A Clinical Trial of Multiple Formulations of MK-4082 in Healthy Overweight and Obese Participants (MK-4082-007)

NCT07748351 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 4082-007MK-4082-007
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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) and formulation (version) of the study medicine that can be used in future studies. The goals of this study are to learn about: The safety of different formulations of MK-4082 and if people tolerate them What happens to different formulations of MK-4082 in a person's body over time

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  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 8 weeks

• Number of Participants Who Discontinue Study Treatment Due to an AE

  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.

  Up to approximately 6 weeks

Secondary Outcomes (2)

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

  At designated timepoints (up to 24 hours postdose)

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

  At designated timepoints up to 24 hours postdose

Study Arms (4)

Panel A Sequence 1

EXPERIMENTAL

Participants will be administered daily oral doses of MK-4082 formulation 1 (F1) and MK-4082 formulation 2 (F2) in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F2 for 7 days followed by daily oral doses of MK-4082 F1 for 7 days.

Drug: MK-4082 Formulation 1 (F1); Drug: MK-4082 Formulation 2 (F2)

Panel A Sequence 2

EXPERIMENTAL

Participants will be administered daily oral doses of MK-4082 F1 and MK-4082 F2 in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F1 for 7 days followed by daily oral doses of MK-4082 F2 for 7 days.

Drug: MK-4082 Formulation 1 (F1); Drug: MK-4082 Formulation 2 (F2)

Panel B Sequence 1

EXPERIMENTAL

Participants will be administered daily oral doses of MK-4082 F1 and MK-4082 formulation 4 (F4) in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F4 for 7 days followed by daily oral doses of MK-4082 F1 for 7 days.

Drug: MK-4082 Formulation 1 (F1); Drug: MK-4082 Formulation 4 (F4)

Panel B Sequence 2

EXPERIMENTAL

Participants will be administered daily oral doses of MK-4082 F1 and MK-4082 F4 in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F1 for 7 days followed by daily oral doses of MK-4082 F4 for 7 days.

Drug: MK-4082 Formulation 1 (F1); Drug: MK-4082 Formulation 4 (F4)

Interventions

MK-4082 Formulation 1 (F1) DRUG

Oral Tablet

Panel A Sequence 1; Panel A Sequence 2; Panel B Sequence 1; Panel B Sequence 2

MK-4082 Formulation 2 (F2) DRUG

Oral Tablet

Panel A Sequence 1; Panel A Sequence 2

MK-4082 Formulation 4 (F4) DRUG

Oral Tablet

Panel B Sequence 1; Panel B Sequence 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is in good health
• Has a body mass index (BMI) between 25 and 40 kg/m\^2, inclusive and weighs at least 60 kg

You may not qualify if:

• 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
• Has an individual or family history of medullary thyroid carcinoma or multiple endocrine neoplasia 2

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (2)

ProSciento Inc. ( Site 0002)

Chula Vista, California, 91911, United States

Location

ICON Early Phase Services ( Site 0003)

San Antonio, Texas, 78232, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

F 4

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: August 25, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (2)