Clinical trial NCT06836037: A Clinical Study of Efinopegdutide (MK-6024) in Healthy Chinese Volunteers (MK-6024-011)
Official title: A Single and Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics of MK-6024 in Healthy Chinese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-02-20
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 112 days
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 78 days
measure: Maximum Plasma Concentration (Cmax) of Efinopegdutide- single dose
timeFrame: At designated time points up to 35 days
measure: Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- single dose
timeFrame: At designated time points up to 35 days
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide- single dose
timeFrame: At designated timepoints up to 35 days
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of Efinopegdutide- single dose
timeFrame: At designated timepoints up to 35 days
measure: Terminal half life (t1/2) of Efinopegdutide- single dose
timeFrame: At designated timepoints up to 35 days
measure: Apparent Clearance (CL) of Efinopegdutide- single dose
timeFrame: At designated timepoints up to 35 days
measure: Volume of Distribution (Vz) of Efinopegdutide- single dose
timeFrame: At designated timepoints up to 35 days
measure: Maximum Plasma Concentration (Cmax) of Efinopegdutide- multiple dose
timeFrame: At designated time points up to 112 days
measure: Minimum Plasma Concentration (Cmin) of Efinopegdutide- multiple dose
timeFrame: At designated time points up to 112 days
measure: Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- multiple dose
timeFrame: At designated time points up to 112 days
measure: Terminal half life (t1/2) of Efinopegdutide- multiple dose
timeFrame: At designated timepoints up to 112 days
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide-multiple dose
timeFrame: At designated timepoints up to 112 days
measure: Apparent Clearance (CL) of Efinopegdutide- multiple dose
timeFrame: At designated timepoints up to 112 days
measure: Volume of Distribution at Steady State (Vss) of Efinopegdutide- multiple dose
timeFrame: At designated timepoints up to 112 days
measure: Area Under the Concentration-Time Curve to the end of the dosing period (AUC 0-tau)of Efinopegdutide- multiple dose
timeFrame: At designated timepoints up to 78 days
Secondary outcomes:
measure: Change from Baseline in Weight
timeFrame: Baseline and day 112
measure: Change from Baseline in HDL Cholesterol
timeFrame: Baseline and day 112
measure: Change from Baseline in LDL Cholesterol
timeFrame: Baseline and day 112
measure: Change from Baseline in Total Cholesterol
timeFrame: Baseline and day 112
measure: Change from Baseline in Triglycerides
timeFrame: Baseline and day 112
measure: Number of participants with anti drug antibodies (ADA) to efinopegdutide
timeFrame: At designated timepoints up to 112 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)
state: Shanghai
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: