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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-22

Study Completion Date

2025-06-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Panel A: Severe Renal Impairment

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

Group Type EXPERIMENTAL

Enlicitide

Intervention Type DRUG

Oral tablet

Panel B: Healthy

Healthy participants receive enlicitide QD for 28 days.

Group Type EXPERIMENTAL

Enlicitide

Intervention Type DRUG

Oral tablet

Interventions

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Enlicitide

Oral tablet

Intervention Type DRUG

Other Intervention Names

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Enlicitide decanoate MK-0616

Eligibility Criteria

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Inclusion 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes