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

August 3, 2026 updated by: Merck Sharp & Dohme LLC

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

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 alone (Part 1, Period 1 and Part 2) and in combination with (Part 1, 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Recruiting
        • Anaheim Clinical Trials ( Site 0001)
        • Contact:
          • Study Coordinator
          • Phone Number: 714-774-7777

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MK-4082
Participants will move sequentially through 2 periods in Part 1. In Period 1, participants will receive a single oral dose of MK-4082 on Day 1. In Period 2, participants will receive a single oral dose of MK-4082 on Day 1 plus oral diltiazem for multiple days. In Part 2 participants receive a single dose of MK-4082 or placebo.
Drug: Diltiazem
Oral administration
Drug: MK-4082
Oral administration
Drug: Rescue medication
All participants will receive ondansetron as a rescue medication. Ondansetron is a medication used to prevent nausea or vomiting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of MK-4082
Time Frame: At designated timepoints (up to approximately 1 week postdose)
Blood samples will be collected to determine the AUC0-∞ of MK-4082.
At designated timepoints (up to approximately 1 week postdose)
Part 1: 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.
At designated timepoints (up to approximately 1 week postdose)
Part 1: 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.
Up to approximately 31 days
Part 1: 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.
Up to approximately 17 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 2: AUC0-∞ of MK-4082
Time Frame: At designated timepoints (up to approximately 1 week postdose)
Blood samples will be collected to determine the AUC0-∞ of MK-4082.
At designated timepoints (up to approximately 1 week postdose)
Part 2: AUC0-24 of MK-4082
Time Frame: At designated timepoints (up to 24 hours postdose)
Blood samples will be collected to determine the AUC0-24 of MK-4082.
At designated timepoints (up to 24 hours postdose)
Part 2: 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.
At designated timepoints (up to approximately 1 week postdose)
Part 2: Time to maximum plasma concentration (Tmax) of MK-4082
Time Frame: At designated timepoints (up to approximately 1 week postdose)
Blood samples will be collected to determine the Tmax of MK-4082.
At designated timepoints (up to approximately 1 week postdose)
Part 2: Plasma concentration 24 hours postdose (C24) of MK-4082
Time Frame: 24 hours postdose
Blood samples will be collected to determine the C24 of MK-4082.
24 hours postdose
Part 2: Apparent terminal half-life (t½) of MK-4082
Time Frame: At designated timepoints (up to approximately 1 week postdose)
Blood samples will be collected to determine the t½ of MK-4082.
At designated timepoints (up to approximately 1 week postdose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2026

Primary Completion (Estimated)

September 28, 2026

Study Completion (Estimated)

September 28, 2026

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4082-005
  • MK-4082-005 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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