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Completed

NCT Number: NCT06643377

A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)

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 (PK) study). Researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do not work properly) and to people who are in good health. The researchers believe that the total amount of enlicitide in a person's body measured during the 24 hours after a dose will be similar in people with severe renal impairment and in healthy people.

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Key information

Conditions

Healthy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Impairment Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Velocity Clinical Research, New Smyrna Beach ( Site 0003), Edgewater, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • Body Mass Index (BMI) between 18 and 40 kg/m^2, inclusive
  • On a stable dose of statin therapy; no changes to dose or type of statin therapy for at least 2 months

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • History or presence of renal artery stenosis
  • Had a functioning renal transplant in the past 5 years and is taking transplant medication
  • History of gastrointestinal (GI) disease which might affect food and drug absorption

Panel A: Participants with Severe Renal Impairment:

  • History of any illness, other than hypercholesterolemia and Renal Impairment

Panel B: Healthy Participants:

  • History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases, other than hypercholesterolemia

Treatment and study plan

Enlicitide

Drug

Oral tablet

Other names: Enlicitide decanoate, MK-0616

Primary outcomes

  1. Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma

    Time frame: Pre-dose and at designated time points up to 24 hours post dose on Day 28

    AUC0-24 of enlicitide in plasma will be determined.

  2. Maximum plasma concentration (Cmax) of enlicitide in plasma

    Time frame: Pre-dose and at designated time points up to 24 hours post dose on Day 28

    Cmax of enlicitide in plasma will be determined.

  3. Time to maximum plasma concentration (Tmax) of enlicitide in plasma

    Time frame: Pre-dose and at designated time points up to 24 hours post dose on Day 28

    Tmax of enlicitide in plasma will be determined.

  4. Apparent Clearance (CL/F) of enlicitide in plasma

    Time frame: Pre-dose and at designated time points up to 24 hours post dose on Day 28

    CL/F of enlicitide in plasma will be determined.

  5. Apparent volume of distribution during terminal phase (Vz/F) of enlicitide in plasma

    Time frame: Pre-dose and at designated time points up to 24 hours post dose on Day 28

    Vz/F of enlicitide in plasma will be determined.

  6. Number of participants who experience one or more adverse events (AEs)

    Time frame: Up to approximately 42 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  7. Number of participants who discontinue study intervention due to an AE

    Time frame: Up to approximately 28 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, Multiple-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Severe Renal Impairment

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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