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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-20

Study Completion Date

2025-05-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intralumenal Effects on Cholesterol Absorption/Synthesis

NCT00328211

Healthy

COMPLETED NA

GlycoCholic Acid Treatment for Patients With Inborn Errors in Bile Acid Synthesis

NCT01589523

Bile Acid Synthesis Defect Inborn Error of Bile Acid Metabolism Inborn Error of Bile Acid Conjugation

COMPLETED PHASE3

Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis

NCT01865812

Primary Biliary Cirrhosis

COMPLETED PHASE2

Dietary Allowance of Methyl Donor Nutrients to Minimize Risks of Non-alcoholic Fatty Liver Progression

NCT05291104

Non-alcoholic Fatty Liver Disease

UNKNOWN NA

Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects

NCT04053023

Cholestasis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatic Insufficiency Hepatic Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Moderate Hepatic Impairment (HI)

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

Group Type EXPERIMENTAL

Enlicitide

Intervention Type DRUG

Oral tablet

Healthy Controls

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

Group Type EXPERIMENTAL

Enlicitide

Intervention Type DRUG

Oral tablet

Mild HI

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

Group Type EXPERIMENTAL

Enlicitide

Intervention Type DRUG

Oral tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Enlicitide

Oral tablet

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

enlicitide decanoate MK-0616/sodium caprate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes