A Study of Efinopegdutide in Healthy Obese Participants (MK-6024-015)

Part of paid clinical trials in South Miami, Florida.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06701305
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Efinopegdutide — DRUG
    Subcutaneous injectable solution
  • Placebo — DRUG
    Subcutaneous injectable solution
  • Acetaminophen — DRUG
    Oral solution

Study Details

The goal of this study is to learn about the safety of efinopegdutide (MK-6024) and how well overweight healthy people tolerate it. Researchers also want to know what happens to efinopegdutide in a person's body over time when taken as a single dose (Part 1) or as multiple doses (Part 2). In addition, the study will assess the amount of acetaminophen in the blood after receiving different strength doses of efinopegdutide (Part 2 only).

Key Dates

Start date
Jun 13, 2024
Status verified
Feb 2025
Primary completion
Feb 18, 2025
Completion
Feb 18, 2025

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part 1: Efinopegdutide
    Part 1: Participants receive a single subcutaneous (SC) dose of efinopegdutide.
  • Placebo Comparator: Part 1: Placebo
    Part 1: Participants receive a single SC dose of placebo.
  • Experimental: Part 2: Efinopegdutide
    Part 2: Participants receive multiple SC doses of efinopegdutide titrated from Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, or Dosage 6. Participants receive a SC dose of efinopegdutide, Dosage 1 on Days 1 and 8; Dosage 2 on Days 15 and 22; Dosage 3 on Days 29, 36, 43 and 50; Dosage 4 on Days 57, 64, 71 and 78; Dosage 5 on Days 85, 92, 99, 106; and Dosage 6 on Days 113, 120, 127, and 134. Participants also receive oral acetaminophen on Day -2, Day 6, 62, and 83.
  • Placebo Comparator: Part 2: Placebo
    Part 2: Participants receive multiple SC doses of Placebo titrated from Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, or Dosage 6. Participants receive a SC dose of Placebo, Dosage 1 on Days 1 and 8; Dosage 2 on Days 15 and 22; Dosage 3 on Days 29, 36, 43 and 50; Dosage 4 on Days 57, 64, 71 and 78; Dosage 5 on Days 85, 92, 99, 106; and Dosage 6 on Days 113, 120, 127, and 134. Participants also receive oral acetaminophen on Day -2, Day 6, 62, and 83.

Primary Outcome Measure

Part 1: Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 35 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
QPS-MRA, LLC (Site 0001)South MiamiFlorida33143-

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By research site
QPS-MRA, LLC· South Miami, FL

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