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NCT04583423 · ClinicalTrials.gov registry record · Phase 2
A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Terminated
- Registry status
- Phase 2
- Development phase
- 183
- Enrollment target
NCT04583423: Clinical Trial Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT04583423 is a Phase 2 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 183 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04583423, a Phase 2 study, was terminated before completion, sponsored by Merck Sharp & Dohme.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 183 participants
- Enrollment target
Study 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.
Primary Outcome
The NASH Clinical Research Network (CRN) scoring system evaluated by Blinded Independent Central Review (BICR) was used to assess treatment response. The NASH CRN scoring scales were: lobular inflammation score (0-3); hepatocyte ballooning score (0-2); steatosis score (0-3); and fibrosis score (0-4). NASH resolution was defined as a score of 0-1 for inflammation, 0 for ballooning, and any grade of steatosis.
Interventions
- DRUG Placebo
- DRUG MK-3655
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2020-11-11 |
| Est. Completion | 2023-04-13 |
| Phase | Phase 2 |
Why NCT04583423 stopped before completion
NCT04583423 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04583423 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04583423 about?
NCT04583423 is a clinical study titled "A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)". 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 ...
What is the current status of trial NCT04583423?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 183 participants. The study started on 2020-11-11. Estimated completion is 2023-04-13.
What interventions are being tested in trial NCT04583423?
The interventions under investigation include: Placebo (DRUG), MK-3655 (DRUG).
Who is sponsoring clinical trial NCT04583423?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04583423's enrollment target sits among peer trials
183 363rd of 2000 higher than 1,638 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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