A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)

Part of paid clinical trials in Edgewater, Florida.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06643377
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 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 (PK) study). Researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do not work properly) and to people who are in good health. The researchers believe that the total amount of enlicitide in a person's body measured during the 24 hours after a dose will be similar in people with severe renal impairment and in healthy people.

Key Dates

Start date
Nov 22, 2024
Status verified
Jul 2025
Primary completion
Jun 25, 2025
Completion
Jun 25, 2025

Study Design

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

Arms

  • Experimental: Panel A: Severe Renal Impairment
    Participants with severe renal impairment receive enlicitide once daily (QD) for 28 days.
  • Experimental: Panel B: Healthy
    Healthy participants receive enlicitide QD for 28 days.

Primary Outcome Measure

Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma [ Time Frame: Pre-dose and at designated time points up to 24 hours post dose on Day 28 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Velocity Clinical Research, New Smyrna Beach ( Site 0003)EdgewaterFlorida32132-
Velocity Clinical Research, Hallandale Beach ( Site 0006)HallandaleFlorida33009-
Nature Coast Clinical Research - Inverness ( Site 0002)InvernessFlorida34452-
Jacksonville Center for Clinical Research ( Site 0004)JacksonvilleFlorida32216-
Genesis Clinical Research, LLC ( Site 0001)TampaFlorida33603-

Find similar trials in Edgewater, FL

By research site
Velocity Clinical Research, New Smyrna Beach· Edgewater, FLVelocity Clinical Research, Hallandale Beach· Hallandale, FLNature Coast Clinical Research - Inverness· Inverness, FLJacksonville Center for Clinical Research· Jacksonville, FLGenesis Clinical Research, LLC· Tampa, FL

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