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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Efinopegdutide; Drug: Placebo

• Registration Number: NCT06836037
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-05
• Primary Completion: 2023-02-02
• Study Completion: 2023-02-02
• Status Verified: 2025-02
• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Efinopegdutide Low Dose	Efinopegdutide	Participants receive low dose efinopegdutide at a single dose on day 1
Efinopegdutide Medium dose	Efinopegdutide	Participants receive medium dose efinopegdutide at a single dose on day 1
Efinopegdutide High Dose	Efinopegdutide	Participants receive high dose efinopegdutide at a single dose on day 1
Efinopegdutide Multiple Dose	Efinopegdutide	Participants receive multiple doses of efinopegdutide over 78 days
Placebo	Placebo	Participants receive placebo to match efinopegdutide dose and regimen

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 112 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.
Number of Participants Who Discontinue Study Treatment Due to an AE	Up to approximately 78 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.
Maximum Plasma Concentration (Cmax) of Efinopegdutide- single dose	At designated time points up to 35 days	Blood samples will be collected to determine the Cmax of efinopegdutide when administered as a single dose
Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- single dose	At designated time points up to 35 days	Blood samples will be collected to determine the Tmax of efinopegdutide when administered as a single dose
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide- single dose	At designated timepoints up to 35 days	Blood samples will be collected to determine the AUC0-last of efinopegdutide when administered as a single dose
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of Efinopegdutide- single dose	At designated timepoints up to 35 days	Blood samples will be collected to determine the AUC0-inf of efinopegdutide when administered as a single dose
Terminal half life (t1/2) of Efinopegdutide- single dose	At designated timepoints up to 35 days	Blood samples will be collected to determine the t1/2 of efinopegdutide when administered as a single dose
Apparent Clearance (CL) of Efinopegdutide- single dose	At designated timepoints up to 35 days	Blood samples will be collected to determine the CL of efinopegdutide when administered as a single dose
Volume of Distribution (Vz) of Efinopegdutide- single dose	At designated timepoints up to 35 days	Blood samples will be collected to determine the Vz of efinopegdutide when administered as a single dose
Maximum Plasma Concentration (Cmax) of Efinopegdutide- multiple dose	At designated time points up to 112 days	Blood samples will be collected to determine the Cmax of efinopegdutide when multiple doses are administered
Minimum Plasma Concentration (Cmin) of Efinopegdutide- multiple dose	At designated time points up to 112 days	Blood samples will be collected to determine the Cmin of efinopegdutide when multiple doses are administered
Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- multiple dose	At designated time points up to 112 days	Blood samples will be collected to determine the Tmax of efinopegdutide when multiple doses are administered
Terminal half life (t1/2) of Efinopegdutide- multiple dose	At designated timepoints up to 112 days	Blood samples will be collected to determine the t1/2 of efinopegdutide when multiple doses are administered
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide-multiple dose	At designated timepoints up to 112 days	Blood samples will be collected to determine the AUC0-last of efinopegdutide when multiple doses are administered
Apparent Clearance (CL) of Efinopegdutide- multiple dose	At designated timepoints up to 112 days	Blood samples will be collected to determine the CL of efinopegdutide when multiple doses are administered
Volume of Distribution at Steady State (Vss) of Efinopegdutide- multiple dose	At designated timepoints up to 112 days	Blood samples will be collected to determine the Vss of efinopegdutide when multiple doses are administered
Area Under the Concentration-Time Curve to the end of the dosing period (AUC 0-tau)of Efinopegdutide- multiple dose	At designated timepoints up to 78 days	Blood samples will be collected to determine the AUC0 to tau of efinopegdutide when multiple doses are administered

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001); 🇨🇳 Shanghai, Shanghai, China