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MK-1403+ additive coformulation

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Aug 17, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

MK-1403+ additive coformulation · 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
ACTIVE NOT_RECRUITING52 Analytics
PHASE1ACTIVE NOT_RECRUITING
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)

MEDIUMAug 17, 2026NCT07242469Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 17, 2026NCT07242469Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJul 31, 2026NCT07242469primaryCompletionDate: changed
LOWJul 31, 2026NCT07242469primaryCompletionDate: changed
LOWJul 13, 2026NCT07242469lastUpdatePostDate: changed
LOWJul 13, 2026NCT07242469lastUpdatePostDate: changed

Frequently asked questions about MK-1403+ additive coformulation

What is MK-1403 + additive coformulation used for?

MK-1403 + additive coformulation is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes MK-1403 + additive coformulation?

MK-1403 + additive coformulation is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate this investigational therapy.

What phase is MK-1403 + additive coformulation in?

MK-1403 + additive coformulation is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing trial is active but not recruiting participants.

What clinical trials is MK-1403 + additive coformulation in?

MK-1403 + additive coformulation is being studied in one active Phase 1 trial, NCT07242469, titled "A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)." This randomized, double-blind, placebo-controlled trial is enrolling 52 participants in the United States.

Is MK-1403 + additive coformulation the same as MK-1403?

MK-1403 + additive coformulation is also known as MK-1403 + additive coformulation. The trial title refers to MK-1403, and the coformulation includes an additive component. No other alternative names have been disclosed.