CompletedPhase 1Results posted

A Study of LY2886721 in Healthy Participants and Participants Diagnosed With Alzheimer's Disease

A Safety, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects and Patients Diagnosed With Alzheimer's Disease

Lead sponsor

Eli Lilly and Company

Asset

LY2886721

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 16-28•Background AD symptomatic therapy, if used: stable ≥4 weeks•Healthy volunteers

Primary endpoints

•Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721•Cmax of Plasma LY2886721•Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid

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 ID15107

Secondary IDI4O-EW-BACXEli Lilly and Company

NCT IDNCT01807026

Timeline

Milestones

Study start2013-03 (month precision)

Study first posted2013-03-08estimated

Primary completion2013-05actual (month precision)

Study completion2013-05actual (month precision)

Last update posted2019-07-19actual

Results first posted2019-07-19actual

Assets

Drug assets

LY2886721

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy participants have a body mass index (BMI) of 19 to 32 kilograms per square meter (kg/m^2), inclusive, at screening. There are no restrictions on BMI in participants diagnosed with Alzheimer's disease.

•Healthy participants should not be taking any concomitant medications. For participants with Alzheimer's disease, concomitant medications will be determined by the investigator in consultation with the Lilly clinical pharmacologist on an individual basis.

Cohort A:

•Participants are defined as otherwise healthy males or females as determined by medical history and physical examination, and a diagnosis of Alzheimer's disease and must be at least 45 years of age.

•Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease, as determined by a clinician approved by the sponsor or designee.

•Mini Mental State Examination (MMSE) score of 16 through 28 at screening.

•Modified Hachinski Ischemia Scale (MHIS) score of <4.

•Capable of understanding and signing their own informed consent, in the opinion of the investigator, or if the participant has a Legally Authorized Representative (LAR), then the LAR must be capable of understanding and signing the assent form, and the participant may or may not sign the informed consent, as to be determined by the investigator.

•If receiving concurrent treatment with an acetylcholinesterase inhibitor (AChEI) and/or memantine, the participant has been on a stable dose for at least 4 weeks before Day 1. Dosing must remain stable throughout the study. Note: If a participant has recently stopped ACHEIs and/or memantine, he or she must have discontinued treatment for at least 4 weeks before Day 1

Exclusion criteria

•Have an abnormality in the 12-lead electrocardiogram (ECG).

•Have abnormal blood pressure.

•Have abnormal thyroid function as reflected by thyroid stimulating hormone (TSH) values outside of the normal range.

•Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.

•Show evidence of hepatitis C and/or positive hepatitis C antibody.

•Have had multiple episodes of head trauma, or have a history within the last 5 years of a serious infectious disease affecting the brain.

•Have chronic hepatic disease.

•Have evidence or history of significant active bleeding or a coagulation disorder.

•Cohort A: have any neurological disorders other than Alzheimer's disease.

•For healthy participants (Cohorts B and C) only: Use or intend to use over the- counter or prescription medication, including herbal medications within 14 days prior to dosing or during 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

Safety / tolerability / PK

Amyloid biomarkers

Fluid / digital biomarkers

Amyloid biomarkers

4 endpoints

Primary/protocol endpoint

Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40

Time frame:Predose, up to 96 hours after administration of study drug

concentration, descriptive

Primary/protocol endpoint

PD: Cnadir of CSF Aβ 1-40

Time frame:Predose up to 36 hours after administration of study drug

concentration, descriptive

Primary/registry result

Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40

Time frame:Predose, up to 96 hours after administration of study drug

concentration, descriptive

Posted result

Group	Value (geometric_mean), picograms/milliliter (pg/mL)	Geometric coefficient of variation
Cohort A: 70 mg LY2886721n=10 Participants	22.2	35.2
Cohort A: Placebon=2 Participants	140	NA
Cohort B: 70 mg LY2886721n=10 Participants	19.5	11.9
Cohort C: 280 mg LY2886721n=9 Participants	11.0	42.2
Cohorts B and C: Placebon=5 Participants	162	7.39

Primary/registry result

PD: Cnadir of CSF Aβ 1-40

Time frame:Predose up to 36 hours after administration of study drug

concentration, descriptive

Posted result

Group	Value (geometric_mean), pg/mL	Geometric coefficient of variation
Cohort A: 70 mg LY2886721n=10 Participants	7600	30.7
Cohort A: Placebon=2 Participants	19500	NA
Cohort B: 70 mg LY2886721n=10 Participants	4480	110
Cohort B: Placebon=2 Participants	12500	NA

Fluid / digital biomarkers

4 endpoints

Primary/protocol endpoint

Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid (CSF) LY2886721

Time frame:Predose through 36 hours after administration of study drug

ratio, descriptive

Primary/protocol endpoint

Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721

Time frame:Predose through 36 hours after administration of study drug

concentration, descriptive

Primary/registry result

Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid (CSF) LY2886721

Time frame:Predose through 36 hours after administration of study drug

ratio, descriptive

Posted result

Group	Value (geometric_mean), ng*h/mL	Geometric coefficient of variation
Cohort A: 70 mg LY2886721n=10 Participants	458	16
Cohort B: 70 mg LY2886721n=10 Participants	410	16

Primary/registry result

Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721

Time frame:Predose through 36 hours after administration of study drug

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng/mL	Geometric coefficient of variation
Cohort A: 70 mg LY2886721n=10 Participants	24.0	18
Cohort B: 70 mg LY2886721n=10 Participants	24.4	19

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721

Time frame:Predose through 96 hours after administration of study drug

ratio, event

Primary/protocol endpoint

Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721

Time frame:Predose through 96 hours after administration of study drug

concentration, descriptive

Primary/registry result

Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721

Time frame:Predose through 96 hours after administration of study drug

ratio, event

Posted result

Group	Value (geometric_mean), nanogramshours/milliliter (ngh/mL)	Geometric coefficient of variation
Cohort A: 70 mg LY2886721n=10 Participants	2800	25
Cohort B: 70 mg LY2886721n=10 Participants	2580	20
Cohort C: 280 mg LY2886721n=9 Participants	10500	22

Primary/registry result

Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721

Time frame:Predose through 96 hours after administration of study drug

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanograms/milliliter (ng/mL)	Geometric coefficient of variation
Cohort A: 70 mg LY2886721n=10 Participants	183	41
Cohort B: 70 mg LY2886721n=10 Participants	180	17
Cohort C: 280 mg LY2886721n=9 Participants	888	11

Secondary/protocol endpoint

Cohort C: Mean QTcF Value at Cmax

Time frame:Predose up to 48 hours after administration of study drug

change from baseline, event

Secondary/registry result

Cohort C: Mean QTcF Value at Cmax

Time frame:Predose up to 48 hours after administration of study drug

change from baseline, event

Posted result

Group	Value (mean), milliseconds (ms)	Reported bounds
Cohort C: 280 mg LY2886721n=9 Participants	28.3	-23.4 - 33.2

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.