Recruiting
Phase 1

MK-4082 with Diltiazem

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07697625

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

MK-4082

Diltiazem

Rescue medication

Study Details

Brief summary:

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.

Conditions

Healthy

Study ID

NCT07697625

Start date

Jul 20, 2026

Status verified date

Aug, 2026

Completion date

Sep 28, 2026

Anticipated

Primary completion date

Sep 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

28 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

Interventions

MK-4082

Oral administration

Diltiazem

Oral administration

Rescue medication

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

Primary outcome measure

  • 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) ]
  • Part 1: Maximum Plasma Concentration (Cmax) of MK-4082 [ Time Frame: 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 ]
  • Part 1: Number of Participants Who Discontinue Study Intervention Due to an AE [ Time Frame: Up to approximately 17 days ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Anaheim Clinical Trials ( Site 0001)

Recruiting

Anaheim, California, United States, 92801

Contacts

Study Coordinator

714-774-7777

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-05.