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Completed

NCT Number: NCT06836037

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

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.

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Key information

Conditions

Healthy

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efinopegdutide

Drug

Subcutaneous injection

Other names: MK-6024, HM12525A, JNJ-64565111,

Placebo

Drug

placebo matching efinopegdutide

Primary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: 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.

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: 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.

  3. Maximum Plasma Concentration (Cmax) of Efinopegdutide- single dose

    Time frame: 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

  4. Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- single dose

    Time frame: 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

  5. Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide- single dose

    Time frame: 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

  6. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of Efinopegdutide- single dose

    Time frame: 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

  7. Terminal half life (t1/2) of Efinopegdutide- single dose

    Time frame: 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

  8. Apparent Clearance (CL) of Efinopegdutide- single dose

    Time frame: At designated timepoints up to 35 days

    Blood samples will be collected to determine the CL of efinopegdutide when administered as a single dose

  9. Volume of Distribution (Vz) of Efinopegdutide- single dose

    Time frame: At designated timepoints up to 35 days

    Blood samples will be collected to determine the Vz of efinopegdutide when administered as a single dose

  10. Maximum Plasma Concentration (Cmax) of Efinopegdutide- multiple dose

    Time frame: At designated time points up to 112 days

    Blood samples will be collected to determine the Cmax of efinopegdutide when multiple doses are administered

  11. Minimum Plasma Concentration (Cmin) of Efinopegdutide- multiple dose

    Time frame: At designated time points up to 112 days

    Blood samples will be collected to determine the Cmin of efinopegdutide when multiple doses are administered

  12. Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- multiple dose

    Time frame: At designated time points up to 112 days

    Blood samples will be collected to determine the Tmax of efinopegdutide when multiple doses are administered

  13. Terminal half life (t1/2) of Efinopegdutide- multiple dose

    Time frame: At designated timepoints up to 112 days

    Blood samples will be collected to determine the t1/2 of efinopegdutide when multiple doses are administered

  14. Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide-multiple dose

    Time frame: At designated timepoints up to 112 days

    Blood samples will be collected to determine the AUC0-last of efinopegdutide when multiple doses are administered

  15. Apparent Clearance (CL) of Efinopegdutide- multiple dose

    Time frame: At designated timepoints up to 112 days

    Blood samples will be collected to determine the CL of efinopegdutide when multiple doses are administered

  16. Volume of Distribution at Steady State (Vss) of Efinopegdutide- multiple dose

    Time frame: At designated timepoints up to 112 days

    Blood samples will be collected to determine the Vss of efinopegdutide when multiple doses are administered

  17. Area Under the Concentration-Time Curve to the end of the dosing period (AUC 0-tau)of Efinopegdutide- multiple dose

    Time frame: 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 outcomes

  1. Change from Baseline in Weight

    Time frame: Baseline and day 112

    Change from baseline in weight will be computed for participants who received multiple doses of efinopegdutide

  2. Change from Baseline in HDL Cholesterol

    Time frame: Baseline and day 112

    Change from baseline in HDL cholesterol will be computed for participants who received multiple doses of efinopegdutide

  3. Change from Baseline in LDL Cholesterol

    Time frame: Baseline and day 112

    Change from baseline in LDL cholesterol will be computed for participants who received multiple doses of efinopegdutide

  4. Change from Baseline in Total Cholesterol

    Time frame: Baseline and day 112

    Change from baseline in total cholesterol will be computed for participants who received multiple doses of efinopegdutide

  5. Change from Baseline in Triglycerides

    Time frame: Baseline and day 112

    Change from baseline in triglycerides will be computed for participants who received multiple doses of efinopegdutide

  6. Number of participants with anti drug antibodies (ADA) to efinopegdutide

    Time frame: At designated timepoints up to 112 days

    Blood samples will be collected to determine the number of participants with ADA to efinopegdutide

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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