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 — DRUG
    MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally.
  • Placebo + additive coformulation — DRUG
    Placebo + 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 1
    Participants will receive MK-1403 + additive coformulation dose 1 orally once daily.
  • Placebo Comparator: Panel A Placebo + additive coformulation dose 1
    Participants will receive Placebo + additive coformulation dose 1 orally once daily.
  • Experimental: Panel B MK-1403 + additive coformulation dose 2
    Participants will receive MK-1403 + additive coformulation dose 2 orally once daily
  • Placebo Comparator: Panel B Placebo + additive coformulation dose 2
    Participants 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

Locations (4)

FacilityCityStateZIPSite coordinators
ProSciento Inc. ( Site 0001)Chula VistaCalifornia91911
Study Coordinator
619-427-1300
Advanced Pharma CR, LLC ( Site 0003)MiamiFlorida33147
Study Coordinator
305-220-2727
QPS-MRA, LLC ( Site 0004)South MiamiFlorida33143
Study Coordinator
305-722-0970
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0005)SpringfieldMissouri65802-

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