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Completed

NCT Number: NCT06701305

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

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).

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

QPS-MRA, LLC (Site 0001)

South Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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)

Treatment and study plan

Efinopegdutide

Drug

Subcutaneous injectable solution

Other names: MK-6024

Placebo

Drug

Subcutaneous injectable solution

Acetaminophen

Drug

Oral solution

Primary outcomes

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

    Time frame: Up to approximately 35 days

    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.

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

    Time frame: Up to approximately 35 days

    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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Time frame: Up to approximately 184 days

    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.

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

    Time frame: Up to approximately 184 days

    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.

  12. Part 2: Cmax of Efinopegdutide

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

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

  13. Part 2: Tmax of Efinopegdutide

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

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

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

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

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

  15. Part 2: t1/2 of Efinopegdutide

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

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

  16. Part 2: Vz/F of Efinopegdutide

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

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

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

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

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

Secondary outcomes

  1. Part 2: AUC0-Inf of Acetaminophen

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

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

  2. Part 2: Cmax of Acetaminophen

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

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

  3. Part 2: Tmax of Acetaminophen

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

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

  4. Part 2: t1/2 of Acetaminophen

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

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Single and Multiple-Ascending Dose Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Efinopegdutide (MK-6024) in Otherwise Healthy Obese Participants and the Effect of Multiple Doses of Efinopegdutide on the Pharmacokinetics of Acetaminophen

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2024
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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