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NCT06575959 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT06575959: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT06575959 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06575959, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward, The purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to enlicitide in the body when it is given to people with hepatic impairment (HI- meaning the liver does not work properly) and people who are in good health. This study will have 2 parts. In Part 1, enlicitide will be given to people with moderate HI and people who are in good health. After Part 1, researchers may decide to include people who have mild HI and compare what happens to enlicitide in the body with people who are in good health.
Primary Outcome
Blood samples were collected at pre-specified time points to determine the AUC0-inf of enlicitide in plasma. AUC0-inf was defined as AUC0-last + (Cest,last/λz) where Cest, last was the estimated last measurable concentration, and λz was the apparent first-order terminal elimination rate constant.
Interventions
- DRUG Enlicitide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-09-20 |
| Est. Completion | 2025-05-08 |
| Phase | Phase 1 |
What the finished NCT06575959 record still lists
NCT06575959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Enlicitide is the first listed.
NCT06575959 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06575959 about?
NCT06575959 is a clinical study titled "A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)". Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward, The purpose of this study is to learn what happen...
What is the current status of trial NCT06575959?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-09-20. Estimated completion is 2025-05-08.
What interventions are being tested in trial NCT06575959?
The interventions under investigation include: Enlicitide (DRUG).
Who is sponsoring clinical trial NCT06575959?
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 NCT06575959's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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