A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)

Part of paid clinical trials in Miami, Florida.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06052566
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Efinopegdutide — DRUG
    Subcutaneous injection administered at a dose of 7 mg

Study Details

The purpose of this study was to evaluate the pharmacokinetics of efinopegdutide in participants with hepatic impairment compared to healthy participants, and to examine the safety and tolerability of efinopegdutide.

Key Dates

Start date
Nov 21, 2023
Status verified
Oct 2025
Primary completion
Dec 5, 2024
Completion
Dec 5, 2024

Study Design

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

Arms

  • Experimental: Efinopegdutide in Participants with Moderate Hepatic Impairment
    Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.
  • Experimental: Efinopegdutide in Participants with Severe Hepatic Impairment
    Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
  • Experimental: Efinopegdutide in Healthy-Matched Control Group
    Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.

Primary Outcome Measure

Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide [ Time Frame: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Advanced Pharma CR, LLC ( Site 0001)MiamiFlorida33147-
Clinical Pharmacology of Miami ( Site 0005)MiamiFlorida33014-3616-
Genesis Clinical Research, LLC ( Site 0006)TampaFlorida33603-
American Research Corporation ( Site 0002)San AntonioTexas78215-

Find similar trials in Miami, FL

By research site
Advanced Pharma CR, LLC· Miami, FLClinical Pharmacology of Miami· Miami, FLGenesis Clinical Research, LLC· Tampa, FLAmerican Research Corporation· San Antonio, TX

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