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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Renal Impairment; Healthy

Treatments: Drug: Enlicitide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06643377

0616-032

MK-0616-032 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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 for at least 2 months

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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Panel A: Severe Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: Enlicitide

Panel B: Healthy

Experimental group

Description:

Healthy participants receive enlicitide QD for 28 days.

Treatment:

Drug: Enlicitide