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

NCT06575959 | Completed Phase 1 Results 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 (2)

• Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of Enlicitide

  Blood samples were collected at pre-specified time points to determine the AUC0-inf of enlicitide in plasma. AUC0-inf was defined as AUC0-last + (Cest,last/λz) where Cest, last was the estimated last measurable concentration, and λz was the apparent first-order terminal elimination rate constant.

  Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose

• Maximum Concentration (Cmax) of Enlicitide

  Blood samples were collected at pre-specified time points to determine the Cmax of enlicitide in participant's plasma. Cmax was defined as the maximum observed concentration of enlicitide in plasma after the administration of a given dose.

  Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose

Secondary Outcomes (9)

• Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Enlicitide

  Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, and 24 hours postdose

• Area Under the Concentration Versus Time Curve From Time 0 to Last (AUC0-last) of Enlicitide in Plasma

  Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose

• Time to Maximum (Tmax) Observed Plasma Drug Concentration of Enlicitide

  Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose

• Apparent Terminal Half-life (t1/2) of Enlicitide

  Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose

• Apparent Clearance (CL/F) of Enlicitide

  Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose

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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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 29, 2026
• Results First Posted: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)