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NCT Number: NCT07697625

A Clinical Trial of MK-4082 in Healthy Participants (MK-4082-005)

Researchers are looking for new weight loss medicines for people with higher body weight. The trial medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a trial medicine to participants with a health condition, researchers first do trials in healthy participants to find a safe dose level (amount) of the trial medicine.

The goal of this study is to learn what happens to MK-4082 in a person's body over time. Researchers will compare what happens to levels of MK-4082 in people's blood when it is taken without (Period 1) and with (Period 2) another medicine called diltiazem. Researchers also want to learn about the safety of MK-4082 taken with and without diltiazem and if people tolerate them.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

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
  • Body mass index (BMI) between 18 and 32 kg/m^2, inclusive

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
  • Had a recent pancreatitis or has a history of pancreatitis

Treatment and study plan

MK-4082

Drug

Oral administration

Diltiazem

Drug

Oral administration

Rescue medication

Drug

All participants will receive ondansetron as a rescue medication. Ondansetron is a medication used to prevent nausea or vomiting.

Primary outcomes

  1. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-4082

    Time frame: At designated timepoints (up to approximately 1 week postdose)

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

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

    Time frame: At designated timepoints (up to approximately 1 week postdose)

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

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

    Time frame: Up to approximately 31 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.

  4. Number of Participants Who Discontinue Study Intervention Due to an AE

    Time frame: Up to approximately 17 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 intervention due to an AE will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Clinical Study to Evaluate the Plasma Pharmacokinetics of a Single Dose of MK-4082 With and Without Diltiazem Coadministration in Healthy Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2026
Registry last updated
Jul 13, 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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