A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
Part of paid clinical trials in Chula Vista, California.
- Sponsor
- Merck Sharp & Dohme LLC
- Study ID
- NCT07242469
- Phase
- PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- MK-1403 + additive coformulation — DRUGMK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally.
- Placebo + additive coformulation — DRUGPlacebo + additive coformulation is a co-formulated product of placebo administered orally.
Study Details
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.
Key Dates
- Start date
- Dec 22, 2025
- Status verified
- May 2026
- Primary completion
- Aug 28, 2026
- Completion
- Aug 28, 2026
Study Design
- Enrollment
- 52 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Panel A MK-1403 + additive coformulation dose 1Participants will receive MK-1403 + additive coformulation dose 1 orally once daily.
- Placebo Comparator: Panel A Placebo + additive coformulation dose 1Participants will receive Placebo + additive coformulation dose 1 orally once daily.
- Experimental: Panel B MK-1403 + additive coformulation dose 2Participants will receive MK-1403 + additive coformulation dose 2 orally once daily
- Placebo Comparator: Panel B Placebo + additive coformulation dose 2Participants will receive Placebo + additive coformulation dose 2 orally once daily
Primary Outcome Measure
Number of participants who experience one or more adverse events (AE) [ Time Frame: Up to approximately 28 days ]
Central Contacts
- Toll Free Number1-888-577-8839
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| ProSciento Inc. ( Site 0001) | Chula Vista | California | 91911 | Study Coordinator 619-427-1300 |
| Advanced Pharma CR, LLC ( Site 0003) | Miami | Florida | 33147 | Study Coordinator 305-220-2727 |
| QPS-MRA, LLC ( Site 0004) | South Miami | Florida | 33143 | Study Coordinator 305-722-0970 |
| Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0005) | Springfield | Missouri | 65802 | - |
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