Efinopegdutide for Obesity

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Endocrine, Cardiovascular, Cancer, others

Compensation: Varies

Number of Visits: 1

48 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to learn about the safety of efinopegdutide (MK-6024) and how well overweight healthy people tolerate it. Researchers also want to know what happens to efinopegdutide in a person's body over time when taken as a single dose (Part 1) or as multiple doses (Part 2). In addition, the study will assess the amount of acetaminophen in the blood after receiving different strength doses of efinopegdutide (Part 2 only).

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for healthy, overweight individuals interested in testing a new drug called Efinopegdutide. Participants should not have any significant health issues and must be willing to take the medication as directed.

Inclusion Criteria

I am in good health overall.

Has body mass index (BMI) between 29 kg/m^2 and 38 kg/m^2

Exclusion Criteria

Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or Human immunodeficiency virus (HIV)

I have had cancer before.

I have a significant history of major health issues like heart, liver, or kidney diseases.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive a single subcutaneous (SC) dose of efinopegdutide or placebo

1 week

1 visit (in-person)

Treatment Part 2

Participants receive multiple SC doses of efinopegdutide or placebo, titrated over several weeks

19 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Efinopegdutide

Trial Overview The study tests the safety of Efinopegdutide in obese but otherwise healthy people. It involves taking a single dose or multiple doses over time (in two separate parts), and also looks at how it affects acetaminophen levels in the blood.

Participant Groups

Group I: Part 2: Efinopegdutide Experimental Treatment 2 Interventions

Part 2: Participants receive multiple SC doses of efinopegdutide titrated from Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, or Dosage 6. Participants receive a SC dose of efinopegdutide, Dosage 1 on Days 1 and 8; Dosage 2 on Days 15 and 22; Dosage 3 on Days 29, 36, 43 and 50; Dosage 4 on Days 57, 64, 71 and 78; Dosage 5 on Days 85, 92, 99, 106; and Dosage 6 on Days 113, 120, 127, and 134. Participants also receive oral acetaminophen on Day -2, Day 6, 62, and 83.

Group II: Part 1: Efinopegdutide Experimental Treatment 1 Intervention

Part 1: Participants receive a single subcutaneous (SC) dose of efinopegdutide.

Group III: Part 2: Placebo Placebo Group 2 Interventions

Part 2: Participants receive multiple SC doses of Placebo titrated from Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, or Dosage 6. Participants receive a SC dose of Placebo, Dosage 1 on Days 1 and 8; Dosage 2 on Days 15 and 22; Dosage 3 on Days 29, 36, 43 and 50; Dosage 4 on Days 57, 64, 71 and 78; Dosage 5 on Days 85, 92, 99, 106; and Dosage 6 on Days 113, 120, 127, and 134. Participants also receive oral acetaminophen on Day -2, Day 6, 62, and 83.

Group IV: Part 1: Placebo Placebo Group 1 Intervention

Part 1: Participants receive a single SC dose of placebo.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University