HealthyPhase 1NCT07388667
A Clinical Study of MK-4082 in Healthy Overweight Participants (MK-4082-002)
A Phase 1 study testing MK-4082 in people with Healthy, run by Merck Sharp & Dohme LLC at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-4082
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Mar 2026to 10 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
ProSciento Inc. ( Site 0002)
Chula Vista, California, 91911
Hassman Research Institute Marlton Site ( Site 0006)
Marlton, New Jersey, 08053
QPS-MRA, LLC ( Site 0003)
South Miami, Florida, 33143
Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0004)
Springfield, Missouri, 65802
About this study
Official title: 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
- Conditions
- Healthy
- Being tested
- MK-4082, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-4082Drug
Oral Tablet
PlaceboDrug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: MK-4082; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to approximately 84 Days
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and up to approximately 84 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start4 Mar 2026
- Primary completion1 Sep 2026
- Study completion10 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388667
- Sponsor's protocol ID
- 4082-002
- Other IDs
- MK-4082-002
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-4082 in Healthy Overweight/Obese Participants
- ClinicalTrials.gov ID
- NCT07388667
- Acronym / sponsor ID
- 4082-002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 10 Sep 2026 (actual)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Panel A: Dose Escalation to Dosage 1 | Experimental | Drug: MK-4082, Drug: PlaceboParticipants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 1. |
| Panel B: Dose Escalation to Dosage 2 | Experimental | Drug: MK-4082, Drug: PlaceboParticipants receive escalating doses of oral MK-4082 QD or a dose-matched placebo to reach maintenance dose 2. |
| Panel C: Dose Escalation to Dosage 3 | Experimental | Drug: MK-4082, Drug: PlaceboParticipants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 3. |
| Panel D: Dose Escalation to Dosage 4 | Experimental | Drug: MK-4082, Drug: PlaceboParticipants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 4. |
| Panel E: Dose Escalation to Dosage 5 | Experimental | Drug: MK-4082, Drug: PlaceboParticipants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 5. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health
- Has body mass index (BMI) between 25 and 40 kg/m^2, inclusive. Participants must weigh at least 60 kg
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-4082Oral Tablet | Drug | 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 |
| PlaceboOral Tablet | Drug | 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 |
Primary outcome
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 98 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.
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 84 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 treatment due to an AE will be reported.
11 secondary outcomes
Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-4082
Time frame: At designated timepoints (up to 24 hours postdose)
Time to Maximum Plasma Concentration (Tmax) of MK-4082
Time frame: Predose and at designated timepoints up to 84 Days postdose
Maximum Plasma Concentration (Cmax) of MK-4082
Time frame: Predose and at designated timepoints up to 84 Days postdose
Plasma Concentration at 24 Hours (C24) of MK-4082
Time frame: At designated timepoints up to 24 hours postdose
Area Under the Curve from Time 0 to Infinity (AUC0-Inf) of MK-4082
Time frame: Predose and at designated timepoints up to 84 Days postdose
Area Under the Curve from Time 0 to Last (AUC0-Last) of MK-4082
Time frame: Predose and at designated timepoints up to 84 Days postdose
Apparent Clearance (CL/F) of MK-4082
Time frame: Predose and at designated timepoints up to 84 Days postdose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-4082
Time frame: Predose and at designated timepoints up to 84 Days postdose
Apparent Terminal Half-life (t1/2) of MK-4082
Time frame: Predose and at designated timepoints up to 84 Days postdose
Change from Baseline in Body Weight
Time frame: Baseline and up to approximately 84 Days
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline and up to approximately 84 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-4082 in people with Healthy, run by Merck Sharp & Dohme LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 98 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.