A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Hepatic Insufficiency

Treatments: Drug: Enlicitide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06575959

MK-0616-030 (Other Identifier)

0616-030

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 or PK study). Researchers will compare what happens to enlicitide in the body when it is given to people with hepatic impairment (HI- meaning the liver does not work properly) and people who are in good health.

This study will have 2 parts. In Part 1, enlicitide will be given to people with moderate HI and people who are in good health. After Part 1, researchers may decide to include people who have mild HI and compare what happens to enlicitide in the body with people who are in good health.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

All participants:

• Has been a non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to starting the study
• Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m2

Participants with moderate or mild HI:

• Diagnosis of chronic (> 6 months) and stable (no sudden or severe episodes of illness due to worsening liver function in the past 2 months) hepatic insufficiency, and features cirrhosis (liver scarring) due to any cause.
• Is generally in good health with the exception of HI.

Healthy Control Participants:

• Medically healthy with no clinically significant medical history, physical examination, or clinical laboratory profiles

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

All participants:

• History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery.
• History of cancer
• Consumes greater than 3 servings of alcoholic beverages per day.
• Is on statin background therapy.

Participants with moderate or mild HI:

• Severe complications of liver disease within 3 months of entering the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Moderate Hepatic Impairment (HI)

Experimental group

Description:

Participants will receive a single oral dose of enlicitide on Day 1

Treatment:

Drug: Enlicitide

Healthy Controls

Experimental group

Description:

Participants will receive a single oral dose of enlicitide on Day 1

Treatment:

Drug: Enlicitide

Mild HI

Experimental group

Description:

Participants will receive a single oral dose of enlicitide on Day 1

Treatment:

Drug: Enlicitide