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MK-1403

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Merck & Company, Inc.|Trials Updated: Sep 15, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

MK-1403 clinical trials

MK-1403 · 1 trial · 1 indication

Phase 1 1
NCT07242469A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)Diabetes Mellitus, Type 2
COMPLETED53 Analytics
PHASE1COMPLETED
A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
Diabetes Mellitus, Type 2Unlock trial analytics

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 to 75 Years
SexALL
Healthy VolunteersNo
Study Sites5

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)

MEDIUMOct 16, 2026NCT07242469TRIAL_REMOVED: changed
MEDIUMOct 16, 2026NCT07242469TRIAL_REMOVED: changed
MEDIUMOct 16, 2026NCT07242469TRIAL_REMOVED: changed
MEDIUMOct 16, 2026NCT07242469TRIAL_REMOVED: changed
HIGHSep 16, 2026NCT07242469Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHSep 16, 2026NCT07242469Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHSep 16, 2026NCT07242469Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHSep 16, 2026NCT07242469Status: ACTIVE_NOT_RECRUITING → COMPLETED
MEDIUMAug 17, 2026NCT07242469Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 17, 2026NCT07242469Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJul 31, 2026NCT07242469primaryCompletionDate: changed
LOWJul 31, 2026NCT07242469primaryCompletionDate: changed

Frequently asked questions about MK-1403

What is MK-1403 used for?

MK-1403 is being developed for the treatment of type 2 diabetes mellitus. It is an investigational small molecule that Merck & Company, Inc. is studying in adults with the condition. It has not been approved for any use and remains in clinical development.

Who is developing MK-1403?

MK-1403 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck is the sponsor of the clinical program evaluating the drug in type 2 diabetes mellitus.

What phase is MK-1403 in?

MK-1403 is in Phase 1 clinical development. The program has completed one Phase 1 trial in participants with type 2 diabetes mellitus. MK-1403 is investigational and has not been approved by the FDA or any other regulatory authority.

What clinical trials is MK-1403 in?

MK-1403 has been studied in one Phase 1 trial, NCT07242469, titled A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006). The trial enrolled 53 participants in the United States, was randomized, double blind, and placebo controlled, and is now completed.

How many people were enrolled in the MK-1403 trial?

The Phase 1 trial of MK-1403, NCT07242469, enrolled 53 participants with type 2 diabetes mellitus. Enrollment was limited to adults 18 years and older in the United States, and healthy volunteers were not included. The study was randomized, double blind, and placebo controlled.