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CompletedNCT02754830Updated Oct 13, 2023Results posted

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

A Phase 1 interventional study of LY3303560 - IV and Saline Solution - IV in Alzheimer's Disease, sponsored by Eli Lilly and Company. Completed at 2 sites in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-13.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and tolerability of the study drug, LY3303560. Side effects and laboratory results will be monitored. This study will involve single doses of LY3303560 administered intravenously (IV), meaning into a vein or subcutaneously (SC), meaning under the skin.

Screening is required within 28 days before the start of the study for healthy participants and within 70 days before the start of the study for AD participants. The study requires about 16 weeks of each participant's time including a 4 day clinical research unit (CRU) admission and 10 follow-up appointments.

This is the first time that this study drug is being given to participants. This study is for research purposes only, and is not intended to treat any medical condition.

02

Conditions studied

  • Alzheimer's Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 72 is close to the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

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Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    LY3303560

    Single IV infusion 7 milligram (mg), 21 mg, 70 mg, 210 mg, 700 mg, 1400 mg, 2800 mg, and 5600 mg of LY3303560 on Day 1 in healthy participants.

    Drug: LY3303560 - IV

  • Placebo comparator
    Saline Solution

    Single IV infusion of saline solution to match LY3303560 on Day 1 in healthy participants.

    Drug: Saline Solution - IV

  • Experimental
    LY3303560 Subcutaneous (SC)

    Single SC injection of 210 mg LY3303560 on Day 1 in healthy participants.

    Drug: LY3303560 - SC

Interventions

  • DrugLY3303560 - IV

    Administered IV

  • DrugSaline Solution - IV

    Administered IV

  • DrugLY3303560 - SC

    Administered SC

06

What researchers measure

Primary outcomes

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

    Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of other nonserious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

    Time frame: Baseline up to 146 days

Secondary outcomes

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

    Serum PK: AUC. Statistical analysis was not pre-specified.

    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

  2. PK: Maximum Drug Concentration (Cmax) of LY3303560

    Serum PK: Cmax. Statistical analysis was not pre-specified.

    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

  3. 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

  4. 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

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

    Mean change from baseline in QT/QTc intervals using Fridericia's formula \[Fridericia's corrected QT(QTcF)\] from ECG monitoring.

    Time frame: Baseline, 7 days postdose

07

Results

Posted Sep 21, 2023
Limitations and caveats
Planned doses of 2800 mg and 5600 mg in AD participants were not implemented.

Participant flow

Participant flow — Overall Study
MilestonePlacebo7 mg LY330356021 mg LY330356070 mg LY3303560210 mg LY3303560210 mg LY3303560 Subcutaneous700 mg LY33035601400 mg LY33035602800 mg LY33035605600 mg LY3303560
Started17666666676
Completed17666666676
Not completed0000000000

Outcome measures

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

Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of other nonserious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Time frame:
Baseline up to 146 days
Reported as:
Count of participants · Participants
Number of Participants With One or More Serious Adverse Event(s) (SAEs) to be Related to Study Drug Administration
ParticipantsPlacebo7 mg LY330356021 mg LY330356070 mg LY3303560210 mg LY3303560210 mg LY3303560 SC700 mg LY33035601400 mg LY33035602800 mg LY33035605600 mg LY3303560
Number of Participants With One or More Serious Adverse Event(s) (SAEs) to be Related to Study Drug Administration0000000000
SecondaryPharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3303560

Serum PK: AUC. Statistical analysis was not pre-specified.

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
Reported as:
Geometric mean · microgram*hour per millliliter(µg*hr/mL)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3303560
microgram*hour per millliliter(µg*hr/mL)7 mg LY330356021 mg LY330356070 mg LY3303560210 mg LY3303560210 mg LY3303560 SC700 mg LY33035601400 mg LY33035602800 mg LY33035605600 mg LY3303560
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3303560863 ± 152570 ± 811300 ± 1627100 ± 1516700 ± 1798000 ± 34219000 ± 28325000 ± 25788000 ± 21
SecondaryPK: Maximum Drug Concentration (Cmax) of LY3303560

Serum PK: Cmax. Statistical analysis was not pre-specified.

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
Reported as:
Geometric mean · microgram/millliliter (µg/mL)
PK: Maximum Drug Concentration (Cmax) of LY3303560
microgram/millliliter (µg/mL)7 mg LY3303560 7mg21 mg LY330356070 mg LY3303560210 mg LY3303560210 mg LY3303560 SC700 mg LY33035601400 mg LY33035602800 mg LY33035605600 mg LY3303560
PK: Maximum Drug Concentration (Cmax) of LY33035602.78 ± 127.68 ± 2441.5 ± 5775.0 ± 2020.9 ± 18331 ± 18631 ± 251050 ± 302440 ± 21
SecondaryPharmacokinetics (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

No measurements were reported for this outcome.

SecondaryPharmacokinetics (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

No measurements were reported for this outcome.

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

Mean change from baseline in QT/QTc intervals using Fridericia's formula \[Fridericia's corrected QT(QTcF)\] from ECG monitoring.

