Clinical trial NCT06701305: A Study of Efinopegdutide in Healthy Obese Participants (MK-6024-015)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Part 1: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 35 days
measure: Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 35 days
measure: Part 1: Maximum Plasma Concentration (Cmax) of Efinopegdutide
timeFrame: Pre-dose and at designated time points up to 35 days post dose
measure: Part 1: Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide
timeFrame: Pre-dose and at designated time points up to 35 days post dose
measure: Part 1: Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-last) of Efinopegdutide
timeFrame: Pre-dose and at designated time points up to 35 days post dose
measure: Part 1: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Efinopegdutide
timeFrame: Pre-dose and at designated time points up to 35 days post dose
measure: Part 1: Apparent Terminal Half-life (t1/2) of Efinopegdutide
timeFrame: Pre-dose and at designated time points up to 35 days post dose
measure: Part 1: Apparent Clearance (CL/F) of Efinopegdutide
timeFrame: Pre-dose and at designated time points up to 35 days post dose
measure: Part 1: Apparent volume of distribution during terminal phase (Vz/F) of Efinopegdutide
timeFrame: Pre-dose and at designated time points up to 35 days post dose
measure: Part 2: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 184 days
measure: Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 184 days
measure: Part 2: Cmax of Efinopegdutide
timeFrame: At designated time points up to approximately 184 days
measure: Part 2: Tmax of Efinopegdutide
timeFrame: At designated time points up to approximately 184 days
measure: Part 2: Area Under the Concentration-Time Curve from Time 0 to the End of the Dosing Interval (AUC0-tau) of Efinopegdutide
timeFrame: At designated time points up to approximately 184 days
measure: Part 2: t1/2 of Efinopegdutide
timeFrame: At designated time points up to approximately 184 days
measure: Part 2: Vz/F of Efinopegdutide
timeFrame: At designated time points up to approximately 184 days
measure: Part 2: Concentration Immediately Before the Next Dose is Administered (Ctrough) of Efinopegdutide
timeFrame: At designated time points up to approximately 184 days
Secondary outcomes:
measure: Part 2: AUC0-Inf of Acetaminophen
timeFrame: At designated time points up to approximately 184 days
measure: Part 2: Cmax of Acetaminophen
timeFrame: At designated time points up to approximately 184 days
measure: Part 2: Tmax of Acetaminophen
timeFrame: At designated time points up to approximately 184 days
measure: Part 2: t1/2 of Acetaminophen
timeFrame: At designated time points up to approximately 184 days
Other outcomes:
Locations:
city: South Miami
country: United States
facility: QPS-MRA, LLC (Site 0001)
state: Florida
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: