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COMPLETED
NCT06643377
PHASE1

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2024-11-22

Completion Date

2025-06-25

Last Updated

2026-10-20

Healthy Volunteers

Yes

Interventions

DRUG

Enlicitide

Oral tablet

Locations (5)

Velocity Clinical Research, New Smyrna Beach ( Site 0003)

Edgewater, Florida, United States

Velocity Clinical Research, Hallandale Beach ( Site 0006)

Hallandale, Florida, United States

Nature Coast Clinical Research - Inverness ( Site 0002)

Inverness, Florida, United States

Jacksonville Center for Clinical Research ( Site 0004)

Jacksonville, Florida, United States

Genesis Clinical Research, LLC ( Site 0001)

Tampa, Florida, United States