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

NCT06643377 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0616-032MK-0616-032
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 5

Brief 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 (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.

Conditions

Healthy; Renal Impairment

Outcome Measures

Primary Outcomes (7)

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

  AUC0-24 of enlicitide in plasma will be determined.

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

• Maximum plasma concentration (Cmax) of enlicitide in plasma

  Cmax of enlicitide in plasma will be determined.

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

• Time to maximum plasma concentration (Tmax) of enlicitide in plasma

  Tmax of enlicitide in plasma will be determined.

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

• Apparent Clearance (CL/F) of enlicitide in plasma

  CL/F of enlicitide in plasma will be determined.

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

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

  Vz/F of enlicitide in plasma will be determined.

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

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

  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.

  Up to approximately 42 days

• Number of participants who discontinue study intervention due to an AE

  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.

  Up to approximately 28 days

Study Arms (2)

Panel A: Severe Renal Impairment

EXPERIMENTAL

Participants with severe renal impairment receive enlicitide once daily (QD) for 28 days.

Drug: Enlicitide

Panel B: Healthy

EXPERIMENTAL

Healthy participants receive enlicitide QD for 28 days.

Drug: Enlicitide

Interventions

Enlicitide DRUG

Oral tablet

Also known as: Enlicitide decanoate, MK-0616

Panel A: Severe Renal Impairment; Panel B: Healthy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (5)

Velocity Clinical Research, New Smyrna Beach ( Site 0003)

Edgewater, Florida, 32132, United States

Location

Velocity Clinical Research, Hallandale Beach ( Site 0006)

Hallandale, Florida, 33009, United States

Location

Nature Coast Clinical Research - Inverness ( Site 0002)

Inverness, Florida, 34452, United States

Location

Jacksonville Center for Clinical Research ( Site 0004)

Jacksonville, Florida, 32216, United States

Location

Genesis Clinical Research, LLC ( Site 0001)

Tampa, Florida, 33603, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Renal Insufficiency

Interventions

MK-0616

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: November 22, 2024
• Primary Completion: June 25, 2025
• Study Completion: June 25, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (5)