CompletedPhase 1Results posted

A Study of LY3002813 in Participants With Alzheimer's Disease

A Single-Dose and Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3002813 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease

Lead sponsor

Eli Lilly and Company

Asset

Donanemab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•MCI due to AD / mild-to-moderate AD•Amyloid biomarker required (PET)•Study partner/caregiver required•Healthy volunteers•MRI contraindications excluded

Primary endpoint

•Serious Adverse Events (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 ID15082

Secondary IDI5T-MC-AACCEli Lilly and Company

NCT IDNCT01837641

Timeline

Milestones

Study first posted2013-04-23estimated

Study start2013-05-03actual

Primary completion2016-08-24actual

Study completion2016-08-24actual

Last update posted2024-10-04actual

Results first posted2024-10-04actual

Assets

Drug assets

Donanemab

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy Participants:

-Overtly healthy males, as determined by medical history and physical examination, willing to use a reliable method of birth control and will not donate sperm during the study

-Between 18 to 40 years old.

-Body Mass Index (BMI) of between 18.0 and 30.0 kilogram per meter square (kg/m^2), inclusive

•Participants with Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or AD:

-Present with mild cognitive impairment (MCI) due to AD or mild-to-moderate AD

-Men or nonfertile women, at least 50 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year

-Have a caregiver/study informant who provides a separate written informed consent to participate

-Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator

-Positive florbetapir scan

Exclusion criteria

Healthy Participants: Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immunological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

•Participants with Mild Cognitive Impairment Due to AD or AD:

-Do not have a reliable caregiver/study informant who is in frequent contact with the participant, who will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications

-Are being monitored for radiation due to occupational exposure to ionized radiation, or exposure to ionizing radiation within last 12 months from an investigational study

-History within the past 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen post resection

•All Participants:

-History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy

-Have any contraindications for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of contraindicated metal (ferromagnetic) implants, cardiac pacemaker

-Have allergies to humanized monoclonal antibodies, including proteins and diphenhydramine, epinephrine, and methylprednisolone

-Have gamma globulin therapy within the last year

-Previously dosed in any other study investigating active immunization against amyloid beta (Aβ)

-Previously dosed in any other study investigating passive immunization against Aβ within the last 6 months

Endpoints (6)

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.

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

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

Time frame:Day 1 up to Day 253

event count, event

Primary/registry result

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

Time frame:Day 1 up to Day 253

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo IVn=12 Participants	1	-
0.1 mg/kg / 0.3 mg/kg LY3002813 IVn=4 Participants	0	-
0.3 mg/kg LY3002813 IVn=7 Participants	2	-
1 mg/kg LY3002813 IV: Healthy Participantsn=6 Participants	0	-
1 mg/kg LY3002813 IVn=9 Participants	1	-
3 mg/kg LY3002813 IVn=11 Participants	0	-
10 mg/kg LY3002813 IVn=6 Participants	0	-
3 mg/kg LY3002813 SCn=8 Participants	0	-

Secondary/protocol endpoint

Pharmacokinetics: Maximum Concentration (Cmax) of LY3002813

Time frame:Pre-dose, end of infusion for IV or 1h post injection for SC, 3, 24, 72, 96(SC), 120(SC), 144(SC), 168, 336, 504, 672, 1008, 1344, 1680 and 2016 hours (h) post-dose

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3002813

Time frame:Pre-dose, end of infusion for IV or 1h post injection for SC, 3, 24, 72, 96(SC), 120(SC), 144(SC), 168, 336, 504, 672, 1008, 1344, 1680 and 2016h post-dose

concentration, descriptive

Secondary/registry result

Pharmacokinetics: Maximum Concentration (Cmax) of LY3002813

Time frame:Pre-dose, end of infusion for IV or 1h post injection for SC, 3, 24, 72, 96(SC), 120(SC), 144(SC), 168, 336, 504, 672, 1008, 1344, 1680 and 2016 hours (h) post-dose

concentration, descriptive

Posted result

Group	Value (geometric_mean), microgram per milliliter (μg/mL)	Geometric coefficient of variation
0.1 mg/kg / 0.3 mg/kg LY3002813 IVn=4 Participants	2.90	35
0.3 mg/kg LY3002813 IVn=7 Participants	5.99	77
1 mg/kg LY3002813 IV: Healthy Participantsn=6 Participants	31.5	29
1 mg/kg LY3002813 IVn=9 Participants	21.7	21
3 mg/kg LY3002813 IVn=11 Participants	71.6	24
10 mg/kg LY3002813 IVn=6 Participants	218	16
3 mg/kg LY3002813 SCn=8 Participants	12.0	34

Secondary/registry result

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3002813

Time frame:Pre-dose, end of infusion for IV or 1h post injection for SC, 3, 24, 72, 96(SC), 120(SC), 144(SC), 168, 336, 504, 672, 1008, 1344, 1680 and 2016h post-dose

concentration, descriptive

Posted result

Group	Value (geometric_mean), microgramday per milliliter (μgday/mL)	Geometric coefficient of variation
0.1 mg/kg / 0.3 mg/kg LY3002813 IVn=4 Participants	7.94	32
0.3 mg/kg LY3002813 IVn=7 Participants	26.3	33
1 mg/kg LY3002813 IV: Healthy Participantsn=6 Participants	91.6	17
1 mg/kg LY3002813 IVn=9 Participants	79.9	26
3 mg/kg LY3002813 IVn=11 Participants	263	19
10 mg/kg LY3002813 IVn=6 Participants	1140	39
3 mg/kg LY3002813 SCn=8 Participants	157	41

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.