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CompletedPhase 1Results posted

A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease

Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3202626

Lead sponsor

Eli Lilly and Company

Asset

LY3202626

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•mild-to-moderate AD

Primary endpoint

•Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID15562

Secondary IDI7X-EW-LLCAEli Lilly and Company

NCT IDNCT02323334

Timeline

Milestones

Study start2014-12 (month precision)

Study first posted2014-12-23estimated

Primary completion2016-02actual (month precision)

Study completion2016-02actual (month precision)

Last update posted2021-04-19actual

Results first posted2021-04-19actual

Assets

Drug assets

LY3202626

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•For Parts A, B, and C, are overtly healthy males or females (nonchildbearing potential), as determined by medical history and physical examination

•Have a body mass index (BMI) of 18 to 32 kilograms per square meter (kg/m^2)

•For Part D, present with Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild to moderate AD

•Have venous access sufficient to allow for blood sampling

•Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and research unit policies

Exclusion criteria

•Taking over-the-counter or prescription medication with the exception of vitamins or minerals

•Smoke more than 10 cigarettes per day

•Are unwilling or unable to refrain from eating any food or drinking any beverage containing grapefruit or grapefruit juice for at least 2 weeks prior to first dose until completion of the study

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Amyloid biomarkers

Safety / tolerability / PK

Fluid / digital biomarkers

Amyloid biomarkers

6 endpoints

Secondary/protocol endpoint

Pharmacodynamic(PD) Biomarker: Plasma Minimum Amyloid-Beta Peptide (A-beta) 1-40 Concentration

Time frame:Part A Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 postdose; Part C Day 14: Predose 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 120, 168, and 216 postdose

concentration, descriptive

Secondary/protocol endpoint

PD Biomarker: Cerebral Spinal Fluid (CSF) Minimum Amyloid-beta Peptide (A-beta) 1-40 Concentration

Time frame:Part B: -4, -2, Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, and 36 hours postdose

concentration, descriptive

Secondary/protocol endpoint

PD Biomarker: Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid-beta Peptide (A-beta) 1-40 Concentration

Time frame:Parts C: Baseline, Day 15

change from baseline, improvement

Secondary/registry result

Pharmacodynamic(PD) Biomarker: Plasma Minimum Amyloid-Beta Peptide (A-beta) 1-40 Concentration

Time frame:Part A Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 postdose; Part C Day 14: Predose 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 120, 168, and 216 postdose

concentration, descriptive

Posted result

Group	Value (geometric_mean), Picogram per milliliter (pg/mL)	Geometric coefficient of variation
Part A Placebon=24 Participants	107	35.1
Part A 0.1mg LY3202626n=8 Participants	58.1	150
Part A 0.4mg LY3202626n=8 Participants	61.8	25.6
Part A 1.6 mg LY3202626n=8 Participants	33.4	62.0
Part A 5mg LY3202626n=8 Participants	25.2	16.8
Part A 15mg LY3202626n=8 Participants	17.0	33.6
Part A 45mg LY3202626n=8 Participants	7.93	42.0
Part C Placebon=9 Participants	84.6	26.5
Part C 1mg LY3202626 QDn=9 Participants	24.0	33.1
Part C 6mg LY3202626 QDn=9 Participants	5.80	51.9
Part C 26mg LY3202626 QDn=9 Participants	4.2	0

Secondary/registry result

PD Biomarker: Cerebral Spinal Fluid (CSF) Minimum Amyloid-beta Peptide (A-beta) 1-40 Concentration

Time frame:Part B: -4, -2, Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, and 36 hours postdose

concentration, descriptive

Posted result

Group	Value (geometric_mean), pg/mL	Geometric coefficient of variation
Part B Placebon=3 Participants	7980	53.8
Part B 1.6 mg LY3202626n=5 Participants	5700	22.3
Part B 6mg LY3202626n=5 Participants	5770	41.8
Part B 26mg LY3202626n=5 Participants	2980	46.4

Secondary/registry result

PD Biomarker: Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid-beta Peptide (A-beta) 1-40 Concentration

Time frame:Parts C: Baseline, Day 15

change from baseline, improvement

Posted result

Group	Value (mean), percent change in concentration	Standard deviation
Part C Placebon=9 Participants	-21.3	16.8
Part C 1mg LY3202626n=9 Participants	-50.1	8.56
Part C 6mg LY3202626n=9 Participants	-75.7	7.38
Part C 26mg LY3202626n=9 Participants	-93.7	2.39

