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CompletedNCT06701305Updated Feb 26, 2025

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

A Phase 1 interventional study of Efinopegdutide and Placebo in Healthy, sponsored by Merck Sharp & Dohme LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-26.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Feb 2025, 1 year 7 months ago, and no results have been posted to the registry.
  • Registered 5 months after the study started (first participant enrolled Jun 2024, registered Nov 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • Is in good health
  • Has body mass index (BMI) between 29 kg/m\^2 and 38 kg/m\^2

Exclusion criteria

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • History of cancer (malignancy)
  • Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or Human immunodeficiency virus (HIV)
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Part 1: Efinopegdutide

    Part 1: Participants receive a single subcutaneous (SC) dose of efinopegdutide.

    Drug: Efinopegdutide

  • Placebo comparator
    Part 1: Placebo

    Part 1: Participants receive a single SC dose of placebo.

    Drug: 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.

    Drug: Efinopegdutide · Drug: Acetaminophen

  • 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.

    Drug: Placebo · Drug: Acetaminophen

Interventions

  • DrugEfinopegdutide

    Subcutaneous injectable solution

    Also known as: MK-6024

  • DrugPlacebo

    Subcutaneous injectable solution

  • DrugAcetaminophen

    Oral solution

06

What researchers measure

Primary outcomes

  1. Part 1: Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

    Time frame: Up to approximately 35 days

  2. Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

    Time frame: Up to approximately 35 days

  3. Part 1: Maximum Plasma Concentration (Cmax) of Efinopegdutide

    Blood samples will be collected to determine the Cmax of Efinopegdutide.

    Time frame: Pre-dose and at designated time points up to 35 days post dose

  4. Part 1: Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide

    Blood samples will be collected to determine the Tmax of Efinopegdutide.

    Time frame: Pre-dose and at designated time points up to 35 days post dose

  5. Part 1: Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-last) of Efinopegdutide

    Blood samples will be collected to determine the AUC0-last of Efinopegdutide.

    Time frame: Pre-dose and at designated time points up to 35 days post dose

  6. Part 1: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Efinopegdutide

    Blood samples will be collected to determine the AUC0-Inf of Efinopegdutide.

    Time frame: Pre-dose and at designated time points up to 35 days post dose

  7. Part 1: Apparent Terminal Half-life (t1/2) of Efinopegdutide

    Blood samples will be collected to determine the t1/2 of Efinopegdutide.

    Time frame: Pre-dose and at designated time points up to 35 days post dose

  8. Part 1: Apparent Clearance (CL/F) of Efinopegdutide

    Blood samples will be collected to determine the CL/F of Efinopegdutide.

    Time frame: Pre-dose and at designated time points up to 35 days post dose

  9. Part 1: Apparent volume of distribution during terminal phase (Vz/F) of Efinopegdutide

    Blood samples will be collected to determine the Vz/F of Efinopegdutide.

    Time frame: Pre-dose and at designated time points up to 35 days post dose

  10. Part 2: Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

    Time frame: Up to approximately 184 days

  11. Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

    Time frame: Up to approximately 184 days

  12. Part 2: Cmax of Efinopegdutide

    Blood samples will be collected to determine the Cmax of Efinopegdutide.

    Time frame: At designated time points up to approximately 184 days

  13. Part 2: Tmax of Efinopegdutide

    Blood samples will be collected to determine the Tmax of Efinopegdutide.

    Time frame: At designated time points up to approximately 184 days

  14. Part 2: Area Under the Concentration-Time Curve from Time 0 to the End of the Dosing Interval (AUC0-tau) of Efinopegdutide

    Blood samples will be collected to determine the AUC0-tau of Efinopegdutide.

    Time frame: At designated time points up to approximately 184 days

  15. Part 2: t1/2 of Efinopegdutide

    Blood samples will be collected to determine the CL/F of Efinopegdutide.

    Time frame: At designated time points up to approximately 184 days

  16. Part 2: Vz/F of Efinopegdutide

    Blood samples will be collected to determine the Vz/F of Efinopegdutide.

    Time frame: At designated time points up to approximately 184 days

  17. Part 2: Concentration Immediately Before the Next Dose is Administered (Ctrough) of Efinopegdutide

    Blood samples will be collected to determine the Ctrough of Efinopegdutide.

    Time frame: At designated time points up to approximately 184 days

Secondary outcomes

  1. Part 2: AUC0-Inf of Acetaminophen

    Blood samples will be collected to determine the AUC0-inf of Acetaminophen.

    Time frame: At designated time points up to approximately 184 days

  2. Part 2: Cmax of Acetaminophen

    Blood samples will be collected to determine the Cmax of Acetaminophen.

    Time frame: At designated time points up to approximately 184 days

  3. Part 2: Tmax of Acetaminophen

    Blood samples will be collected to determine the Tmax of Acetaminophen.

    Time frame: At designated time points up to approximately 184 days

  4. Part 2: t1/2 of Acetaminophen

    Blood samples will be collected to determine the t1/2 of Acetaminophen.

    Time frame: At designated time points up to approximately 184 days

07

Study locations

1 site
  • QPS-MRA, LLC (Site 0001)
    South Miami, Florida 33143, United States
08

References and documents

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06701305
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Nov 22, 2024
Start date
Jun 13, 2024
Primary completion
Feb 18, 2025
Completion
Feb 18, 2025
Last update
Feb 26, 2025

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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