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

NCT07388667 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 4082-002MK-4082-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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) 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

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 98 Days

• 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 84 Days

Secondary Outcomes (11)

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

  At designated timepoints (up to 24 hours postdose)

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

  Predose and at designated timepoints up to 84 Days postdose

• Maximum Plasma Concentration (Cmax) of MK-4082

  Predose and at designated timepoints up to 84 Days postdose

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

  At designated timepoints up to 24 hours postdose

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

  Predose and at designated timepoints up to 84 Days postdose

Study Arms (5)

Panel A: Dose Escalation to Dosage 1

EXPERIMENTAL

Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 1.

Drug: MK-4082; Drug: Placebo

Panel B: Dose Escalation to Dosage 2

EXPERIMENTAL

Participants receive escalating doses of oral MK-4082 QD or a dose-matched placebo to reach maintenance dose 2.

Drug: MK-4082; Drug: Placebo

Panel C: Dose Escalation to Dosage 3

EXPERIMENTAL

Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 3.

Drug: MK-4082; Drug: Placebo

Panel D: Dose Escalation to Dosage 4

EXPERIMENTAL

Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 4.

Drug: MK-4082; Drug: Placebo

Panel E: Dose Escalation to Dosage 5

EXPERIMENTAL

Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 5.

Drug: MK-4082; Drug: Placebo

Interventions

MK-4082 DRUG

Oral Tablet

Panel A: Dose Escalation to Dosage 1; Panel B: Dose Escalation to Dosage 2; Panel C: Dose Escalation to Dosage 3; Panel D: Dose Escalation to Dosage 4; Panel E: Dose Escalation to Dosage 5

Placebo DRUG

Oral Tablet

Panel A: Dose Escalation to Dosage 1; Panel B: Dose Escalation to Dosage 2; Panel C: Dose Escalation to Dosage 3; Panel D: Dose Escalation to Dosage 4; Panel E: Dose Escalation to Dosage 5

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 body mass index (BMI) between 25 and 40 kg/m\^2, inclusive. Participants must weigh at least 60 kg

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (5)

Anaheim Clinical Trials ( Site 0005)

Anaheim, California, 92801, United States

RECRUITING

ProSciento Inc. ( Site 0002)

Chula Vista, California, 91911, United States

RECRUITING

QPS-MRA, LLC ( Site 0003)

South Miami, Florida, 33143, United States

RECRUITING

Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0004)

Springfield, Missouri, 65802, United States

RECRUITING

Hassman Research Institute Marlton Site ( Site 0006)

Marlton, New Jersey, 08053, United States

RECRUITING

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): August 19, 2026
• Study Completion (Estimated): August 19, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (5)