Fluid / digital biomarkers

2 endpoints

Secondary/protocol endpoint

PK: CSF Concentration of LY3202626

Time frame:Part C: Day 15 at 24 hours +/- 4 hours (hr) postdose

concentration, descriptive

Secondary/registry result

PK: CSF Concentration of LY3202626

Time frame:Part C: Day 15 at 24 hours +/- 4 hours (hr) postdose

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng/mL	Geometric coefficient of variation
Part C 1mg LY3202626n=9 Participants	0.0648	46.2
Part C 6 mg LY3202626n=9 Participants	0.202	48.9
Part C 26mg LY3202626n=9 Participants	1.26	44.8

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame:Baseline to Study Completion (up to 14 weeks)

event count, event

Primary/registry result

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame:Baseline to Study Completion (up to 14 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Part A, B, and C Placebo (PBO)n=36 Participants	0	-
Part A 0.1mg LY3202626n=8 Participants	0	-
Part A 0.4mg LY3202626n=8 Participants	0	-
Part A 0.4mg LY3202626 + 200mg Itraconazolen=12 Participants	0	-
Part C 1mg LY3202626 QDn=9 Participants	0	-
Part A and B 1.6mg LY3202626n=13 Participants	0	-
Part A 5mg LY3202626n=8 Participants	0	-
Part C and D 6mg LY3202626 QDn=11 Participants	0	-
Part A, B and C 10mg LY3202626n=19 Participants	0	-
Part A 15mg LY3202626n=11 Participants	0	-
Part B and C 26mg LY3202626n=14 Participants	0	-
Part A 45mg LY3202626n=8 Participants	0	-

Secondary/protocol endpoint

Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3202626

Time frame:Part A and B Day 1:Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose; Part C Day 1:Predose, 0.5,1, 2, 4, 6, 8, and 12 hours postdose; Part C Day 14:Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 216 hours postdose

concentration, descriptive

Secondary/protocol endpoint

PK: Area Under the Concentration Time Curve (AUC) of LY3202626

Time frame:Part A and B Day 1: Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose; Part C Day 1:Presdose, 0.5,1, 2, 4, 6, 8,12 hours postdose; Day 14: Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 216 hours postdose

time to event, event

Secondary/registry result

Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3202626

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanograms per milliliter (ng/mL)	Geometric coefficient of variation
Part A 0.1mg LY3202626n=3 Participants	0.169	50
Part A 0.4mg LY3202626n=8 Participants	0.486	81
Part A 1.6mg LY3202626n=8 Participants	2.89	70
Part A 5mg LY3202626n=8 Participants	7.91	56
Part A 15mg LY3202626n=8 Participants	21.3	77
Part A 45mg LY3202626n=8 Participants	92.5	47
Part B 1.6mg LY3202626n=5 Participants	2.90	86
Part B 10mg LY3202626n=7 Participants	3.75	176
Part B 26mg LY3202626n=5 Participants	36.1	126
Part C 1mg LY3202626 QDn=8 Participants	2.57	2.5
Part C 6mg LY3202626 QDn=9 Participants	11.2	71
Part C 26mg LY3202626 QDn=9 Participants	72.8	61

Secondary/registry result

PK: Area Under the Concentration Time Curve (AUC) of LY3202626

time to event, event

Posted result

Group	Value (geometric_mean), nanogram x hour/milliliter (ng*hr/mL)	Geometric coefficient of variation
Part A 0.1mg LY3202626n=3 Participants	NA	NA
Part A 0.4mg LY3202626n=8 Participants	NA	NA
Part A 1.6mg LY3202626n=8 Participants	60.6	49
Part A 5mg LY3202626n=8 Participants	197	38
Part A 15mg LY3202626n=8 Participants	393	84
Part A 45mg LY3202626n=8 Participants	1680	34
Part B 1.6mg LY3202626n=5 Participants	49.9	41
Part B 10mg LY3202626n=7 Participants	102	111
Part B 26mg LY3202626n=5 Participants	575	62
Part C 1mg LY3202626 QDn=8 Participants	38.6	25
Part C 6mg LY3202626 QDn=9 Participants	151	54
Part C 26mg LY3202626 QDn=9 Participants	1020	50

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.