Trials / Terminated
TerminatedNCT04583423
A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)
A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 183 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks. The primary hypothesis of the study is that at least 1 dose of MK-3655 is superior to placebo with respect to the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MK-3655 | MK-3655 50, 100 or 300 dose for injection |
| DRUG | Placebo | Matching placebo to MK-3655 |
Timeline
- Start date
- 2020-11-11
- Primary completion
- 2023-04-13
- Completion
- 2023-04-13
- First posted
- 2020-10-12
- Last updated
- 2025-07-17
- Results posted
- 2024-04-29
Locations
180 sites across 24 countries: United States, Argentina, Australia, Canada, Chile, China, Colombia, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Puerto Rico, Russia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04583423. Inclusion in this directory is not an endorsement.