Healthy
Conditions
Brief summary
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) of the study medicine that can be used in future studies. The goals of this study are to learn about: * The safety of MK-4082 and if people tolerate it * What happens to different MK-4082 dose levels in a person's body over time
Interventions
DRUGMK-4082
Oral Tablet
DRUGPlacebo
Oral Tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Is in good health * Has body mass index (BMI) between 25 and 40 kg/m\^2, inclusive. Participants must weigh at least 60 kg
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 98 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. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 84 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 discontinue study treatment due to an AE will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-4082 | At designated timepoints (up to 24 hours postdose) | Blood samples will be collected to determine the AUC0-24hr of MK-4082. |
| Time to Maximum Plasma Concentration (Tmax) of MK-4082 | Predose and at designated timepoints up to 84 Days postdose | Blood samples will be collected to determine the Tmax of MK-4082. |
| Maximum Plasma Concentration (Cmax) of MK-4082 | Predose and at designated timepoints up to 84 Days postdose | Blood samples will be collected to determine the Cmax of MK-4082. |
| Plasma Concentration at 24 Hours (C24) of MK-4082 | At designated timepoints up to 24 hours postdose | Blood samples will be collected to determine the C24 of MK-4082. |
| Area Under the Curve from Time 0 to Infinity (AUC0-Inf) of MK-4082 | Predose and at designated timepoints up to 84 Days postdose | Blood samples will be collected to determine the AUC0-Inf of MK-4082. |
| Area Under the Curve from Time 0 to Last (AUC0-Last) of MK-4082 | Predose and at designated timepoints up to 84 Days postdose | Blood samples will be collected to determine the AUC0-last of MK-4082. |
| Apparent Clearance (CL/F) of MK-4082 | Predose and at designated timepoints up to 84 Days postdose | Blood samples will be collected to determine the CL/F of MK-4082. |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-4082 | Predose and at designated timepoints up to 84 Days postdose | Blood samples will be collected to determine the Vz/F of MK-4082. |
| Apparent Terminal Half-life (t1/2) of MK-4082 | Predose and at designated timepoints up to 84 Days postdose | Blood samples will be collected to determine the t1/2of MK-4082. |
| Change from Baseline in Body Weight | Baseline and up to approximately 84 Days | Change from baseline in body weight will be reported. |
| Change from Baseline in Body Mass Index (BMI) | Baseline and up to approximately 84 Days | Change from baseline in body mass index (BMI) will be reported. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed