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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Efinopegdutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06836037

6024-011

2020-005136-30 (EudraCT Number)

MK-6024-011 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 5 patient groups, including a placebo group

Efinopegdutide Low Dose

Experimental group

Description:

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

Treatment:

Drug: Efinopegdutide

Efinopegdutide Medium dose

Experimental group

Description:

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

Treatment:

Drug: Efinopegdutide

Efinopegdutide High Dose

Experimental group

Description:

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

Treatment:

Drug: Efinopegdutide

Efinopegdutide Multiple Dose

Experimental group

Description:

Participants receive multiple doses of efinopegdutide over 78 days

Treatment:

Drug: Efinopegdutide

Placebo

Placebo Comparator group

Description:

Participants receive placebo to match efinopegdutide dose and regimen

Treatment:

Drug: Placebo