A Clinical Trial of Multiple Formulations of MK-4082 in Healthy Overweight and Obese Participants (MK-4082-007)

Phase 1Not Yet RecruitingNCT07748351

Merck Sharp & Dohme LLC48 enrolled

Overview

Researchers are looking for new weight loss medicines for people with higher body weight. The study medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a study medicine to people with a health condition, researchers first do studies to find a safe dose level (amount) and formulation (version) of the study medicine that can be used in future studies. The goals of this study are to learn about: The safety of different formulations of MK-4082 and if people tolerate them What happens to different formulations of MK-4082 in a person's body over time

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Is in good health * Has a body mass index (BMI) between 25 and 40 kg/m\^2, inclusive and weighs at least 60 kg Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history of previous surgical treatment for obesity that may induce malabsorption, history of bowel resection \>20 cm, any malabsorption disorder, severe gastroparesis, or any GI procedure for weight loss * Has an individual or family history of medullary thyroid carcinoma or multiple endocrine neoplasia 2

Outcomes

Primary Outcomes

Number of Participants Who Experience an Adverse Event (AE)

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.

Time frame: Up to approximately 8 weeks

Number of Participants Who Discontinue Study Treatment Due to an AE

Time frame: Up to approximately 6 weeks

Secondary Outcomes

Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-4082

Blood samples will be collected to determine the AUC0-24 of MK-4082.

Time frame: At designated timepoints (up to 24 hours postdose)

Plasma Concentration at 24 Hours (C24) of MK-4082

Blood samples will be collected to determine the C24 of MK-4082.

Time frame: At designated timepoints up to 24 hours postdose