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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-05

Study Completion Date

2023-02-02

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Efinopegdutide Low Dose

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

Group Type EXPERIMENTAL

Efinopegdutide

Intervention Type DRUG

Subcutaneous injection

Efinopegdutide Medium dose

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

Group Type EXPERIMENTAL

Efinopegdutide

Intervention Type DRUG

Subcutaneous injection

Efinopegdutide High Dose

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

Group Type EXPERIMENTAL

Efinopegdutide

Intervention Type DRUG

Subcutaneous injection

Efinopegdutide Multiple Dose

Participants receive multiple doses of efinopegdutide over 78 days

Group Type EXPERIMENTAL

Efinopegdutide

Intervention Type DRUG

Subcutaneous injection

Placebo

Participants receive placebo to match efinopegdutide dose and regimen

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo matching efinopegdutide

Interventions

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Efinopegdutide

Subcutaneous injection

Intervention Type DRUG

Placebo

placebo matching efinopegdutide

Intervention Type DRUG

Other Intervention Names

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MK-6024 HM12525A JNJ-64565111,

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes