Back to resultsA Study of LY2599666 in Healthy Participants and Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD)
Primary Purpose
Healthy, Alzheimer's Disease, Mild Cognitive Impairment
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY2599666
Solanezumab
Placebo SC
Placebo IV
Sponsored by
About this trial
This is an interventional treatment trial for Healthy
Eligibility Criteria
Inclusion Criteria:
Healthy Participants Part A:
- Overtly healthy males or females as determined by medical history and physical examination
- Have a body mass index (BMI) between 18.0 and 32.0 kilograms per meter squared (kg/m²), inclusive
Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part B and C]:
- Participants are at least 50 years old at screening
- Present with Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild-to-moderate AD
- Have a caregiver/study informant who provides 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:
All Participants
- Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have known allergies to LY2599666, solanezumab, or any related compounds or components of the formulations, or have a history of significant atopy
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- Have an abnormal blood pressure as determined by the investigator
- Have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisone
- Require treatment with other monoclonal antibodies
Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part B and C]
- Have medical or surgical conditions in which lumbar puncture and or/catheter insertion is contraindicated
- Have any contraindication for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI
Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part C]
- Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen post treatment
Sites / Locations
- Parexel Early Phase Unit at Glendale
- CRI Lifetree
- PRA Health Sciences
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
LY2599666 (Part A)
Placebo (Part A)
LY2599666 (Part B)
Placebo (Part B)
Solanezumab (Part C)
Placebo (Part C)
Arm Description
LY2599666 given subcutaneously (SC) once.
Placebo matching LY2599666 given SC once.
LY2599666 given SC once weekly for 12 weeks (13 doses).
Placebo given SC once weekly for 12 weeks (13 doses).
Solanezumab given intravenously (IV) once weekly or once every 4 weeks for 12 weeks.
Placebo given IV once weekly or once every 4 weeks for 12 weeks.
Outcomes
Primary Outcome Measures
Number of Participants With One or More Serious Adverse Event (SAE) Considered by the Investigator to be Related to Study Drug Administration
Number of participants who experienced one or more treatment-emergent serious adverse events related to study treatment. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Secondary Outcome Measures
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part A
PK: Cmax of LY2599666 after a single dose administered subcutaneously.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part B
PK: Cmax of LY2599666 after multiple doses administered subcutaneously.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-∞) of LY2599666 Part A
Area Under the Concentration versus Time Curve of zero to infinity (0 to ∞) after a single dose of LY2599666 administered subcutaneously.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 168 Hours (AUC 0-168) of LY2599666 Part B
Area Under the Concentration time versus curve from 0-168 hours after weekly dose of LY2599666 administered subcutaneously.
Plasma Amyloid Beta1-40 (Aβ1-40 ) Concentration Part A
Concentration of plasma amyloid beta 1-40 in healthy participants after single dose of LY2599666 administered subcutaneously.
Plasma Amyloid Beta (Aβ1-40 and Aβ1-42) Concentration Part B
Concentration of plasma amyloid beta 1-40 and 1-42, in participants with Mild Cognitive Impairment (MCI) or Alzheimer Disease, after multiple doses of LY2599666 administered subcutaneously.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02614131
Brief Title
A Study of LY2599666 in Healthy Participants and Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD)
Official Title
Single-Dose and Multiple-Dose, Dose-Escalation Study With LY2599666 to Evaluate the Safety, Pharmacokinetics, and Tolerability in Healthy Subjects and Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild-to-Moderate Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
New data suggests that insufficient target engagement would be achieved for efficacy.
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY2599666 in different groups of people - those who are healthy, those who have mild cognitive impairment due to Alzheimer's Disease (AD), and those with mild-to-moderate AD. The study will measure how much LY2599666 gets into the bloodstream and how long it takes the body to get rid of it. It will also evaluate how LY2599666 affects the body. The study has three parts. Part A will last about 2 months. Parts B and C will each last about 23 weeks. Participants may only enroll in one part.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Alzheimer's Disease, Mild Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY2599666 (Part A)
Arm Type
Experimental
Arm Description
LY2599666 given subcutaneously (SC) once.
