CompletedPhase 1Results posted

A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD

A Single- and Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Intravenous Doses 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

•mild-to-moderate AD•Amyloid biomarker required (PET)•MRI contraindications excluded•History of intracranial hemorrhage excluded

Primary endpoint

•Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio

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 ID16233

Secondary IDI5T-MC-AACDEli Lilly and Company

NCT IDNCT02624778

Timeline

Milestones

Study first posted2015-12-08estimated

Study start2015-12-22actual

Primary completion2019-08-28actual

Study completion2019-08-28actual

Last update posted2024-10-08actual

Results first posted2024-10-08actual

Assets

Drug assets

Donanemab

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Present with mild cognitive impairment (MCI) due to Alzheimer's disease (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 up to 2 partners who will provide 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

•Do not have up to 2 reliable partners who are 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 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

•Have current serious or unstable illnesses

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

Other (unclassified)

Amyloid biomarkers

2 endpoints

Primary/protocol endpoint

Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr)

Time frame:Baseline, Week 72

change from baseline, improvement

Primary/registry result

Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr)

Time frame:Baseline, Week 72

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), standard uptake value ratio (SUVr)	Standard error
Part A,B and C: Placebon=11 Participants	-0.050	0.04
Part A: 10 mg/kg LY3002813 SDn=6 Participants	-0.122	0.06
Part A: 20 mg/kg LY3002813 SDn=6 Participants	-0.183	0.06
Part A: 40 mg/kg LY3002813 SDn=1 Participants	-0.255	0.10
Part B: 10 mg/kg LY3002813 Q2Wn=9 Participants	-0.305	0.05
Part C:10 mg/kg LY3002813 Q4Wn=4 Participants	-0.419	0.06
Part C:20 mg/kg LY3002813 Q4Wn=4 Participants	-0.379	0.05

LS Mean-0.07195% CI-0.21 - 0.07p0.309Mixed Models Analysis

LS Mean-0.13395% CI-0.27 - 0.01p0.061Mixed Models Analysis

LS Mean-0.20595% CI-0.41 - 0.00p0.053Mixed Models Analysis

LS Mean-0.25595% CI-0.38 - -0.13p<0.001Mixed Models Analysis

LS Mean-0.36995% CI-0.51 - -0.23p<0.001Mixed Models Analysis

LS Mean-0.32995% CI-0.46 - -0.20p<0.001Mixed Models Analysis

Safety / tolerability / PK

10 endpoints

Secondary/protocol endpoint

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] in Part A

Time frame:Predose, end of infusion, 3, 24 and 48 hours postdose

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time at a Dosing Interval (AUCtau) at Day 1 of LY3002813 in Part B and Part C

Time frame:Predose, end of infusion, 3, 24, 48 and 72 hours postdose

concentration, descriptive

Secondary/protocol endpoint

PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813

Time frame:Part A: Predose, end of infusion, 3, 24 and 48 hours postdose; Part B and C: Predose, end of infusion, 3, 24, 48 and 72 hours postdose

concentration, descriptive

Secondary/protocol endpoint

PK: Maximum Serum Concentration (Cmax) of LY3002813 at Steady State of LY3002813 in Part B and C

Time frame:Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose

concentration, descriptive

Secondary/protocol endpoint

Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813

Time frame:Predose up to Day 589

threshold achievement, event

Secondary/registry result

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] in Part A

Time frame:Predose, end of infusion, 3, 24 and 48 hours postdose

concentration, descriptive

Posted result

Group	Value (geometric_mean), microgramhour per milliliter(μghr/mL)	Geometric coefficient of variation
Part A: 10 mg/kg LY3002813 SDn=7 Participants	25700	20
Part A: 20 mg/kg LY3002813 SDn=7 Participants	59400	19
Part A: 40 mg/kg LY3002813 SDn=4 Participants	110000	32

Secondary/registry result

Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time at a Dosing Interval (AUCtau) at Day 1 of LY3002813 in Part B and Part C

Time frame:Predose, end of infusion, 3, 24, 48 and 72 hours postdose

concentration, descriptive

Posted result

Group	Value (geometric_mean), microgramhour per milliliter (μghr/mL)	Geometric coefficient of variation
Part B: 10 mg/kg LY3002813 Q2Wn=9 Participants	23000	22
Part C:10 mg/kg LY3002813 Q4Wn=8 Participants	32900	35
Part C:20 mg/kg LY3002813 Q4Wn=10 Participants	58900	22

Secondary/registry result

PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813

Time frame:Part A: Predose, end of infusion, 3, 24 and 48 hours postdose; Part B and C: Predose, end of infusion, 3, 24, 48 and 72 hours postdose

concentration, descriptive

Posted result

Group	Value (geometric_mean), microgram per milliliter (μg/mL)	Geometric coefficient of variation
Part A: 10 mg/kg LY3002813 SDn=7 Participants	196	17
Part A: 20 mg/kg LY3002813 SDn=7 Participants	413	17
Part A: 40 mg/kg LY3002813 SDn=4 Participants	910	15
Part B: 10 mg/kg LY3002813 Q2Wn=9 Participants	223	19
Part C:10 mg/kg LY3002813 Q4Wn=8 Participants	252	31
Part C:20 mg/kg LY3002813 Q4Wn=10 Participants	564	26

Secondary/registry result

PK: Maximum Serum Concentration (Cmax) of LY3002813 at Steady State of LY3002813 in Part B and C

Time frame:Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose

concentration, descriptive

Posted result

Group	Value (geometric_mean), μg/mL	Geometric coefficient of variation
Part B: 10 mg/kg LY3002813 Q2Wn=4 Participants	273	23
Part C:10 mg/kg LY3002813 Q4Wn=6 Participants	366	44
Part C:20 mg/kg LY3002813 Q4Wn=7 Participants	598	23

Secondary/registry result

Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813

Time frame:Predose up to Day 589

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	Reported bounds
Part A,B and C: Placebon=15 Participants	13.3	-
10 mg/kg LY3002813 IV SDn=7 Participants	85.7	-
20 mg/kg LY3002813 IV SDn=7 Participants	100.0	-
40 mg/kg LY3002813 IV SDn=4 Participants	100.0	-
10 mg/kg LY3002813 IV Q2Wn=10 Participants	100.0	-
10 mg/kg LY3002813 IV Q4Wn=8 Participants	100.0	-
20 mg/kg LY3002813 IV Q4Wn=10 Participants	100.0	-

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

PK:Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3002813 in Part B and C

Time frame:Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose

concentration, descriptive

Secondary/registry result/low confidence

PK:Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3002813 in Part B and C

Time frame:Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose

concentration, descriptive

Posted result

Group	Value (geometric_mean), μg*hr/mL	Geometric coefficient of variation
Part B: 10 mg/kg LY3002813 Q2Wn=4 Participants	29700	68
Part C:10 mg/kg LY3002813 Q4Wn=6 Participants	35800	61
Part C:20 mg/kg LY3002813 Q4Wn=7 Participants	68400	37

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Gueorguieva I, Chow K, Chua L, Shcherbinin S, Zimmer JA, Evans CD, Wang H, Nery ESM, Brooks DA, Sims JR. Donanemab exposure-response in early symptomatic Alzheimer's disease. Alzheimers Dement. 2025 Jul;21(7):e70491. doi: 10.1002/alz.70491.
PMID40667684via DERIVED

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.