across 26 countries: United States, Austria, Belgium, Canada, Chile, China, Colombia, Czechia, France, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Peru, Portugal, Puerto Rico, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05877547. Inclusion in this directory is not an endorsement.