HealthyPhase 1NCT07697625
A Clinical Trial of MK-4082 in Healthy Participants (MK-4082-005)
A Phase 1 study testing MK-4082, Diltiazem and Rescue medication in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-4082, Diltiazem and Rescue medication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2026to 6 Oct 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 55 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
- Body mass index (BMI) between 18 and 32 kg/m^2, inclusive
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Anaheim Clinical Trials ( Site 0001)
Anaheim, California, 92801
About this study
Official title: A Clinical Study to Evaluate the Plasma Pharmacokinetics of a Single Dose of MK-4082 With and Without Diltiazem Coadministration in Healthy Participants
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
- Being tested
- MK-4082, Diltiazem, Rescue medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-4082Drug
Oral administration
DiltiazemDrug
Oral administration
Rescue medicationDrug
All participants will receive ondansetron as a rescue medication. Ondansetron is a medication used to prevent nausea or vomiting.
| Study group | Role | What they receive |
|---|---|---|
| MK-4082 | Experimental | 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. Receives: Drug: MK-4082; Drug: Diltiazem; Drug: Rescue medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of MK-4082
Blood samples will be collected to determine the AUC0-∞ of MK-4082.
Measured: At designated timepoints (up to approximately 1 week postdose)
Part 1: Maximum Plasma Concentration (Cmax) of MK-4082
Blood samples will be collected to determine the Cmax of MK-4082.
Measured: At designated timepoints (up to approximately 1 week postdose)
Part 1: 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 31 days
Part 1: Number of Participants Who Discontinue Study Intervention 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 intervention due to an AE will be reported.
Measured: Up to approximately 17 days
Secondary outcomes (6)
Part 2: AUC0-∞ of MK-4082
Blood samples will be collected to determine the AUC0-∞ of MK-4082.
Measured: At designated timepoints (up to approximately 1 week postdose)
Part 2: AUC0-24 of MK-4082
Blood samples will be collected to determine the AUC0-24 of MK-4082.
Measured: At designated timepoints (up to 24 hours postdose)
Part 2: Cmax of MK-4082
Blood samples will be collected to determine the Cmax of MK-4082.
Measured: At designated timepoints (up to approximately 1 week postdose)
Part 2: Time to maximum plasma concentration (Tmax) of MK-4082
Blood samples will be collected to determine the Tmax of MK-4082.
Measured: At designated timepoints (up to approximately 1 week postdose)
Part 2: Plasma concentration 24 hours postdose (C24) of MK-4082
Blood samples will be collected to determine the C24 of MK-4082.
Measured: 24 hours postdose
Part 2: Apparent terminal half-life (t½) of MK-4082
Blood samples will be collected to determine the t½ of MK-4082.
Measured: At designated timepoints (up to approximately 1 week postdose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start20 Jul 2026
- Primary completion6 Oct 2026
- Study completion6 Oct 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT07697625
- Sponsor's protocol ID
- 4082-005
- Other IDs
- MK-4082-005
- Status last verified
- Oct 2026
- First submitted
- 23 Jun 2026
- Last updated
- 2 Nov 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Plasma Pharmacokinetics of a Single Dose of MK-4082 With and Without Diltiazem Coadministration in Healthy Participants
- ClinicalTrials.gov ID
- NCT07697625
- Acronym / sponsor ID
- 4082-005
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 6 Oct 2026 (actual)
- Study completion
- 6 Oct 2026 (actual)
- First posted
- 13 Jul 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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MK-4082 | Experimental | Drug: MK-4082, Drug: Diltiazem, Drug: Rescue medicationParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health
- Body mass index (BMI) between 18 and 32 kg/m^2, inclusive
Key exclusion criteria (3 listed)
- 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
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 administration | Drug | MK-4082 |
| DiltiazemOral administration | Drug | MK-4082 |
| Rescue medicationAll participants will receive ondansetron as a rescue medication. Ondansetron is a medication used to prevent nausea or vomiting. | Drug | MK-4082 |
Primary outcome
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)
Blood samples will be collected to determine the AUC0-∞ of MK-4082.
Part 1: Maximum Plasma Concentration (Cmax) of MK-4082
Time frame: At designated timepoints (up to approximately 1 week postdose)
Blood samples will be collected to determine the Cmax of MK-4082.
Part 1: Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 31 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.
Part 1: Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to approximately 17 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 intervention due to an AE will be reported.
6 secondary outcomes
Part 2: AUC0-∞ of MK-4082
Time frame: At designated timepoints (up to approximately 1 week postdose)
Part 2: AUC0-24 of MK-4082
Time frame: At designated timepoints (up to 24 hours postdose)
Part 2: Cmax of MK-4082
Time frame: At designated timepoints (up to approximately 1 week postdose)
Part 2: Time to maximum plasma concentration (Tmax) of MK-4082
Time frame: At designated timepoints (up to approximately 1 week postdose)
Part 2: Plasma concentration 24 hours postdose (C24) of MK-4082
Time frame: 24 hours postdose
Part 2: Apparent terminal half-life (t½) of MK-4082
Time frame: At designated timepoints (up to approximately 1 week postdose)
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 2 Nov 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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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
1 site 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, Diltiazem and Rescue medication in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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)). The study lists 4 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 2 Nov 2026.