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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06575959
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment
  • Hepatic Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Enlicitide — DRUG
    Oral tablet

Study Details

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.

Key Dates

Start date
Sep 20, 2024
Status verified
May 2026
Primary completion
May 1, 2025
Completion
May 8, 2025

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Moderate Hepatic Impairment (HI)
    Participants will receive a single oral dose of enlicitide on Day 1
  • Experimental: Healthy Controls
    Participants will receive a single oral dose of enlicitide on Day 1
  • Experimental: Mild HI
    Participants will receive a single oral dose of enlicitide on Day 1

Primary Outcome Measure

Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of Enlicitide [ Time Frame: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose ]

Locations (2)

FacilityCityStateZIPSite coordinators
Orlando Clinical Research Center ( Site 0002)OrlandoFlorida32809-
The Texas Liver Institute ( Site 0001)San AntonioTexas78215-

Find similar trials in Orlando, FL

By research site
Orlando Clinical Research Center· Orlando, FLThe Texas Liver Institute· San Antonio, TX

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