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MK-2225

Phase 1

Systemic Sclerosis | Small molecule | Immunology |Merck & Company, Inc.|Last Updated: Jul 29, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

MK-2225 · 1 trial · 1 indication

Phase 1 1
NCT06643390A Study of MK-2225 in Healthy Participants (MK-2225-003)Systemic Sclerosis
COMPLETED32 Analytics
PHASE1COMPLETED
A Study of MK-2225 in Healthy Participants (MK-2225-003)
Systemic SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 20 weeks

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 an AE will be reported.

Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 8 weeks

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/study treatment due to an AE will be reported.

Secondary Endpoints

Maximum Plasma Concentration (Cmax) of MK-2225
At designated timepoints (up to approximately 16 weeks)
Lowest Plasma Concentration (Ctrough) of MK-2225
At designated timepoints (up to approximately 16 weeks)
Time to Maximum Plasma Concentration (Tmax) of MK-2225
At designated timepoints (up to approximately 16 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK-2225 Panel AEXPERIMENTALParticipants receive MK-2225 Dose 1 subcutaneously (SQ) once every 2 weeks (Q2W) over the course of 8 weeks.
MK-2225 Panel BEXPERIMENTALParticipants receive MK-2225 Dose 2 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose.
MK-2225 Panel CEXPERIMENTALParticipants receive MK-2225 Dose 3 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose.
MK-2225 Panel DEXPERIMENTALParticipants receive MK-2225 Dose 4 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose.
PlaceboPLACEBO_COMPARATORParticipants receive placebo SQ Q2W over the MK-2225-matched time period.

Interventions

NameTypeDescription
MK-2225DRUGSubcutaneous administration
PlaceboOTHERSubcutaneous administration
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health before randomization * Body Mass Index (BMI) ≤32 kg/m\^2, inclusive Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * History of clinical...

Countries:United States
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Frequently asked questions about MK-2225

What is MK-2225 used for?

MK-2225 is an investigational small molecule being developed for systemic sclerosis, a condition characterized by fibrosis and vascular damage. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and tolerability in clinical trials.

Who makes MK-2225?

MK-2225 is being developed by Merck & Company, Inc., a global biopharmaceutical company. Merck is conducting clinical trials to evaluate the safety and tolerability of MK-2225 in healthy participants, as part of its early-stage research into treatments for systemic sclerosis.

What phase is MK-2225 in?

MK-2225 is in Phase 1 clinical development. This early-stage trial is designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers. The drug is investigational and has not yet been approved for any use, as it is still undergoing clinical evaluation.

What clinical trials is MK-2225 in?

MK-2225 has one completed Phase 1 clinical trial, identified as NCT06643390. This study, titled 'A Study of MK-2225 in Healthy Participants (MK-2225-003)', enrolled 32 participants in the United States. It was a randomized, double-blind, placebo-controlled trial involving healthy volunteers aged 18 years and older.

Is MK-2225 FDA approved?

No, MK-2225 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial was a safety and tolerability study in healthy participants, and the drug has not yet progressed through the later phases of clinical testing required for regulatory approval.