A Clinical Study of Efinopegdutide (MK-6024) in Healthy Chinese Volunteers (MK-6024-011)
- Sponsor
- Merck Sharp & Dohme LLC
- Study ID
- NCT06836037
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - 60 Years
- Healthy Volunteers
- Accepted
Interventions
- Efinopegdutide — DRUGSubcutaneous injection
- Placebo — DRUGplacebo matching efinopegdutide
Study Details
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.
Key Dates
- Start date
- Sep 5, 2022
- Status verified
- Feb 2025
- Primary completion
- Feb 2, 2023
- Completion
- Feb 2, 2023
Study Design
- Enrollment
- 56 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Efinopegdutide Low DoseParticipants receive low dose efinopegdutide at a single dose on day 1
- Experimental: Efinopegdutide Medium doseParticipants receive medium dose efinopegdutide at a single dose on day 1
- Experimental: Efinopegdutide High DoseParticipants receive high dose efinopegdutide at a single dose on day 1
- Experimental: Efinopegdutide Multiple DoseParticipants receive multiple doses of efinopegdutide over 78 days
- Placebo Comparator: PlaceboParticipants receive placebo to match efinopegdutide dose and regimen
Primary Outcome Measure
Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 112 days ]
Related Studies
- Study of New Magnetic Resonance Imaging Methods of the BrainRecruiting · National Institute of Neurological Disorders and Stroke (NINDS) · Bethesda, Maryland
- Mapping Auricular Vagus Nerve CircuitryEARLY_PHASE1 · Recruiting · Massachusetts General Hospital · Boston, Massachusetts
- Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group TestingRecruiting · Cedars-Sinai Medical Center · Los Angeles, California
- Evaluation and Optimization of Ultrasound and/or MRI Hardware and SoftwareRecruiting · State University of New York - Upstate Medical University · Syracuse, New York