Back to resultsA Study of LY3372993 in Healthy Participants and Participants With Alzheimer's Disease (AD)
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3372993
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria :
Part A:
- Overtly healthy males or females as determined by medical history and physical examination
- Are between 18 to 45 years old, inclusive
- Male participants agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product
- Female participants not of child-bearing potential
- Have a body mass index of 18.0 to 32 kilograms per square meter (kg/m²) inclusive
Part B:
- Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild-to-moderate AD
- Positive florbetapir scan
- Men or nonfertile women, at least 55 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year
- Have up to 2 study partners who can provide health information related to the study about the participant. Study partner(s) will provide a separate written informed consent to participate
Exclusion Criteria:
- Have significant abnormalities in brain magnetic resonance imaging (MRI); or have contraindications for MRI
- Have significant allergic reactions to LY3372993, or related compounds, or have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
- Have clinically significant neurological or psychological illness, or other illnesses that could affect the study results
Part A:
- Have family history of early onset Alzheimer's Disease (AD)
- Have impaired cognitive function
Part B:
- History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy
- 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
Sites / Locations
- Collaborative Neuroscience Network - CNS
- Covance Clinical Research Inc
- Avail Clinical Research LLC
- MD Clinical
- BioClinica Inc
- IMIC, Inc.
- Progressive Medical Research
- BioClinica Inc
- Atlanta Center of Medical Research
- Carolina Phase 1 Research (Wake M3)
- PRA Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
LY3372993 (Part A)
Placebo (Part A)
LY3372993 (Part B)
Placebo (Part B)
Arm Description
LY3372993 administered intravenously (IV) to healthy participants.
Placebo administered IV to healthy participants.
LY3372993 administered IV to participants with AD. Part B was terminated before any participants received treatment.
Placebo administered IV to participants with AD. Part B was terminated before any participants received treatment.
Outcomes
Primary Outcome Measures
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcome Measures
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3372993 After a Single Dose
PK: AUC of LY3372993 After a Single Dose
PK: Maximum Observed Concentration (Cmax) of LY3372993 After a Single Dose
PK: Cmax of LY3372993 After a Single Dose
PK: AUC of LY3372993 at Steady State after Multiple Doses
PK: AUC of LY3372993 at Steady State after Multiple Doses
PK: Cmax of LY3372993 at Steady State After Multiple Doses
PK: Cmax of LY3372993 at Steady State After Multiple Doses
Pharmacodynamics (PD): Change from Baseline in Amyloid Load
Amyloid load measured by florbetapir F18 positron emission tomography (PET) scan
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03720548
Brief Title
A Study of LY3372993 in Healthy Participants and Participants With Alzheimer's Disease (AD)
Official Title
A Single-Dose and Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3372993 in Healthy Subjects and Patients With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 1, 2019
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
May 14, 2019 (Actual)
Study Completion Date
May 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in healthy participants and participants with AD. The study will also investigate how much LY3372993 gets into the bloodstream and test the effects of LY3372993 in participants with AD.
The study has two parts:
Part A - Healthy participants will receive LY3372993 or placebo. Part A will last up to 17 weeks;
Part B - Participants with AD will receive LY3372993 or placebo. Part B will last about 317 days.
Detailed Description
In April, 2019, Eli Lilly and Company made a business decision to terminate Part B. No participants were enrolled.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY3372993 (Part A)
Arm Type
Experimental
Arm Description
LY3372993 administered intravenously (IV) to healthy participants.
Arm Title
Placebo (Part A)
Arm Type
Placebo Comparator
Arm Description
Placebo administered IV to healthy participants.
Arm Title
LY3372993 (Part B)
Arm Type
Experimental
Arm Description
LY3372993 administered IV to participants with AD. Part B was terminated before any participants received treatment.
Arm Title
Placebo (Part B)
Arm Type
Placebo Comparator
Arm Description
Placebo administered IV to participants with AD. Part B was terminated before any participants received treatment.
Intervention Type
Drug
Intervention Name(s)
LY3372993
Intervention Description
Administered IV.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered IV.
Primary Outcome Measure Information:
Title
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Description
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time Frame
Baseline up to Day 562
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3372993 After a Single Dose
Description
PK: AUC of LY3372993 After a Single Dose
Time Frame
Predose up to Day 85
Title
PK: Maximum Observed Concentration (Cmax) of LY3372993 After a Single Dose
Description
PK: Cmax of LY3372993 After a Single Dose
Time Frame
Predose up to Day 85
Title
PK: AUC of LY3372993 at Steady State after Multiple Doses
Description
PK: AUC of LY3372993 at Steady State after Multiple Doses
Time Frame
Week 14 through Week 18
Title
PK: Cmax of LY3372993 at Steady State After Multiple Doses
Description
PK: Cmax of LY3372993 at Steady State After Multiple Doses
Time Frame
Week 14 through Week 18
Title
Pharmacodynamics (PD): Change from Baseline in Amyloid Load
Description
Amyloid load measured by florbetapir F18 positron emission tomography (PET) scan
Time Frame
Baseline, Week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria :
Part A:
Overtly healthy males or females as determined by medical history and physical examination
Are between 18 to 45 years old, inclusive
Male participants agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product
Female participants not of child-bearing potential
Have a body mass index of 18.0 to 32 kilograms per square meter (kg/m²) inclusive
Part B:
Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild-to-moderate AD
Positive florbetapir scan
Men or nonfertile women, at least 55 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year
Have up to 2 study partners who can provide health information related to the study about the participant. Study partner(s) will provide a separate written informed consent to participate
Exclusion Criteria:
Have significant abnormalities in brain magnetic resonance imaging (MRI); or have contraindications for MRI
Have significant allergic reactions to LY3372993, or related compounds, or have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
Have clinically significant neurological or psychological illness, or other illnesses that could affect the study results
Part A:
Have family history of early onset Alzheimer's Disease (AD)
Have impaired cognitive function
Part B:
History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Collaborative Neuroscience Network - CNS
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Covance Clinical Research Inc
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Avail Clinical Research LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
BioClinica Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
IMIC, Inc.
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
BioClinica Inc
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Atlanta Center of Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Carolina Phase 1 Research (Wake M3)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PRA Health Sciences
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of LY3372993 in Healthy Participants and Participants With Alzheimer's Disease (AD)
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