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Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
NCT05934292 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05934292
The ClinicalTrials.gov registry entry for NCT05934292 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05934292 reports 5 study locations spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05934292?
The interventions under investigation include: Enlicitide Decanoate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05934292?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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