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MK-1167

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Merck & Company, Inc.|Trials Updated: Oct 14, 2025

MK-1167 development status

Highest phase Phase 2 (NCT06721156)
Phase scored for MRKPhase 1
Registered trials 6 across 1 sponsor since Feb 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

MK-1167 clinical trials

MK-1167 · 1 trial · 1 indication

Phase 1 1
NCT06285240Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007)Alzheimer's Disease
COMPLETED28 Analytics
PHASE1COMPLETED
Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007)
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Who Experienced an Adverse Event (AE)
Up to approximately 7 weeks

An AE was 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE were reported.

Number of Participants Who Discontinued Study Treatment Due to an AE
Up to approximately 4 weeks

An AE was 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE were reported.

Secondary Endpoints

Panel A: Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) After Administration of 6mg of MK-1167
Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel A: AUC0-24 After Administration of 3mg of MK-1167
Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Panel B: AUC0-24 After Administration of 6mg of MK-1167
Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Panel A: MK-1167 + Donepezil 10mg QDEXPERIMENTALParticipants receive 6mg MK-1167 oral loading doses once daily (QD) Days 1 to 7, followed by 3mg MK-1167 oral maintenance doses QD Days 8 to 21. Participants also receive 10mg oral Donepezil on Days -3 to 21.
Panel A: Placebo to MK-1167 + Donepezil 10mg QDPLACEBO_COMPARATORParticipants receive dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also receive 10mg oral Donepezil QD on Days -3 to 21.
Panel B: MK-1167 6mg QD + Donepezil 10mg QDEXPERIMENTALParticipants receive 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31.
Panel B: Placebo to MK-1167 + Donepezil 10mg QDPLACEBO_COMPARATORParticipants receive dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also receive 10mg oral Donepezil QD on Days -3 to 31.

Interventions

NameTypeDescription
MK-1167DRUG1 mg and 5 mg oral capsules
DonepezilDRUG10 mg oral tablets
PlaceboDRUGMK-1167 matching placebo administered oral capsules
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Eligibility Criteria

Age Range50 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Reports a history of cognitive and functional decline with gradual onset and slow progression for at least 1 year before Screening, that is either corroborated by an informant who knows the subject well or is documented in medical records * Meets the criteria for a diagnosis o...

Countries:United States
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Frequently asked questions about MK-1167

What is MK-1167?

MK-1167 is an investigational small molecule being developed by Merck & Company, Inc. (ticker MRK) for Alzheimer's disease dementia. It is in Phase 1 clinical development. The compound has been studied in a single completed trial that enrolled 28 participants in the United States.

What is MK-1167 used for in Alzheimer's Disease?

MK-1167 is being evaluated for the treatment of Alzheimer's disease dementia. The Phase 1 trial studied it in participants with Alzheimer's disease dementia who were taking stable donepezil treatment. It is investigational and has not been approved for any indication.

Who makes MK-1167?

MK-1167 is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 1 trial of MK-1167 in Alzheimer's disease dementia conducted in the United States.

What phase is MK-1167 in?

MK-1167 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.

What clinical trials is MK-1167 in?

MK-1167 has been studied in one completed Phase 1 trial, NCT06285240, titled Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007). The randomized, double-blind, placebo-controlled trial enrolled 28 participants in the United States.