A Single and Multiple-Ascending Dose Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Efinopegdutide (MK-6024) in Otherwise Healthy Obese Participants and the Effect of Multiple Doses of Efinopegdutide on the Pharmacokinetics of Acetaminophen

Merck Sharp & Dohme LLC1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2024年6月13日最近更新: 2025年2月26日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 48
试验地点: 1
主要终点: Part 1: Number of Participants Who Experience an Adverse Event (AE)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•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

排除标准

•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)

研究组 & 干预措施

Part 1: Efinopegdutide

Experimental

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

干预措施: Efinopegdutide (Drug)

Part 1: Placebo

Placebo Comparator

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

干预措施: Placebo (Drug)

Part 2: Efinopegdutide

Experimental

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.

干预措施: Efinopegdutide (Drug)

Part 2: Efinopegdutide

Experimental

干预措施: Acetaminophen (Drug)

Part 2: Placebo

Placebo Comparator

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.

干预措施: Placebo (Drug)

Part 2: Placebo

Placebo Comparator

Part 2: Participants receive multiple SC doses of Placebo titrated from Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, or Dosage 6.

干预措施: Acetaminophen (Drug)

结局指标

主要结局

Part 1: Number of Participants Who Experience an Adverse Event (AE)

时间窗: Up to approximately 35 days

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE

时间窗: Up to approximately 35 days

Part 1: Maximum Plasma Concentration (Cmax) of Efinopegdutide