CompletedPhase 1Results posted

A Safety Study of LY2886721 Single Doses in Healthy Subjects

Single-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 (Adverse Events)

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 ID13733

Secondary IDI4O-MC-BACAEli Lilly and Company

NCT IDNCT01133405

Timeline

Milestones

Study first posted2010-05-28estimated

Study start2010-06 (month precision)

Primary completion2010-10actual (month precision)

Study completion2010-10actual (month precision)

Last update posted2019-09-16actual

Results first posted2019-09-16actual

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 nonchild-bearing potential women

•20 years or older

•Body mass index between 18-32 kilograms per square meter (kg/m^2)

Exclusion criteria

•Taking over-the-counter or prescription medication with the exception of vitamins or minerals or stable doses of thyroid or estrogen hormone replacement

•Smoke more than 10 cigarettes per day

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

Secondary/protocol endpoint

Pharmacodynamic Biomarker: Plasma Amyloid Beta (Aβ) 1-40 Concentration (Part 1 Only)

Time frame:0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose

concentration, descriptive

Secondary/protocol endpoint

Cerebrospinal Fluid (CSF) Pharmacodynamic Biomarker Amyloid Beta (Aβ) 1-40 Concentration (Part 2 Only)

Time frame:Predose and up to 36 hours postdose

concentration, descriptive

Secondary/registry result

Pharmacodynamic Biomarker: Plasma Amyloid Beta (Aβ) 1-40 Concentration (Part 1 Only)

Time frame:0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose

concentration, descriptive

Posted result

Group	Value (geometric_mean), picogram per milliliter (pg/mL)	Geometric coefficient of variation
Placebo (Part 1)n=19 Participants	121	23.6
1 mg LY2886721 (Part 1)n=8 Participants	80	19.5
7 mg LY2886721 (Part 1 - Fed and Fasted)n=6 Participants	56	41.3
15 mg LY2886721 (Part 1)n=6 Participants	35	37.7
25 mg LY2886721 (Part 1)n=7 Participants	34	28.4
35 mg LY2886721 (Part 1)n=6 Participants	36	11.7

Secondary/registry result

Cerebrospinal Fluid (CSF) Pharmacodynamic Biomarker Amyloid Beta (Aβ) 1-40 Concentration (Part 2 Only)

Time frame:Predose and up to 36 hours postdose

concentration, descriptive

Posted result

Group	Value (geometric_mean), picogram per milliliter (pg/mL)	Geometric coefficient of variation
10 mg LY2886721 (Part 2)n=4 Participants	8080	48.8
35 mg LY2886721 (Part 2)n=4 Participants	5650	51.1
Placebo (Part 2)n=4 Participants	7150	62.4

Fluid / digital biomarkers

4 endpoints

Secondary/protocol endpoint

Cerebrospinal Fluid (CSF) Maximum Observed Drug Concentration (Cmax) of LY2886721 (Part 2 Only)

Time frame:Predose and up to 36 hours postdose

concentration, descriptive

Secondary/protocol endpoint

Cerebrospinal Fluid (CSF) Area Under the Concentration Versus Time Curve (AUC) of LY2886721 (Part 2 Only)

Time frame:Predose and up to 36 hours postdose

concentration, descriptive

Secondary/registry result

Cerebrospinal Fluid (CSF) Maximum Observed Drug Concentration (Cmax) of LY2886721 (Part 2 Only)

Time frame:Predose and up to 36 hours postdose

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogram per milliliter (ng/mL)	Geometric coefficient of variation
10 mg LY2886721 (Part 2)n=4 Participants	0.93	60
35 mg LY2886721 (Part 2)n=4 Participants	5.99	39

Secondary/registry result

Cerebrospinal Fluid (CSF) Area Under the Concentration Versus Time Curve (AUC) of LY2886721 (Part 2 Only)

Time frame:Predose and up to 36 hours postdose

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramhour per milliliter (ngh/mL)	Geometric coefficient of variation
10 mg LY2886721 (Part 2)n=4 Participants	27	89
35 mg LY2886721 (Part 2)n=4 Participants	121	30

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Number of Participants With Clinically Significant Effects (Adverse Events)

Time frame:Predose to 10-14 days after final dose of study drug (up to 42 days)

event count, event

Primary/registry result

Number of Participants With Clinically Significant Effects (Adverse Events)

Time frame:Predose to 10-14 days after final dose of study drug (up to 42 days)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo (Part 1)Serious Adverse Eventsn=19 Participants	0	-
Other Nonserious Adverse Eventsn=19 Participants	4	-
1 mg LY2886721 (Part 1)Serious Adverse Eventsn=8 Participants	0	-
Other Nonserious Adverse Eventsn=8 Participants	2	-
7 mg LY2886721 (Part 1 - Fed and Fasted)Serious Adverse Eventsn=8 Participants	0	-
Other Nonserious Adverse Eventsn=8 Participants	1	-
10 mg LY2886721 (Part 2)Serious Adverse Eventsn=4 Participants	0	-
Other Nonserious Adverse Eventsn=4 Participants	1	-
15 mg LY2886721 (Part 1)Serious Adverse Eventsn=6 Participants	0	-
Other Nonserious Adverse Eventsn=6 Participants	0	-
25 mg LY2886721 (Part 1)Serious Adverse Eventsn=7 Participants	0	-
Other Nonserious Adverse Eventsn=7 Participants	1	-
35 mg LY2886721 (Part 1)Serious Adverse Eventsn=6 Participants	0	-
Other Nonserious Adverse Eventsn=6 Participants	3	-
35 mg LY2886721 (Part 2)Serious Adverse Eventsn=4 Participants	0	-
Other Nonserious Adverse Eventsn=4 Participants	4	-
Placebo (Part 2)Serious Adverse Eventsn=4 Participants	0	-
Other Nonserious Adverse Eventsn=4 Participants	3	-

Secondary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of LY2886721

Time frame:0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose

concentration, descriptive

Secondary/registry result

Maximum Observed Plasma Concentration (Cmax) of LY2886721

Time frame:0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogram per milliliter (ng/mL)	Geometric coefficient of variation
1 mg LY2886721 (Part 1)n=8 Participants	1.9	65
7 mg LY2886721 Fed (Part 1)n=5 Participants	22.5	23
7 mg LY2886721 Fasted (Part 1)n=6 Participants	18.2	64
10 mg LY2886721 (Part 2)n=4 Participants	6.6	60
15 mg LY2886721 (Part 1)n=6 Participants	41.6	24
25 mg LY2886721 (Part 1)n=7 Participants	79.1	25
35 mg LY2886721 (Part 1)n=6 Participants	78.2	45
35 mg LY2886721 (Part 2)n=4 Participants	53.3	44

Secondary/registry result

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

Time frame:0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramhour per milliliter (ngh/mL)	Geometric coefficient of variation
1 mg LY2886721 (Part 1)n=8 Participants	NA	NA
7 mg LY2886721 Fed (Part 1)n=5 Participants	311	14
7 mg LY2886721 Fasted (Part 1)n=6 Participants	212	41
10 mg LY2886721 (Part 2)n=4 Participants	144	580
15 mg LY2886721 (Part 1)n=6 Participants	468	20
25 mg LY2886721 (Part 1)n=7 Participants	926	16
35 mg LY2886721 (Part 1)n=6 Participants	954	37
35 mg LY2886721 (Part 2)n=4 Participants	800	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.