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LY3154207

Phase 2

Lewy Body Dementia | Small molecule | Neurology |Eli Lilly and Company|Trials Updated: Jun 18, 2026

LY3154207 development status

Highest phase Phase 2
Registered trials 7 across 1 sponsor since Feb 2015

LY3154207 target and mechanism

ModalitySmall molecule

Also known as LY3154207 Capsule, Mevidalen

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment728

FDA Designations

No designations recorded

LY3154207 clinical trials

LY3154207 · 3 trials · 3 indications

Phase 2 2Phase 1 1
NCT06538116A Study of Mevidalen (LY3154207) in Participants With Alzheimer's DiseaseAlzheimer Disease
COMPLETED304 Analytics
NCT03305809A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)Lewy Body Dementia
COMPLETED344 Analytics
PHASE2COMPLETED
A Study of Mevidalen (LY3154207) in Participants With Alzheimer's Disease
Alzheimer DiseaseUnlock trial analytics
PHASE2COMPLETED
A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)
Lewy Body DementiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)
Baseline, Week 24

iADRS assesses the impact of cognitive loss on everyday activities and provides a measure of global AD severity as a single summary score. It comprises of 2 underlying domains "cognitive ability" and "functional ability," and integrates the items in both the domains a single overall score ranging from 0 to 144, with lower scores indicating worse performance.

Change From Baseline in the Continuity of Attention (CoA) Composite Score of the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB)
Baseline, Week 12

The CDR-CCB tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning which includes tests of attention (simple and choice reaction time, digit vigilance), working memory (spatial and numeric) and episodic memory (word recognition, picture recognition). Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerized battery tests. For continuity of attention, the score range is -999 to 35. A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. Data presented are model-based bayesian posterior mean response rates with 95% credible interval.

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through study completion (Day 15) in each part.

Secondary Endpoints

Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13)
Baseline, Week 24
Change from Baseline in Verbal Fluency Test
Baseline, Week 24
Change from Baseline in Category Fluency Test
Baseline, Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Mevidalen (high dose)EXPERIMENTALMevidalen high dose administered orally.
Mevidalen (low dose)EXPERIMENTALMevidalen low dose administered orally.
PlaceboPLACEBO_COMPARATORPlacebo administered orally.
10 milligram (mg) LY3154207EXPERIMENTALParticipants received 10 mg LY3154207 administered orally QD.
30 mg LY3154207EXPERIMENTALParticipants received 30 mg LY3154207 administered orally QD.
75 mg LY3154207EXPERIMENTALParticipants received 75 mg LY3154207 administered orally QD.
LY3154207EXPERIMENTALLY3154207 administered orally once daily in multiple-ascending dose cohorts for 14 days.

Interventions

NameTypeDescription
MevidalenDRUGAdministered orally
PlaceboDRUGAdministered orally
LY3154207DRUGAdministered orally.
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Eligibility Criteria

Age Range50 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites64

Inclusion Criteria: * Have gradual and progressive decline in memory function for greater than or equal to 6 months that is severe enough to interfere with activities of daily living. * Have MMSE score of 13 to 24. * Have eligibile plasma P-tau or historical evidence of AD pathology. * Have a relia...

Countries:United StatesJapanCanadaPuerto Rico
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Frequently asked questions about LY3154207

What is LY3154207?

LY3154207 is an investigational small molecule being developed by Eli Lilly and Company for neurological conditions. It has been studied in Lewy body dementia and Parkinson's disease. It is not approved and remains in clinical development.

What is LY3154207 used for?

LY3154207 has been studied for the treatment of dementia due to Lewy body dementia, including dementia associated with idiopathic Parkinson's disease and dementia with Lewy bodies. It is investigational and has not been approved for any indication.

Who makes LY3154207?

LY3154207 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the clinical trials evaluating the drug in Lewy body dementia and Parkinson's disease.

What phase is LY3154207 in?

LY3154207 has completed a Phase 2 clinical trial in Lewy body dementia and a Phase 1 trial in healthy participants and participants with Parkinson's disease. It is an investigational drug and has not been approved by the FDA.

What clinical trials is LY3154207 in?

LY3154207 has been evaluated in two completed trials. The Phase 2 trial NCT03305809 enrolled 344 participants with Lewy body dementia across the United States, Canada, and Puerto Rico. The Phase 1 trial NCT02562768 enrolled 80 healthy participants and participants with Parkinson's disease in the United States.

Is LY3154207 the same as LY3154207 Capsule?

Yes, LY3154207 Capsule is another name for LY3154207. Both refer to the same investigational small molecule developed by Eli Lilly and Company for Lewy body dementia and Parkinson's disease.