A Study of Efinopegdutide in Healthy Obese Participants (MK-6024-015)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Acetaminophen; Drug: Efinopegdutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06701305

MK-6024-015 (Other Identifier)

6024-015

Details and patient eligibility

About

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).

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

• Is in good health
• Has body mass index (BMI) between 29 kg/m^2 and 38 kg/m^2

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

• History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• History of cancer (malignancy)
• Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or Human immunodeficiency virus (HIV)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 4 patient groups, including a placebo group

Part 1: Efinopegdutide

Experimental group

Description:

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

Treatment:

Drug: Efinopegdutide

Part 1: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Part 2: Efinopegdutide

Experimental group

Description:

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.

Treatment:

Drug: Efinopegdutide

Drug: Acetaminophen

Part 2: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Acetaminophen