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

NCT06701305 | Completed Phase 1 FDA Drug

• 2 other identifiers: 6024-015MK-6024-015
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (17)

• 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.

  Up to approximately 35 days

• 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.

  Up to approximately 35 days

• Part 1: Maximum Plasma Concentration (Cmax) of Efinopegdutide

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

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

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

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

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

• 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.

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

• 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.

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

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

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

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

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

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

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

• 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.

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

• 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.

  Up to approximately 184 days

• 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.

  Up to approximately 184 days

• Part 2: Cmax of Efinopegdutide

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

  At designated time points up to approximately 184 days

• Part 2: Tmax of Efinopegdutide

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

  At designated time points up to approximately 184 days

• 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.

  At designated time points up to approximately 184 days

• Part 2: t1/2 of Efinopegdutide

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

  At designated time points up to approximately 184 days

• Part 2: Vz/F of Efinopegdutide

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

  At designated time points up to approximately 184 days

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

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

  At designated time points up to approximately 184 days

Secondary Outcomes (4)

• Part 2: AUC0-Inf of Acetaminophen

  At designated time points up to approximately 184 days

• Part 2: Cmax of Acetaminophen

  At designated time points up to approximately 184 days

• Part 2: Tmax of Acetaminophen

  At designated time points up to approximately 184 days

• Part 2: t1/2 of Acetaminophen

  At designated time points up to approximately 184 days

Study Arms (4)

Part 1: Efinopegdutide

EXPERIMENTAL

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

Drug: Efinopegdutide

Part 1: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part 2: Efinopegdutide

EXPERIMENTAL

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

Part 2: Placebo

PLACEBO COMPARATOR

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

Efinopegdutide DRUG

Subcutaneous injectable solution

Also known as: MK-6024

Part 1: Efinopegdutide; Part 2: Efinopegdutide

Placebo DRUG

Subcutaneous injectable solution

Part 1: Placebo; Part 2: Placebo

Acetaminophen DRUG

Oral solution

Part 2: Efinopegdutide; Part 2: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

QPS-MRA, LLC (Site 0001)

South Miami, Florida, 33143, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: June 13, 2024
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)