NCT05934292CompletedPhase 1
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of MK-0616 in Participants With Varying Degrees of Renal Impairment
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 5 Jun 2023
- Start date
- 20 Jul 2023
- Primary completion date
- 19 Jan 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- NCT number
- NCT05934292
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 33
- From 20 Jul 2023 to the primary completion date, 19 Jan 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had a functioning renal transplant in the past 5 years and is taking transplant medication
- Has received an anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) small molecule treatment, monoclonal antibody, or short interfering RNA (siRNA) or RNA interference (ie, Inclisiran) within 12 months prior to Screening
- Participants with RI (Panels A, B, and C): Taking medications to treat chronic medical conditions and/or conditions associated with renal disease, if participant has not been on a stable regimen for at least 1 month (other than statins, which require a stable dose for at least 2 months) prior to administration of the initial dose of study intervention, and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 4 hours after administration of study intervention
- Participated in another investigational study within 4 weeks prior to the prestudy (screening) visit
Other illness
- Has a history gastrointestinal disease which might affect food and drug absorption, as determined by the investigator, or has had gastric bypass or similar surgery
- History of cancer (malignancy)
- History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
Other
- History or presence of renal artery stenosis
- Participants in panels A, B and D: Has rapidly fluctuating renal function as determined by historical measurements
- Consumes greater than 3 servings of alcoholic beverages per day
- Consumes excessive amounts, defined as greater than 6 servings of caffeinated beverages per day
Who the study is looking for
- Be in good health with the exception of renal impairment (RI) and hypercholesterolemia for participants in Panels A, B, and C. Participants with RI that have stable, chronic medical or psychiatric conditions, including but not limited to hypertension, hypercholesterolemia, diabetes mellitus, hyper- or hypothyroidism, gout, and chronic anxiety or depression may be included at the discretion of the investigator
- Body Mass Index (BMI) ≥ 18 kg/m\^2 and ≤ 40 kg/m\^2, inclusive
- Be on a stable dose of any statin therapy defined as: no changes to dose or type of statin therapy for at least 2 months prior to Screening and participant anticipates no changes to statin therapy throughout the study until the poststudy visit
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Velocity Clinical Research, Hallandale Beach ( Site 0003) Coordinator of this site? Confirm its status | Hallandale | United States | Unknown status |
| Advanced Pharma CR, LLC ( Site 0001) Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Clinical Pharmacology of Miami ( Site 0005) Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Orlando Clinical Research Center ( Site 0004) Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Genesis Clinical Research, LLC ( Site 0002) Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.