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

NCT06575959 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0616-030MK-0616-030
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Hepatic Insufficiency; Hepatic Impairment

Outcome Measures

Primary Outcomes (4)

• Part 1: Area under the concentration versus time curve from 0 to infinity (AUC0-inf)AUC0-inf of enlicitide

  AUC0-inf of enlicitide in plasma will be determined.

  Pre-dose and at designated time points up to 168 hours post dose

• Part 1: Maximum concentration (Cmax) of enlicitide

  Cmax of enlicitide in plasma will be determined

  Predose, and at designated timepoints up to 168 hours post-dose

• Part 2: AUC 0-inf of enlicitide

  AUC 0-inf of enlicitide in plasma will be determined

  Pre-dose and at designated timepoints up to 168 hours post dose

• Part 2: Cmax of enlicitide

  Cmax of enlicitide in plasma will be determined

  Predose, and at designated timepoints up to 168 hours post-dose

Secondary Outcomes (16)

• Part 1: Area under the concentration versus time curve from 0 to 24 hours (AUC0-24) of enlicitide

  Pre-dose and at designated timepoints up to 168 hours post dose

• Part 1: Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of enlicitide

  Pre-dose and at designated timepoints up to 168 hours post dose

• Part 1: Time to maximum (Tmax) observed plasma drug concentration of enlicitide

  Pre-dose and at designated timepoints up to 168 hours post dose

• Part 1: Apparent terminal half-life (t1/2) of enlicitide

  Pre-dose and at designated timepoints up to 168 hours post dose

• Part 1: Apparent clearance (CL/F) of enlicitide

  Pre-dose and at designated timepoints up to 168 hours post dose

Study Arms (3)

Moderate Hepatic Impairment (HI)

EXPERIMENTAL

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

Drug: Enlicitide

Healthy Controls

EXPERIMENTAL

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

Drug: Enlicitide

Mild HI

EXPERIMENTAL

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

Drug: Enlicitide

Interventions

Enlicitide DRUG

Oral tablet

Also known as: enlicitide decanoate, MK-0616/sodium caprate

Healthy Controls; Mild HI; Moderate Hepatic Impairment (HI)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (2)

Orlando Clinical Research Center ( Site 0002)

Orlando, Florida, 32809, United States

Location

The Texas Liver Institute ( Site 0001)

San Antonio, Texas, 78215, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Hepatic Insufficiency

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: September 20, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 8, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)