A Study of LY3372993 in Participants With Alzheimer's Disease (AD) and Healthy Participants
Primary Purpose
Alzheimer Disease, Healthy
Status
Active
Phase
Phase 1
Locations
International
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)
- Gradual and progressive changes in memory function reported by participants or their partners for greater than or equal to (≥) 6 months at screening, and a clinical diagnosis of mild cognitive impairment due to AD, or AD dementia, as determined by the investigator or based upon medical history
- Mini-Mental State Examination score ≥16
- Have clinical laboratory test results within normal reference range or results with acceptable deviations that are judged to be not clinically significant by the investigator
- Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to study visits or be available through telephone at designated times
(Part B)
- overtly healthy males or females
- have a body mass index of 18.0 to 32.0 kg/m2, inclusive
- To qualify as a participant of the first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
Exclusion Criteria:
(Part A)
- Have history or presence of uncontrolled asthma, significant autoimmune disease, hereditary angioedema, or known history of common variable immune deficiency
- Contraindication to positron emission tomography (PET)
- Have a history or presence of serious or unstable illnesses including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study, or increase risk for study intervention administration, or result in a participant's life expectancy of less than (<)24 months
- Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
- Have had significant medical history of dizziness, syncope, or vasovagal attacks within the past 3 years
- Contraindication to magnetic resonance imaging (MRI), including claustrophobia that cannot be managed with low-dose sedatives or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker
(Part B)
- have a family history of early onset AD (AD diagnosed prior to 65 years of age)
- have used or intend to use over-the-counter or prescription medication including herbal medications within 14 days prior to dosing.
- have a history or presence of significant psychiatric disorders
- have an abnormal blood pressure and/or pulse rate as determined by the investigator, or a pre-existing history of hypertension
- any clinically significant ECG or brain MRI abnormalities
Sites / Locations
- Altasciences Clinical Los Angeles, Inc
- Collaborative Neuroscience Research, LLC
- Accel Research Sites- Clinical Research Unit
- Velocity Clinical Research, Hallandale Beach
- IMIC, Inc.
- Ppd Development
- Progressive Medical Research
- BioClinica Inc
- Charter Research
- Covance Dallas
- Oita University Hospital
- The University of Tokyo Hospital
- Clinical Research Hospital Tokyo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
LY3372993 (Part A)
LY3372993 (Part B)
Placebo (Part A)
Placebo (Part B)
Arm Description
LY3372993 administered as multiple doses either intravenously (IV) or subcutaneously (SC).
LY3372993 administered as single dose IV or SC.
Placebo administered as multiple doses IV or SC.
Placebo administered as single dose IV or SC.
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): Maximum Concentration (Cmax) of LY3372993
PK: Cmax of LY3372993
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372993
PK: AUC of LY3372993
Pharmacodynamics (PD): Change from Baseline in Cerebral Amyloid Plaque Level (Part A only)
PD: Cerebral amyloid plaque level measured using florbetapir positron emission tomography
Full Information
NCT ID
NCT04451408
First Posted
June 26, 2020
Last Updated
September 29, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT04451408
Brief Title
A Study of LY3372993 in Participants With Alzheimer's Disease (AD) and Healthy Participants
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3372993 in Participants With Alzheimer's Disease and Healthy Participants
Study Type
Interventional
2. Study Status
Record Verification Date
September 15, 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
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 participants with AD, non-Japanese, and Japanese healthy participants who are of first-generation Japanese origin. The study will also investigate how much LY3372993 gets into the bloodstream and will test the effects of LY3372993. The study will be conducted in two parts. The part A includes participants with AD and part B includes healthy participants. Participation could last up to about 61 weeks and may include up to 31 visits to the study center.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
224 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LY3372993 (Part A)
Arm Type
Experimental
Arm Description
LY3372993 administered as multiple doses either intravenously (IV) or subcutaneously (SC).
Arm Title
LY3372993 (Part B)
Arm Type
Experimental
Arm Description
LY3372993 administered as single dose IV or SC.
Arm Title
Placebo (Part A)
Arm Type
Placebo Comparator
Arm Description
Placebo administered as multiple doses IV or SC.
Arm Title
Placebo (Part B)
Arm Type
Placebo Comparator
Arm Description
Placebo administered as single dose IV or SC.
Intervention Type
Drug
Intervention Name(s)
LY3372993
Intervention Description
Administered IV or SC.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered IV or SC.
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 through Week 61 (part A) and Week 13 (Part B)
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3372993
Description
PK: Cmax of LY3372993
Time Frame
Day 1 Predose through Week 61 (part A) and Week 13 (Part B)
Title
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372993
Description
PK: AUC of LY3372993
Time Frame
Day 1 Predose through Week 61 (part A) and Week 13 (Part B)
Title
Pharmacodynamics (PD): Change from Baseline in Cerebral Amyloid Plaque Level (Part A only)
Description
PD: Cerebral amyloid plaque level measured using florbetapir positron emission tomography
Time Frame
Baseline and Week 61 (part A)
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)
Gradual and progressive changes in memory function reported by participants or their partners for greater than or equal to (≥) 6 months at screening, and a clinical diagnosis of mild cognitive impairment due to AD, or AD dementia, as determined by the investigator or based upon medical history
Mini-Mental State Examination score ≥16
Have clinical laboratory test results within normal reference range or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to study visits or be available through telephone at designated times
(Part B)
overtly healthy males or females
have a body mass index of 18.0 to 32.0 kg/m2, inclusive
To qualify as a participant of the first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
Exclusion Criteria:
(Part A)
Have history or presence of uncontrolled asthma, significant autoimmune disease, hereditary angioedema, or known history of common variable immune deficiency
Contraindication to positron emission tomography (PET)
Have a history or presence of serious or unstable illnesses including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study, or increase risk for study intervention administration, or result in a participant's life expectancy of less than (<)24 months
Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
Have had significant medical history of dizziness, syncope, or vasovagal attacks within the past 3 years
Contraindication to magnetic resonance imaging (MRI), including claustrophobia that cannot be managed with low-dose sedatives or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker
(Part B)
have a family history of early onset AD (AD diagnosed prior to 65 years of age)
have used or intend to use over-the-counter or prescription medication including herbal medications within 14 days prior to dosing.
have a history or presence of significant psychiatric disorders
have an abnormal blood pressure and/or pulse rate as determined by the investigator, or a pre-existing history of hypertension
any clinically significant ECG or brain MRI abnormalities
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
Altasciences Clinical Los Angeles, Inc
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
Collaborative Neuroscience Research, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Accel Research Sites- Clinical Research Unit
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Velocity Clinical Research, Hallandale Beach
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
IMIC, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Ppd Development
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806-1041
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
Charter Research
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Covance Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States
Facility Name
Oita University Hospital
City
Yufu
State/Province
Oita
ZIP/Postal Code
879-5503
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Clinical Research Hospital Tokyo
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-0053
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/3qQDrJd2dTslGhNmqMga6Q
Description
A Study of LY3372993 in Participants With Alzheimer's Disease (AD)
Learn more about this trial
A Study of LY3372993 in Participants With Alzheimer's Disease (AD) and Healthy Participants
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