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A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)
Sponsor: Merck Sharp & Dohme LLC
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
Conditions
Interventions
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