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

A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-4082 in Healthy Overweight/Obese Participants

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

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: MK-4082

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials ( Site 0005)
    • Chula Vista, California, United States, 91911
      • ProSciento Inc. ( Site 0002)
  • Florida
    • South Miami, Florida, United States, 33143
      • QPS-MRA, LLC ( Site 0003)
  • Missouri
    • Springfield, Missouri, United States, 65802
      • Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0004)
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Hassman Research Institute Marlton Site ( Site 0006)

Participation Criteria

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

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panel A: Dose Escalation to Dosage 1; Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 1.	Drug: Placebo; Oral Tablet; Drug: MK-4082; Oral Tablet
Experimental: Panel B: Dose Escalation to Dosage 2; Participants receive escalating doses of oral MK-4082 QD or a dose-matched placebo to reach maintenance dose 2.	Drug: Placebo; Oral Tablet; Drug: MK-4082; Oral Tablet
Experimental: Panel C: Dose Escalation to Dosage 3; Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 3.	Drug: Placebo; Oral Tablet; Drug: MK-4082; Oral Tablet
Experimental: Panel D: Dose Escalation to Dosage 4; Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 4.	Drug: Placebo; Oral Tablet; Drug: MK-4082; Oral Tablet
Experimental: Panel E: Dose Escalation to Dosage 5; Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 5.	Drug: Placebo; Oral Tablet; Drug: MK-4082; Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-4082	Blood samples will be collected to determine the AUC0-24hr of MK-4082.	At designated timepoints (up to 24 hours postdose)
Time to Maximum Plasma Concentration (Tmax) of MK-4082	Blood samples will be collected to determine the Tmax of MK-4082.	Predose and at designated timepoints up to 84 Days postdose
Maximum Plasma Concentration (Cmax) of MK-4082	Blood samples will be collected to determine the Cmax of MK-4082.	Predose and at designated timepoints up to 84 Days postdose
Plasma Concentration at 24 Hours (C24) of MK-4082	Blood samples will be collected to determine the 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	Blood samples will be collected to determine the AUC0-Inf of MK-4082.	Predose and at designated timepoints up to 84 Days postdose
Area Under the Curve from Time 0 to Last (AUC0-Last) of MK-4082	Blood samples will be collected to determine the AUC0-last of MK-4082.	Predose and at designated timepoints up to 84 Days postdose
Apparent Clearance (CL/F) of MK-4082	Blood samples will be collected to determine the CL/F of MK-4082.	Predose and at designated timepoints up to 84 Days postdose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-4082	Blood samples will be collected to determine the Vz/F of MK-4082.	Predose and at designated timepoints up to 84 Days postdose
Apparent Terminal Half-life (t1/2) of MK-4082	Blood samples will be collected to determine the t1/2of MK-4082.	Predose and at designated timepoints up to 84 Days postdose
Change from Baseline in Body Weight	Change from baseline in body weight will be reported.	Baseline and up to approximately 84 Days
Change from Baseline in Body Mass Index (BMI)	Change from baseline in body mass index (BMI) will be reported.	Baseline and up to approximately 84 Days

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2026
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): September 9, 2026

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 4082-002; MK-4082-002 (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