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CompletedPhase 1Results posted

A Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD)

Single-Dose, Dose-Escalation Study With LY3303560 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Subjects and Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease

Asset

Zagotenemab

Listed sites

2

Recruiting sites

-

Enrollment

72

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)

Primary endpoint

•Serious Adverse Event(s) (SAEs) to be Related to Study Drug Administration

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 ID16120
Secondary IDI8G-MC-LMDAEli Lilly and Company
NCT IDNCT02754830

Timeline

Milestones

Study start2016-04-25actual
Study first posted2016-04-28estimated
Primary completion2018-07-10actual
Study completion2018-07-10actual
Results first posted2023-09-21actual
Last update posted2023-10-13actual

Assets

Drug assets

Zagotenemab

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age30 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Overtly healthy males or females of non-childbearing potential and who have given consent and are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
•AD participants must be at least 50 years of age and have diagnostic criteria consistent with either mild cognitive impairment due to AD or mild-to moderate AD and have a positive florbetapir positron emission tomography (PET) scan

Exclusion criteria

•Have known allergies to LY3303560, related compounds or any components of the formulation, or history of significant atopy
•Have an increased risk of seizures
•For AD participants, evidence of macrohemorrhage or greater than 4 microhemorrhage by magnetic resonance imaging (MRI)

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
6
Fluid / digital biomarkers
4
Other (unclassified)
2

Fluid / digital biomarkers

4 endpoints
Secondary/protocol endpoint

Pharmacokinetics (Cerebrospinal Fluid): Area Under the Concentration Versus Time Curve (AUC) of LY3303560 in Participants With Alzheimer's' Disease (AD)

Time frame:Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (Cerebrospinal Fluid): Maximum Drug Concentration (Cmax) of LY3303560 in Participants With Alzheimer's' Disease (AD)

Time frame:Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose

concentration, descriptive

Secondary/registry result

Pharmacokinetics (Cerebrospinal Fluid): Area Under the Concentration Versus Time Curve (AUC) of LY3303560 in Participants With Alzheimer's' Disease (AD)

Time frame:Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose

concentration, descriptive

Secondary/registry result

Pharmacokinetics (Cerebrospinal Fluid): Maximum Drug Concentration (Cmax) of LY3303560 in Participants With Alzheimer's' Disease (AD)

Time frame:Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose

concentration, descriptive

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

Number of Participants With One or More Serious Adverse Event(s) (SAEs) to be Related to Study Drug Administration

Time frame:Baseline up to 146 days

event count, event

Primary/registry result

Number of Participants With One or More Serious Adverse Event(s) (SAEs) to be Related to Study Drug Administration

Time frame:Baseline up to 146 days

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Placebon=17 Participants0-
7 mg LY3303560n=6 Participants0-
21 mg LY3303560n=6 Participants0-
70 mg LY3303560n=6 Participants0-
210 mg LY3303560n=6 Participants0-
210 mg LY3303560 SCn=6 Participants0-
700 mg LY3303560n=6 Participants0-
1400 mg LY3303560n=6 Participants0-
2800 mg LY3303560n=7 Participants0-
5600 mg LY3303560n=6 Participants0-
Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3303560

Time frame:Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdose

concentration, descriptive

Secondary/protocol endpoint

PK: Maximum Drug Concentration (Cmax) of LY3303560

Time frame:Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdose

concentration, descriptive

Secondary/registry result

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3303560

Time frame:Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdose

concentration, descriptive

Posted result

GroupValue (geometric_mean), microgram*hour per millliliter(µg*hr/mL)Geometric coefficient of variation
7 mg LY3303560n=6 Participants86315
21 mg LY3303560n=6 Participants25708
70 mg LY3303560n=6 Participants1130016
210 mg LY3303560n=6 Participants2710015
210 mg LY3303560 SCn=6 Participants1670017
700 mg LY3303560n=6 Participants9800034
1400 mg LY3303560n=6 Participants21900028
2800 mg LY3303560n=7 Participants32500025
5600 mg LY3303560n=6 Participants78800021
Secondary/registry result

PK: Maximum Drug Concentration (Cmax) of LY3303560

Time frame:Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdose

concentration, descriptive

Posted result

GroupValue (geometric_mean), microgram/millliliter (µg/mL)Geometric coefficient of variation
7 mg LY3303560 7mgn=6 Participants2.7812
21 mg LY3303560n=6 Participants7.6824
70 mg LY3303560n=6 Participants41.557
210 mg LY3303560n=6 Participants75.020
210 mg LY3303560 SCn=6 Participants20.918
700 mg LY3303560n=6 Participants33118
1400 mg LY3303560n=6 Participants63125
2800 mg LY3303560n=7 Participants105030
5600 mg LY3303560n=6 Participants244021

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Mean Change From Baseline in QT/QT Corrected (QTc) Interval

Time frame:Baseline, 7 days postdose

change from baseline, improvement

Secondary/registry result/low confidence

Mean Change From Baseline in QT/QT Corrected (QTc) Interval

Time frame:Baseline, 7 days postdose

change from baseline, improvement

Posted result

GroupValue (mean), milliseconds (msec)Standard deviation
Placebon=17 Participants2.510.7
7 mg LY3303560n=6 Participants-0.814.8
21 mg LY3303560n=6 Participants-1.08.0
70 mg LY3303560n=6 Participants-0.94.0
210 mg LY3303560n=6 Participants-0.511.8
210 mg LY3303560 SCn=6 Participants-1.014.7
700 mg LY3303560n=6 Participants-1.414.0
1400 mg LY3303560n=6 Participants1.715.2
2800 mg LY3303560n=7 Participants5.521.3
5600 mg LY3303560n=6 Participants0.810.9

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.