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

NCT06836037 | Completed Phase 1 FDA Drug

• 3 other identifiers: 6024-011MK-6024-0112020-005136-30
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (17)

• 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 Outcomes (6)

• Change from Baseline in Weight

  Baseline and day 112

• Change from Baseline in HDL Cholesterol

  Baseline and day 112

• Change from Baseline in LDL Cholesterol

  Baseline and day 112

• Change from Baseline in Total Cholesterol

  Baseline and day 112

• Change from Baseline in Triglycerides

  Baseline and day 112

Study Arms (5)

Efinopegdutide Low Dose

EXPERIMENTAL

Participants receive low dose efinopegdutide at a single dose on day 1

Drug: Efinopegdutide

Efinopegdutide Medium dose

EXPERIMENTAL

Participants receive medium dose efinopegdutide at a single dose on day 1

Drug: Efinopegdutide

Efinopegdutide High Dose

EXPERIMENTAL

Participants receive high dose efinopegdutide at a single dose on day 1

Drug: Efinopegdutide

Efinopegdutide Multiple Dose

EXPERIMENTAL

Participants receive multiple doses of efinopegdutide over 78 days

Drug: Efinopegdutide

Placebo

PLACEBO COMPARATOR

Participants receive placebo to match efinopegdutide dose and regimen

Drug: Placebo

Interventions

Efinopegdutide DRUG

Subcutaneous injection

Also known as: MK-6024, HM12525A, JNJ-64565111,

Efinopegdutide High Dose; Efinopegdutide Low Dose; Efinopegdutide Medium dose; Efinopegdutide Multiple Dose

Placebo DRUG

placebo matching efinopegdutide

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)

Shanghai, Shanghai Municipality, 200032, China

Location

Related Links

• Merck Clinical Trials Information

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: February 18, 2025
• First Posted: February 20, 2025
• Study Start: September 5, 2022
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)