A Clinical Study of Efinopegdutide (MK-6024) in Healthy Chinese Volunteers (MK-6024-011)

A Single and Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics of MK-6024 in Healthy Chinese Participants

The goal of this study is to learn about the safety and whether people tolerate a study medicine called efinopegdutide. The study will also measure what happens to efinopegdutide in a healthy person's body over time.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Efinopegdutide

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

• Is in good health before randomization
• Has a body mass index (BMI) ≥25 and ≤35 kg/m^2

Exclusion Criteria:

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

• Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Had major surgery, donated or lost approximately 400 mL blood within 4 weeks prior to entering the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Efinopegdutide Low Dose; Participants receive low dose efinopegdutide at a single dose on day 1	Drug: Efinopegdutide; Subcutaneous injection; Other Names: MK-6024; HM12525A; JNJ-64565111,
Experimental: Efinopegdutide Medium dose; Participants receive medium dose efinopegdutide at a single dose on day 1	Drug: Efinopegdutide; Subcutaneous injection; Other Names: MK-6024; HM12525A; JNJ-64565111,
Experimental: Efinopegdutide High Dose; Participants receive high dose efinopegdutide at a single dose on day 1	Drug: Efinopegdutide; Subcutaneous injection; Other Names: MK-6024; HM12525A; JNJ-64565111,
Experimental: Efinopegdutide Multiple Dose; Participants receive multiple doses of efinopegdutide over 78 days	Drug: Efinopegdutide; Subcutaneous injection; Other Names: MK-6024; HM12525A; JNJ-64565111,
Placebo Comparator: Placebo; Participants receive placebo to match efinopegdutide dose and regimen	Drug: Placebo; placebo matching efinopegdutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 112 days
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 78 days
Maximum Plasma Concentration (Cmax) of Efinopegdutide- single dose	Blood samples will be collected to determine the Cmax of efinopegdutide when administered as a single dose	At designated time points up to 35 days
Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- single dose	Blood samples will be collected to determine the Tmax of efinopegdutide when administered as a single dose	At designated time points up to 35 days
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide- single dose	Blood samples will be collected to determine the AUC0-last of efinopegdutide when administered as a single dose	At designated timepoints up to 35 days
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of Efinopegdutide- single dose	Blood samples will be collected to determine the AUC0-inf of efinopegdutide when administered as a single dose	At designated timepoints up to 35 days
Terminal half life (t1/2) of Efinopegdutide- single dose	Blood samples will be collected to determine the t1/2 of efinopegdutide when administered as a single dose	At designated timepoints up to 35 days
Apparent Clearance (CL) of Efinopegdutide- single dose	Blood samples will be collected to determine the CL of efinopegdutide when administered as a single dose	At designated timepoints up to 35 days
Volume of Distribution (Vz) of Efinopegdutide- single dose	Blood samples will be collected to determine the Vz of efinopegdutide when administered as a single dose	At designated timepoints up to 35 days
Maximum Plasma Concentration (Cmax) of Efinopegdutide- multiple dose	Blood samples will be collected to determine the Cmax of efinopegdutide when multiple doses are administered	At designated time points up to 112 days
Minimum Plasma Concentration (Cmin) of Efinopegdutide- multiple dose	Blood samples will be collected to determine the Cmin of efinopegdutide when multiple doses are administered	At designated time points up to 112 days
Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- multiple dose	Blood samples will be collected to determine the Tmax of efinopegdutide when multiple doses are administered	At designated time points up to 112 days
Terminal half life (t1/2) of Efinopegdutide- multiple dose	Blood samples will be collected to determine the t1/2 of efinopegdutide when multiple doses are administered	At designated timepoints up to 112 days
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide-multiple dose	Blood samples will be collected to determine the AUC0-last of efinopegdutide when multiple doses are administered	At designated timepoints up to 112 days
Apparent Clearance (CL) of Efinopegdutide- multiple dose	Blood samples will be collected to determine the CL of efinopegdutide when multiple doses are administered	At designated timepoints up to 112 days
Volume of Distribution at Steady State (Vss) of Efinopegdutide- multiple dose	Blood samples will be collected to determine the Vss of efinopegdutide when multiple doses are administered	At designated timepoints up to 112 days
Area Under the Concentration-Time Curve to the end of the dosing period (AUC 0-tau)of Efinopegdutide- multiple dose	Blood samples will be collected to determine the AUC0 to tau of efinopegdutide when multiple doses are administered	At designated timepoints up to 78 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Weight	Change from baseline in weight will be computed for participants who received multiple doses of efinopegdutide	Baseline and day 112
Change from Baseline in HDL Cholesterol	Change from baseline in HDL cholesterol will be computed for participants who received multiple doses of efinopegdutide	Baseline and day 112
Change from Baseline in LDL Cholesterol	Change from baseline in LDL cholesterol will be computed for participants who received multiple doses of efinopegdutide	Baseline and day 112
Change from Baseline in Total Cholesterol	Change from baseline in total cholesterol will be computed for participants who received multiple doses of efinopegdutide	Baseline and day 112
Change from Baseline in Triglycerides	Change from baseline in triglycerides will be computed for participants who received multiple doses of efinopegdutide	Baseline and day 112
Number of participants with anti drug antibodies (ADA) to efinopegdutide	Blood samples will be collected to determine the number of participants with ADA to efinopegdutide	At designated timepoints up to 112 days

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Actual): February 2, 2023
• Study Completion (Actual): February 2, 2023

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 6024-011; 2020-005136-30 (Registry Identifier: EU CT); MK-6024-011 (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
• product manufactured in and exported from the U.S.: Yes