NCT02614131

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Dec 2015

Longer than P75 for phase_1 healthy

Geographic Reach
2 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

September 23, 2019

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

November 23, 2015

Results QC Date

June 28, 2019

Last Update Submit

June 9, 2020

Conditions

HealthyAlzheimer's DiseaseMild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline through 4 weeks (Part A) or 16 weeks (Part B )

Secondary Outcomes (6)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part A

    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)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part B

    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)

  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-∞) of LY2599666 Part A

    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)

  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 168 Hours (AUC 0-168) of LY2599666 Part B

    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)

  • Plasma Amyloid Beta1-40 (Aβ1-40 ) Concentration Part A

    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)

  • +1 more secondary outcomes

Study Arms (6)

LY2599666 (Part A)

EXPERIMENTAL

LY2599666 given subcutaneously (SC) once.

Drug: LY2599666

Placebo (Part A)

PLACEBO COMPARATOR

Placebo matching LY2599666 given SC once.

Drug: Placebo SC

LY2599666 (Part B)

EXPERIMENTAL

LY2599666 given SC once weekly for 12 weeks (13 doses).

Drug: LY2599666

Placebo (Part B)

PLACEBO COMPARATOR

Placebo given SC once weekly for 12 weeks (13 doses).

Drug: Placebo SC

Solanezumab (Part C)

EXPERIMENTAL

Solanezumab given intravenously (IV) once weekly or once every 4 weeks for 12 weeks.

Drug: Solanezumab

Placebo (Part C)

PLACEBO COMPARATOR

Placebo given IV once weekly or once every 4 weeks for 12 weeks.

Drug: Placebo IV

Interventions

LY2599666DRUG

Administered SC

LY2599666 (Part A)LY2599666 (Part B)
SolanezumabDRUG

Administered IV

Also known as: LY2062430
Solanezumab (Part C)
Placebo SCDRUG

Administered SC

Placebo (Part A)Placebo (Part B)
Placebo IVDRUG

Administered IV

Placebo (Part C)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Parexel Early Phase Unit at Glendale

Glendale, California, 91206, United States

Location

CRI Lifetree

Marlton, New Jersey, 08053, United States

Location

PRA Health Sciences

Salt Lake City, Utah, 84106, United States

Location

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.

Kobe, 650-0047, Japan

Location

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.

Shinjuku-Ku, 169-0073, Japan

Location

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Interventions

solanezumab

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Limitations and Caveats

Development of LY2599666 was stopped based on lack of efficacy of another compound directed against the same target. Following the enrollment of seven participants into Part B Cohort 5, enrollment was stopped.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2015

First Posted

November 25, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 17, 2020

Results First Posted

September 23, 2019

Record last verified: 2020-06

Locations

US(3)JP(2)