A Study of Efinopegdutide in Healthy Obese Participants (MK-6024-015)
February 24, 2025 updated by: Merck Sharp & Dohme LLC
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
South Miami, Florida, United States, 33143
- QPS-MRA, LLC (Site 0001)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Part 1: Efinopegdutide
Part 1: Participants receive a single subcutaneous (SC) dose of efinopegdutide.
|
Subcutaneous injectable solution
Other Names:
|
|
Placebo Comparator: Part 1: Placebo
Part 1: Participants receive a single SC dose of placebo.
|
Subcutaneous injectable solution
|
|
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.
|
Subcutaneous injectable solution
Other Names:
Oral solution
|
|
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. |
Subcutaneous injectable solution
Oral solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to approximately 35 days
|
|
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.
|
Up to approximately 35 days
|
|
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.
|
Pre-dose and at designated time points up to 35 days post dose
|
|
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.
|
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
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.
|
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
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.
|
Pre-dose and at designated time points up to 35 days post dose
|
|
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.
|
Pre-dose and at designated time points up to 35 days post dose
|
|
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.
|
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
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.
|
Pre-dose and at designated time points up to 35 days post dose
|
|
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.
|
Up to approximately 184 days
|
|
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.
|
Up to approximately 184 days
|
|
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.
|
At designated time points up to approximately 184 days
|
|
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.
|
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
Time Frame: At designated time points up to approximately 184 days
|
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
Time Frame: At designated time points up to approximately 184 days
|
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
Time Frame: At designated time points up to approximately 184 days
|
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
Time Frame: At designated time points up to approximately 184 days
|
Blood samples will be collected to determine the Ctrough of Efinopegdutide.
|
At designated time points up to approximately 184 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At designated time points up to approximately 184 days
|
|
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.
|
At designated time points up to approximately 184 days
|
|
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.
|
At designated time points up to approximately 184 days
|
|
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.
|
At designated time points up to approximately 184 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 13, 2024
Primary Completion (Actual)
February 18, 2025
Study Completion (Actual)
February 18, 2025
Study Registration Dates
First Submitted
November 20, 2024
First Submitted That Met QC Criteria
November 20, 2024
First Posted (Actual)
November 22, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 24, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6024-015
- MK-6024-015 (Other Identifier: MSD)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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