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NCT05934292 · ClinicalTrials.gov registry record · Phase 1
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
A Phase 1 study of Hypercholesterolaemia, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 5
- Study locations
NCT05934292: Completed Phase 1 study of Hypercholesterolaemia, sponsored by Merck Sharp & Dohme.
NCT05934292 is a Phase 1 study of Hypercholesterolaemia that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 33 participants, below the 5,045-participant average among 3 other Hypercholesterolaemia trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05934292, a Phase 1 study of Hypercholesterolaemia, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 5
- Study locations
Study Summary
The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment (moderate, severe, end stage renal disease \[ESRD\]) to those of healthy mean matched control participants on a background of statin therapy. There is no formal hypothesis.
Primary Outcome
AUC0-inf was a measure of the total amount of drug in the plasma from the dose administration extrapolated to infinity. Blood for plasma samples was collected at pre-specified timepoints to determine the AUC0-inf of enlicitide decanoate for Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C ESRD - enlicitide decanoate pre-hemodialysis and Panel C ESRD - enlicitide decanoate post-hemodialysis to report AUC0-inf. Per protocol, mean AUC0-inf
Conditions Studied
Interventions
- DRUG Enlicitide Decanoate
Study Locations (5)
Florida
- Velocity Clinical Research, Hallandale Beach ( Site 0003) - Hallandale
- Clinical Pharmacology of Miami ( Site 0005) - Miami
- Advanced Pharma CR, LLC ( Site 0001) - Miami
- Orlando Clinical Research Center ( Site 0004) - Orlando
- Genesis Clinical Research, LLC ( Site 0002) - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2023-07-20 |
| Est. Completion | 2024-01-19 |
| Phase | Phase 1 |
What the finished NCT05934292 record still lists
NCT05934292 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 5,045-participant average among 3 other Hypercholesterolaemia trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Hypercholesterolaemia appearing as the primary indexed condition, and to 1 intervention - of which Enlicitide Decanoate is the first listed.
NCT05934292 lists 5 locations in 1 state (Florida).
Frequently Asked Questions
What is clinical trial NCT05934292 about?
NCT05934292 is a clinical study titled "Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)". The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment (moderate, severe, end stage renal disease \[ESRD\]) to those of healthy ...
What is the current status of trial NCT05934292?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2023-07-20. Estimated completion is 2024-01-19.
What conditions does trial NCT05934292 study?
This clinical trial studies the following conditions: Hypercholesterolaemia.
What interventions are being tested in trial NCT05934292?
The interventions under investigation include: Enlicitide Decanoate (DRUG).
Who is sponsoring clinical trial NCT05934292?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05934292 being conducted?
This trial has 5 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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