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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

Edgewater

Velocity Clinical Research, New Smyrna Beach ( Site 0003), Edgewater, Florida, United States, 32132

Hallandale Beach

Velocity Clinical Research, Hallandale Beach ( Site 0006), Hallandale Beach, Florida, United States, 33009

Jacksonville

Jacksonville Center for Clinical Research ( Site 0004), Jacksonville, Florida, United States, 32216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2025-05-08