CompletedPhase 1Results posted

A Safety Study of LY2886721 Multiple Doses in Healthy Subjects

Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects

Lead sponsor

Eli Lilly and Company

Asset

LY2886721

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥20

Primary endpoint

•Clinically Significant Effects

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 ID13734

Secondary IDI4O-MC-BACBEli Lilly and Company

NCT IDNCT01227252

Timeline

Milestones

Study first posted2010-10-25estimated

Study start2010-12 (month precision)

Primary completion2011-04actual (month precision)

Study completion2011-04actual (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 age20 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy men and non-childbearing potential women

•Body mass index between 18.0-32.0 kilograms per square meter (kg/m^2)

•Are reliable and willing to make yourself 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

•Drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) per day

Endpoints (12)

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

Secondary/protocol endpoint

Plasma Amyloid Beta (Aβ) 1-40 Concentration

Time frame:Predose (Day 14) up to Day 19

concentration, descriptive

Secondary/protocol endpoint

Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration

Time frame:Predose (Day 14), 24 Hours post-dose (Day 15)

change from baseline, improvement

Secondary/registry result

Plasma Amyloid Beta (Aβ) 1-40 Concentration

Time frame:Predose (Day 14) up to Day 19

concentration, descriptive

Posted result

Group	Value (geometric_mean), picogram per milliliter (pg/mL)	Geometric coefficient of variation
Placebon=12 Participants	123	14.5
5 mg LY2886721n=9 Participants	49	55.1
15 mg LY2886721n=10 Participants	40	19.7
35 mg LY2886721n=10 Participants	25	28.1

Secondary/registry result

Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration

Time frame:Predose (Day 14), 24 Hours post-dose (Day 15)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percent change (%)	Reported bounds
Placebon=12 Participants	-3.9	--9.1 - 1.3
5 mg LY2886721n=10 Participants	-11.8	--16.1 - -7.4
15 mg LY2886721n=10 Participants	-27.5	--31.6 - -23.5
35 mg LY2886721n=10 Participants	-59.1	--67.0 - -51.1

Fluid / digital biomarkers

2 endpoints

Secondary/protocol endpoint

Cerebrospinal Fluid (CSF) Concentration of LY2886721

Time frame:24 Hours post-dose (Day 15)

concentration, descriptive

Secondary/registry result

Cerebrospinal Fluid (CSF) Concentration of LY2886721

Time frame:24 Hours post-dose (Day 15)

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogram per milliliter (ng/mL)	Geometric coefficient of variation
5 mg LY2886721n=4 Participants	0.5	64.5
15 mg LY2886721n=4 Participants	1.4	16.6
35 mg LY2886721n=4 Participants	3.8	22.6

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Number of Participants With Clinically Significant Effects

Time frame:Predose up to Day 70

event count, event

Primary/registry result

Number of Participants With Clinically Significant Effects

Time frame:Predose up to Day 70

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PlaceboSerious Adverse Eventsn=12 Participants	0	-
Nonserious Adverse Eventsn=12 Participants	2	-
5 mg LY2886721Serious Adverse Eventsn=10 Participants	0	-
Nonserious Adverse Eventsn=10 Participants	2	-
15 mg LY2886721Serious Adverse Eventsn=10 Participants	0	-
Nonserious Adverse Eventsn=10 Participants	3	-
35 mg LY2886721Serious Adverse Eventsn=10 Participants	0	-
Nonserious Adverse Eventsn=10 Participants	3	-

Secondary/protocol endpoint

Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721

Time frame:Predose (Day 14) up to Day 19

concentration, descriptive

Secondary/protocol endpoint

Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721

Time frame:Predose (Day 14) to 24 Hours post-dose (Day 15)

concentration, descriptive

Secondary/registry result

Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721

Time frame:Predose (Day 14) up to Day 19

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogram per milliliter (ng/mL)	Geometric coefficient of variation
5 mg LY2886721n=9 Participants	11.6	48
15 mg LY2886721n=10 Participants	43.0	24
35 mg LY2886721n=10 Participants	80.0	43

Secondary/registry result

Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721

Time frame:Predose (Day 14) to 24 Hours post-dose (Day 15)

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramhour per milliliter (ngh/mL)	Geometric coefficient of variation
5 mg LY2886721n=9 Participants	128	41
15 mg LY2886721n=10 Participants	447	23
35 mg LY2886721n=10 Participants	861	38

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.