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

Phase

Condition

Nephropathy

Focal Segmental Glomerulosclerosis

Kidney Failure (Pediatric)

Treatment

Enlicitide

Clinical Study ID

NCT06643377

0616-032

MK-0616-032

Ages 18-85
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 forat least 2 months

Exclusion

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 transplantmedication
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

Study Design

Enlicitide

November 22, 2024

June 25, 2025

Connect with a study center

Velocity Clinical Research, New Smyrna Beach ( Site 0003)
Edgewater, Florida 32132
United States
Site Not Available
Velocity Clinical Research, Hallandale Beach ( Site 0006)
Hallandale, Florida 33009
United States
Site Not Available
Nature Coast Clinical Research - Inverness ( Site 0002)
Inverness, Florida 34452
United States
Site Not Available
Jacksonville Center for Clinical Research ( Site 0004)
Jacksonville, Florida 32216
United States
Site Not Available
Genesis Clinical Research, LLC ( Site 0001)
Tampa, Florida 33603
United States
Site Not Available

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