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NCT05261126 · ClinicalTrials.gov registry record · Phase 2
A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 381
- Enrollment target
NCT05261126: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT05261126 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 381 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (186% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05261126, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 381 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of enclitide chloride, an oral PCSK9 inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia. The primary hypothesis is that at least one of the four doses of enclitide chloride tested in this study is superior to placebo on percent change from baseline in LDL-C at Week 8.
Primary Outcome
Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in LDL-C. Based on a constrained longitudinal analysis (cLDA) model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in LDL-C at week 8 was reported.
Interventions
- DRUG Placebo
- DRUG Enclitide Chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 381 participants |
| Start Date | 2022-03-10 |
| Est. Completion | 2022-11-28 |
| Phase | Phase 2 |
What the finished NCT05261126 record still lists
NCT05261126 is an interventional study that assigns participants to a tested intervention. The registered 381 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 (186% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05261126 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05261126 about?
NCT05261126 is a clinical study titled "A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)". The purpose of this study is to evaluate the efficacy and safety of enclitide chloride, an oral PCSK9 inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia. The primary hypothesis is that at least one of the four doses of enclitide chloride test...
What is the current status of trial NCT05261126?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 381 participants. The study started on 2022-03-10. Estimated completion is 2022-11-28.
What interventions are being tested in trial NCT05261126?
The interventions under investigation include: Placebo (DRUG), Enclitide Chloride (DRUG).
Who is sponsoring clinical trial NCT05261126?
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 NCT05261126's enrollment target sits among peer trials
381 111th of 2000 higher than 1,890 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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