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NCT Number: NCT07388667

A Clinical Study of MK-4082 in Healthy Overweight Participants (MK-4082-002)

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials ( Site 0005), Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria include but are not limited to the following:

  • has a history of previous surgical treatment for obesity (bariatric surgery, gastric banding, etc.) or any other gastrointestinal (GI) surgery that may induce malabsorption, history of bowel resection >20 cm, any malabsorption disorder, severe gastroparesis, or any GI procedure for weight loss (including LAP-BAND®), as well as clinically significant GI disorders (eg, peptic ulcers, severe gastroesophageal reflux disease)
  • has an individual or family history of medullary thyroid carcinoma or multiple endocrine neoplasia 2

Treatment and study plan

MK-4082

Drug

Oral Tablet

Placebo

Drug

Oral Tablet

Primary outcomes

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

    Time frame: 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.

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: 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 outcomes

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

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

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

  2. Time to Maximum Plasma Concentration (Tmax) of MK-4082

    Time frame: Predose and at designated timepoints up to 84 Days postdose

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

  3. Maximum Plasma Concentration (Cmax) of MK-4082

    Time frame: Predose and at designated timepoints up to 84 Days postdose

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

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

    Time frame: At designated timepoints up to 24 hours postdose

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

  5. Area Under the Curve from Time 0 to Infinity (AUC0-Inf) of MK-4082

    Time frame: Predose and at designated timepoints up to 84 Days postdose

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

  6. Area Under the Curve from Time 0 to Last (AUC0-Last) of MK-4082

    Time frame: Predose and at designated timepoints up to 84 Days postdose

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

  7. Apparent Clearance (CL/F) of MK-4082

    Time frame: Predose and at designated timepoints up to 84 Days postdose

    Blood samples will be collected to determine the CL/F of MK-4082.

  8. Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-4082

    Time frame: Predose and at designated timepoints up to 84 Days postdose

    Blood samples will be collected to determine the Vz/F of MK-4082.

  9. Apparent Terminal Half-life (t1/2) of MK-4082

    Time frame: Predose and at designated timepoints up to 84 Days postdose

    Blood samples will be collected to determine the t1/2of MK-4082.

  10. Change from Baseline in Body Weight

    Time frame: Baseline and up to approximately 84 Days

    Change from baseline in body weight will be reported.

  11. Change from Baseline in Body Mass Index (BMI)

    Time frame: Baseline and up to approximately 84 Days

    Change from baseline in body mass index (BMI) will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-4082 in Healthy Overweight/Obese Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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