Time frame:
Baseline, 7 days postdose
Reported as:
Mean · milliseconds (msec)
Mean Change From Baseline in QT/QT Corrected (QTc) Interval
milliseconds (msec)Placebo7 mg LY330356021 mg LY330356070 mg LY3303560210 mg LY3303560210 mg LY3303560 SC700 mg LY33035601400 mg LY33035602800 mg LY33035605600 mg LY3303560
Mean Change From Baseline in QT/QT Corrected (QTc) Interval2.5 ± 10.7-0.8 ± 14.8-1.0 ± 8.0-0.9 ± 4.0-0.5 ± 11.8-1.0 ± 14.7-1.4 ± 14.01.7 ± 15.25.5 ± 21.30.8 ± 10.9

Adverse events

Collected over Baseline up to 146 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/17 (0%)0/17 (0%)6/17 (35.3%)
7 mg LY33035600/6 (0%)0/6 (0%)1/6 (16.7%)
21 mg LY33035600/6 (0%)0/6 (0%)1/6 (16.7%)
70 mg LY33035600/6 (0%)0/6 (0%)1/6 (16.7%)
210 mg LY33035600/6 (0%)0/6 (0%)2/6 (33.3%)
210 mg LY3303560 SC0/6 (0%)0/6 (0%)2/6 (33.3%)
700 mg LY33035600/6 (0%)0/6 (0%)3/6 (50%)
1400 mg LY33035600/6 (0%)0/6 (0%)2/6 (33.3%)
2600 mg LY33035600/7 (0%)0/7 (0%)1/7 (14.3%)
5600 mg LY33035600/6 (0%)0/6 (0%)4/6 (66.7%)
Most frequent other events
Showing 10 of 32
Most frequent other events
EventPlacebo7 mg LY330356021 mg LY330356070 mg LY3303560210 mg LY3303560210 mg LY3303560 SC700 mg LY33035601400 mg LY33035602600 mg LY33035605600 mg LY3303560
Upper respiratory tract infectionInfections and infestations0/170/60/60/62/60/61/60/60/70/6
HeadacheNervous system disorders2/170/60/60/62/60/60/60/60/70/6
PalpitationsCardiac disorders0/170/60/60/60/60/60/61/60/70/6
Defaecation urgencyGastrointestinal disorders0/170/60/60/60/60/60/60/60/71/6
DiarrhoeaGastrointestinal disorders1/170/60/60/60/60/61/60/60/70/6
HaematocheziaGastrointestinal disorders0/170/60/60/60/60/61/60/60/70/6
Chest discomfortGeneral disorders0/170/60/60/60/60/61/60/60/70/6
Chest painGeneral disorders0/170/61/60/60/60/60/60/60/70/6
Influenza like illnessGeneral disorders0/170/61/60/60/60/60/61/60/70/6
SwellingGeneral disorders0/170/61/60/60/60/60/60/60/70/6

Baseline characteristics

All enrolled participants.

Age, Continuous
Age, Continuous(years)Placebo7 mg LY330356021 mg LY330356070 mg LY3303560210 mg LY3303560210 mg LY3303560 SC700 mg LY33035601400 mg LY33035602800 mg LY33035605600 mg LY3303560Total
Mean47.2 ± 9.041.8 ± 8.748.5 ± 10.749.8 ± 11.246.3 ± 10.346.2 ± 6.746.3 ± 12.247.0 ± 13.551.7 ± 9.640.7 ± 10.446.7 ± 9.9
Sex: Female, Male
Sex: Female, Male(Participants)Placebo7 mg LY330356021 mg LY330356070 mg LY3303560210 mg LY3303560210 mg LY3303560 SC700 mg LY33035601400 mg LY33035602800 mg LY33035605600 mg LY3303560Total
Female502321312322
Male1264345355350
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo7 mg LY330356021 mg LY330356070 mg LY3303560210 mg LY3303560210 mg LY3303560 SC700 mg LY33035601400 mg LY33035602800 mg LY33035605600 mg LY3303560Total
Hispanic or Latino02110110129
Not Hispanic or Latino1745565566463
Unknown or Not Reported00000000000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo7 mg LY330356021 mg LY330356070 mg LY3303560210 mg LY3303560210 mg LY3303560 SC700 mg LY33035601400 mg LY33035602800 mg LY33035605600 mg LY3303560Total
Japanese603331043326
Non-Japanese1163335624346
Region of Enrollment
Region of Enrollment(Participants)Placebo7 mg LY330356021 mg LY330356070 mg LY3303560210 mg LY3303560210 mg LY3303560 SC700 mg LY33035601400 mg LY33035602800 mg LY33035605600 mg LY3303560Total
United States1766666667672
08

Study locations

2 sites
  • Parexel Early Phase Unit at Glendale
    Glendale, California 91206, United States
  • PAREXEL-Phase 1 Baltimore Harbor Hospital Center
    Baltimore, Maryland 21225, United States
09

References and documents

Study documents

  • Study protocol · Jul 31, 2017
  • Statistical analysis plan · Apr 14, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02754830
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Apr 28, 2016
Start date
Apr 25, 2016
Primary completion
Jul 10, 2018
Completion
Jul 10, 2018
Results posted
Sep 21, 2023
Last update
Oct 13, 2023

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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