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MK-1403 + additive coformulation

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: May 29, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07242469A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)PHASE1 RECRUITING 52Dec 22, 2025Aug 28, 2026May 29, 20264 United States
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Study Endpoints
Primary Endpoints
Number of participants who experience one or more adverse events (AE)
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
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.

Secondary Endpoints
Change from Baseline in Placebo-Corrected High Sensitivity C-Reactive Protein (hsCRP) Serum Concentration
Baseline and 24-hours postdose on Day 14
Plasma concentration of MK-1403 at 24 Hours Postdose (C24) on Day 14
24-hour postdose on Day 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Panel A MK-1403 + additive coformulation dose 1EXPERIMENTALParticipants will receive MK-1403 + additive coformulation dose 1 orally once daily.
Panel A Placebo + additive coformulation dose 1PLACEBO_COMPARATORParticipants will receive Placebo + additive coformulation dose 1 orally once daily.
Panel B MK-1403 + additive coformulation dose 2EXPERIMENTALParticipants will receive MK-1403 + additive coformulation dose 2 orally once daily
Panel B Placebo + additive coformulation dose 2PLACEBO_COMPARATORParticipants will receive Placebo + additive coformulation dose 2 orally once daily
Interventions
NameTypeDescription
MK-1403 + additive coformulationDRUGMK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally.
Placebo + additive coformulationDRUGPlacebo + additive coformulation is a co-formulated product of placebo administered orally.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Has a confirmed diagnosis of Type 2 diabetes mellitus (T2DM) * Has body mass index (BMI) between 18 and 40 kg/m\^2, inclusive Exclusion Criteria: * Has Type 1 diabetes mellitus or secondary types of diabetes * Has a history of congestive heart failure (New York Heart Associa...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07242469lastUpdatePostDate: changed
LOWMay 29, 2026NCT07242469lastUpdatePostDate: changed
LOWMay 29, 2026NCT07242469lastUpdatePostDate: changed
LOWMay 26, 2026NCT07242469primaryCompletionDate: changed
LOWMay 24, 2026NCT07242469studyFirstPostDate: changed