Arm Title
Placebo (Part A)
Arm Type
Placebo Comparator
Arm Description
Placebo matching LY2599666 given SC once.
Arm Title
LY2599666 (Part B)
Arm Type
Experimental
Arm Description
LY2599666 given SC once weekly for 12 weeks (13 doses).
Arm Title
Placebo (Part B)
Arm Type
Placebo Comparator
Arm Description
Placebo given SC once weekly for 12 weeks (13 doses).
Arm Title
Solanezumab (Part C)
Arm Type
Experimental
Arm Description
Solanezumab given intravenously (IV) once weekly or once every 4 weeks for 12 weeks.
Arm Title
Placebo (Part C)
Arm Type
Placebo Comparator
Arm Description
Placebo given IV once weekly or once every 4 weeks for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
LY2599666
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Solanezumab
Other Intervention Name(s)
LY2062430
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Placebo SC
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo IV
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Number of Participants With One or More Serious Adverse Event (SAE) Considered by the Investigator to be Related to Study Drug Administration
Description
Number of participants who experienced one or more treatment-emergent serious adverse events related to study treatment. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time Frame
Baseline through 4 weeks (Part A) or 16 weeks (Part B )
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part A
Description
PK: Cmax of LY2599666 after a single dose administered subcutaneously.
Time Frame
Day 1: Pre-dose and 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 504, 672 hours post-dose (Part A)
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part B
Description
PK: Cmax of LY2599666 after multiple doses administered subcutaneously.
Time Frame
Day 85: Pre-dose, 2, 4, 8, 12, 24, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 96, 120, 168, 216, 264, 336, 504, 672 hours post-dose (Part B)
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-∞) of LY2599666 Part A
Description
Area Under the Concentration versus Time Curve of zero to infinity (0 to ∞) after a single dose of LY2599666 administered subcutaneously.
Time Frame
Day 1: Pre-dose and 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 504, 672 hours post-dose (Part A)
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 168 Hours (AUC 0-168) of LY2599666 Part B
Description
Area Under the Concentration time versus curve from 0-168 hours after weekly dose of LY2599666 administered subcutaneously.
Time Frame
Day 85: Pre-dose, 2, 4, 8, 12, 24, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 96, 120, 168 hours post-dose (Part B)
Title
Plasma Amyloid Beta1-40 (Aβ1-40 ) Concentration Part A
Description
Concentration of plasma amyloid beta 1-40 in healthy participants after single dose of LY2599666 administered subcutaneously.
Time Frame
Day 1: Pre-dose and 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 504, 672 hours post-dose (Part A)
Title
Plasma Amyloid Beta (Aβ1-40 and Aβ1-42) Concentration Part B
Description
Concentration of plasma amyloid beta 1-40 and 1-42, in participants with Mild Cognitive Impairment (MCI) or Alzheimer Disease, after multiple doses of LY2599666 administered subcutaneously.
Time Frame
Day 85: Pre-dose, 2, 4, 8, 12, 24, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 96, 120, 168, 216, 264, 336, 504, 672 hours post-dose (Part B)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Participants Part A:
Overtly healthy males or females as determined by medical history and physical examination
Have a body mass index (BMI) between 18.0 and 32.0 kilograms per meter squared (kg/m²), inclusive
Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part B and C]:
Participants are at least 50 years old at screening
Present with Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild-to-moderate AD
Have a caregiver/study informant who provides 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:
All Participants
Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have known allergies to LY2599666, solanezumab, or any related compounds or components of the formulations, or have a history of significant atopy
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have an abnormal blood pressure as determined by the investigator
Have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisone
Require treatment with other monoclonal antibodies
Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part B and C]
Have medical or surgical conditions in which lumbar puncture and or/catheter insertion is contraindicated
Have any contraindication for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI
Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part C]
Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen post treatment
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
Parexel Early Phase Unit at Glendale
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
CRI Lifetree
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
PRA Health Sciences
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
City
Kobe
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
City
Shinjuku-Ku
ZIP/Postal Code
169-0073
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/3BploURamQkS2qACASCoSc#?postal=
Description
A Study of LY2599666 in Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD)
Learn more about this trial
A Study of LY2599666 in Healthy Participants and Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD)
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