Diabetes Mellitus, Type 2Phase 1NCT07242469
A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
A Phase 1 study testing MK-1403 + additive coformulation in people with Diabetes Mellitus, Type 2, run by Merck Sharp & Dohme LLC at 5 sites in United States.
Trial summary
The purpose of this study is to learn about the safety and if people tolerate a study medicine called MK-1403. The study will also measure what happens to MK-1403 in the body of a person with type 2 diabetes (T2D) over time (pharmacokinetic or PK study), and how it affects the amount of high-sensitivity C-reactive… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- MK-1403 + additive coformulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 5 sitesUnited States
- Study dates
- 22 Dec 2025to 2 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a confirmed diagnosis of Type 2 diabetes mellitus (T2DM)
- Has body mass index (BMI) between 18 and 40 kg/m^2, inclusive
Who cannot join
- Has Type 1 diabetes mellitus or secondary types of diabetes
- Has a history of congestive heart failure (New York Heart Association [NYHA] Class 3 or 4)
- Has history of myocardial infarction, uncontrolled arrhythmias, cardiac revascularization, angina, unstable peripheral arterial disease and/or stroke
- Has history of cancer (malignancy)
- Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV)
- Has a history of gastrointestinal (GI) disease which might affect food and drug absorption, or has had gastric bypass or similar surgery
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Anaheim Clinical Trials ( Site 0006)
Anaheim, California, 92801
ProSciento Inc. ( Site 0001)
Chula Vista, California, 91911
Advanced Pharma CR, LLC ( Site 0003)
Miami, Florida, 33147
QPS-MRA, LLC ( Site 0004)
South Miami, Florida, 33143
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0005)
Springfield, Missouri, 65802
About this study
Official title: A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1403 in Participants With Type 2 Diabetes Mellitus
The purpose of this study is to learn about the safety and if people tolerate a study medicine called MK-1403. The study will also measure what happens to MK-1403 in the body of a person with type 2 diabetes (T2D) over time (pharmacokinetic or PK study), and how it affects the amount of high-sensitivity C-reactive protein (hsCRP) in a person's blood.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- MK-1403 + additive coformulation, Placebo + additive coformulation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1403 + additive coformulationDrug
MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally.
Placebo + additive coformulationDrug
Placebo + additive coformulation is a co-formulated product of placebo administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Panel A MK-1403 + additive coformulation dose 1 | Experimental | Participants will receive MK-1403 + additive coformulation dose 1 orally once daily. Receives: Drug: MK-1403 + additive coformulation |
| Panel A Placebo + additive coformulation dose 1 | Placebo comparator | Participants will receive Placebo + additive coformulation dose 1 orally once daily. Receives: Drug: Placebo + additive coformulation |
| Panel B MK-1403 + additive coformulation dose 2 | Experimental | Participants will receive MK-1403 + additive coformulation dose 2 orally once daily Receives: Drug: MK-1403 + additive coformulation |
| Panel B Placebo + additive coformulation dose 2 | Placebo comparator | Participants will receive Placebo + additive coformulation dose 2 orally once daily Receives: Drug: Placebo + additive coformulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience one or more adverse events (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 one or more AEs will be reported.
Measured: Up to approximately 28 days
Number of participants who discontinue study intervention due to adverse events
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 14 days
Secondary outcomes (2)
Change from Baseline in Placebo-Corrected High Sensitivity C-Reactive Protein (hsCRP) Serum Concentration
Blood samples will be collected to determine the change from baseline in placebo-corrected hsCRP.
Measured: Baseline and 24-hours postdose on Day 14
Plasma concentration of MK-1403 at 24 Hours Postdose (C24) on Day 14
Blood samples will be collected to determine the C24 of MK-1403 in plasma on Day 14.
Measured: 24-hour postdose on Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start22 Dec 2025
- Primary completion2 Sep 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 53 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
- NCT07242469
- Sponsor's protocol ID
- 1403-006
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2025
- Last updated
- 15 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1403 in Participants With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07242469
- Acronym / sponsor ID
- 1403-006
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 2 Sep 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 21 Nov 2025 (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.
The purpose of this study is to learn about the safety and if people tolerate a study medicine called MK-1403. The study will also measure what happens to MK-1403 in the body of a person with type 2 diabetes (T2D) over time (pharmacokinetic or PK study), and how it affects the amount of high-sensitivity C-reactive protein (hsCRP) in a person's blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Panel A MK-1403 + additive coformulation dose 1 | Experimental | Drug: MK-1403 + additive coformulationParticipants will receive MK-1403 + additive coformulation dose 1 orally once daily. |
| Panel A Placebo + additive coformulation dose 1 | Placebo comparator | Drug: Placebo + additive coformulationParticipants will receive Placebo + additive coformulation dose 1 orally once daily. |
| Panel B MK-1403 + additive coformulation dose 2 | Experimental | Drug: MK-1403 + additive coformulationParticipants will receive MK-1403 + additive coformulation dose 2 orally once daily |
| Panel B Placebo + additive coformulation dose 2 | Placebo comparator | Drug: Placebo + additive coformulationParticipants will receive Placebo + additive coformulation dose 2 orally once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has a confirmed diagnosis of Type 2 diabetes mellitus (T2DM)
- Has body mass index (BMI) between 18 and 40 kg/m^2, inclusive
Key exclusion criteria (6 listed)
- Has Type 1 diabetes mellitus or secondary types of diabetes
- Has a history of congestive heart failure (New York Heart Association [NYHA] Class 3 or 4)
- Has history of myocardial infarction, uncontrolled arrhythmias, cardiac revascularization, angina, unstable peripheral arterial disease and/or stroke
- Has history of cancer (malignancy)
- Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV)
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-1403 + additive coformulationMK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally. | Drug | Panel A MK-1403 + additive coformulation dose 1, Panel B MK-1403 + additive coformulation dose 2 |
| Placebo + additive coformulationPlacebo + additive coformulation is a co-formulated product of placebo administered orally. | Drug | Panel A Placebo + additive coformulation dose 1, Panel B Placebo + additive coformulation dose 2 |
Primary outcome
Number of participants who experience one or more adverse events (AE)
Time frame: Up to approximately 28 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 one or more AEs will be reported.
Number of participants who discontinue study intervention due to adverse events
Time frame: Up to approximately 14 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.
2 secondary outcomes
Change from Baseline in Placebo-Corrected High Sensitivity C-Reactive Protein (hsCRP) Serum Concentration
Time frame: Baseline and 24-hours postdose on Day 14
Plasma concentration of MK-1403 at 24 Hours Postdose (C24) on Day 14
Time frame: 24-hour postdose on Day 14
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 15 Sep 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
5 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-1403 + additive coformulation in people with Diabetes Mellitus, Type 2, run by Merck Sharp & Dohme LLC at 5 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 2 inclusion and 6 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 15 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 5 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. Some participants in this study may receive a placebo. 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 one or more adverse events (AE) (time frame: Up to approximately 28 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 15 Sep 2026.