HealthyPhase 1NCT02614131
A Study of LY2599666 in Healthy Participants and Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD)
A Phase 1 study testing LY2599666 and Solanezumab in people with Healthy and Alzheimer's Disease, run by Eli Lilly and Company at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Alzheimer's Disease, Mild Cognitive Impairment
- What is being tested?
- LY2599666 and Solanezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Dec 2015to Dec 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
Parexel Early Phase Unit at Glendale
Glendale, California, 91206
CRI Lifetree
Marlton, New Jersey, 08053
PRA Health Sciences
Salt Lake City, Utah, 84106
Japan2 sites
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
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
About this study
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
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.
- Conditions
- Healthy, Alzheimer's Disease, Mild Cognitive Impairment
- Being tested
- LY2599666, Solanezumab, Placebo SC, Placebo IV
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2599666Drug
Administered SC
SolanezumabDrug
Also called LY2062430
Administered IV
Placebo SCDrug
Administered SC
Placebo IVDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY2599666 (Part A) | Experimental | LY2599666 given subcutaneously (SC) once. Receives: Drug: LY2599666 |
| Placebo (Part A) | Placebo comparator | Placebo matching LY2599666 given SC once. Receives: Drug: Placebo SC |
| LY2599666 (Part B) | Experimental | LY2599666 given SC once weekly for 12 weeks (13 doses). Receives: Drug: LY2599666 |
| Placebo (Part B) | Placebo comparator | Placebo given SC once weekly for 12 weeks (13 doses). Receives: Drug: Placebo SC |
| Solanezumab (Part C) | Experimental | Solanezumab given intravenously (IV) once weekly or once every 4 weeks for 12 weeks. Receives: Drug: Solanezumab |
| Placebo (Part C) | Placebo comparator | Placebo given IV once weekly or once every 4 weeks for 12 weeks. Receives: Drug: Placebo IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through 4 weeks (Part A) or 16 weeks (Part B )
Secondary outcomes (6)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part A
PK: Cmax of LY2599666 after a single dose administered subcutaneously.
Measured: 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
PK: Cmax of LY2599666 after multiple doses administered subcutaneously.
Measured: 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
Area Under the Concentration versus Time Curve of zero to infinity (0 to ∞) after a single dose of LY2599666 administered subcutaneously.
Measured: 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
Area Under the Concentration time versus curve from 0-168 hours after weekly dose of LY2599666 administered subcutaneously.
Measured: 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
Concentration of plasma amyloid beta 1-40 in healthy participants after single dose of LY2599666 administered subcutaneously.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: New data suggests that insufficient target engagement would be achieved for efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614131
- Sponsor's protocol ID
- 15491
- Other IDs
- I2L-MC-ALCA
- Status last verified
- Jun 2020
- First submitted
- 23 Nov 2015
- Last updated
- 17 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02614131
- Acronym / sponsor ID
- 15491
- Conditions
- Healthy, Alzheimer's Disease, Mild Cognitive Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New data suggests that insufficient target engagement would be achieved for efficacy.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Posted 23 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LY2599666 (Part A) | Experimental | Drug: LY2599666LY2599666 given subcutaneously (SC) once. |
| Placebo (Part A) | Placebo comparator | Drug: Placebo SCPlacebo matching LY2599666 given SC once. |
| LY2599666 (Part B) | Experimental | Drug: LY2599666LY2599666 given SC once weekly for 12 weeks (13 doses). |
| Placebo (Part B) | Placebo comparator | Drug: Placebo SCPlacebo given SC once weekly for 12 weeks (13 doses). |
| Solanezumab (Part C) | Experimental | Drug: SolanezumabSolanezumab given intravenously (IV) once weekly or once every 4 weeks for 12 weeks. |
| Placebo (Part C) | Placebo comparator | Drug: Placebo IVPlacebo given IV once weekly or once every 4 weeks for 12 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2599666Administered SC | Drug | LY2599666 (Part A), LY2599666 (Part B) |
| SolanezumabAlso: LY2062430Administered IV | Drug | Solanezumab (Part C) |
| Placebo SCAdministered SC | Drug | Placebo (Part A), Placebo (Part B) |
| Placebo IVAdministered IV | Drug | Placebo (Part C) |
Primary outcome
Number of Participants With One or More Serious Adverse Event (SAE) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline through 4 weeks (Part A) or 16 weeks (Part B )
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.
6 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part A
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)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part B
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)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-∞) of LY2599666 Part A
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)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 168 Hours (AUC 0-168) of LY2599666 Part B
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)
Plasma Amyloid Beta1-40 (Aβ1-40 ) Concentration Part A
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)
Plasma Amyloid Beta (Aβ1-40 and Aβ1-42) Concentration Part B
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Study of LY2599666 in Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY2599666 and Solanezumab in people with Healthy and Alzheimer's Disease, run by Eli Lilly and Company at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With One or More Serious Adverse Event (SAE) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through 4 weeks (Part A) or 16 weeks (Part B )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.