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| ID | Type | Description | Link |
|---|---|---|---|
| I2L-MC-ALCA | Other Identifier | Eli Lilly and Company |
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New data suggests that insufficient target engagement would be achieved for efficacy.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2599666 (Part A) | Experimental | LY2599666 given subcutaneously (SC) once. |
|
| Placebo (Part A) | Placebo Comparator | Placebo matching LY2599666 given SC once. |
|
| LY2599666 (Part B) | Experimental | LY2599666 given SC once weekly for 12 weeks (13 doses). |
|
| Placebo (Part B) | Placebo Comparator | Placebo given SC once weekly for 12 weeks (13 doses). |
|
| Solanezumab (Part C) | Experimental | Solanezumab given intravenously (IV) once weekly or once every 4 weeks for 12 weeks. |
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| Placebo (Part C) | Placebo Comparator | Placebo given IV once weekly or once every 4 weeks for 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2599666 | Drug | Administered SC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 ) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part A | PK: Cmax of LY2599666 after a single dose administered subcutaneously. | 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 |
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Inclusion Criteria:
Healthy Participants Part A:
Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part B and C]:
Exclusion Criteria:
All Participants
Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part B and C]
Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part C]
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel Early Phase Unit at Glendale | Glendale | California | 91206 | United States | ||
| CRI Lifetree |
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| Label | URL |
|---|---|
| A Study of LY2599666 in Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) | View source |
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Following the enrollment of 7 participants into Part B Cohort 5, a decision was made to stop the development of LY2599666 based on the lack of efficacy results of another compound directed against the same target. Participants were not enrolled for Part B Cohorts 6 and 7 or Part C Cohorts 8 and 9.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Part A - Healthy Participants) | Placebo matching dose given subcutaneously (SC) once. |
| FG001 | 10 mg LY2599666 (Part A Cohort 1) | 10 mg LY2599666 given SC once. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Solanezumab |
| Drug |
Administered IV |
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| Placebo SC | Drug | Administered SC |
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| Placebo IV | Drug | Administered IV |
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PK: Cmax of LY2599666 after multiple doses administered subcutaneously. |
| 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. | 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. | 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. | 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. | 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) |
| Marlton |
| New Jersey |
| 08053 |
| United States |
| PRA Health Sciences | Salt Lake City | Utah | 84106 | United States |
| 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 |
| 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 |
| FG002 | 25 mg LY2599666 (Part A Cohort 2) | 25 mg LY2599666 given SC once. |
| FG003 | 100 mg LY2599666 (Part A Cohort 3) | 100 mg LY2599666 given SC once. |
| FG004 | 200 mg LY2599666 (Part A Cohort 4) | 200 mg LY2599666 given SC once. |
| FG005 | Placebo (Part B - Cognitively Impaired) | Placebo matching dose given SC. |
| FG006 | 25 mg LY2599666 (Part B Cohort 5) | 25 mg LY2599666 given SC once weekly for 12 weeks (13 doses). |
| Received at Least One Dose of Drug |
|
| COMPLETED |
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| NOT COMPLETED |
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Part A) | Placebo matching dose given subcutaneously (SC) once. |
| BG001 | 10 mg LY2599666 (Part A Cohort 1) | 10 mg LY2599666 given SC once. |
| BG002 | 25 mg LY2599666 (Part A Cohort 2) | 25 mg LY2599666 given SC once. |
| BG003 | 100 mg LY2599666 (Part A Cohort 3) | 100 mg LY2599666 given SC once. |
| BG004 | 200 mg LY2599666 (Part A Cohort 4) | 200 mg LY2599666 given SC once. |
| BG005 | Placebo (Part B) | Placebo matching dose given SC. |
| BG006 | 25 mg LY2599666 (Part B Cohort 5) | 25 mg LY2599666 given SC once weekly for 12 weeks (13 doses). |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | All randomized participants in Part A and Part B. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| ||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| ||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| ||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through 4 weeks (Part A) or 16 weeks (Part B ) |
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| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part A | PK: Cmax of LY2599666 after a single dose administered subcutaneously. | All participants who received at least one dose of study drug in Part A and had evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | 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) |
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| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part B | PK: Cmax of LY2599666 after multiple doses administered subcutaneously. | All participants who received at least one dose of drug in Part B and had evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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) |
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| Secondary | 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. | All participants who received at least one dose of drug in Part A and had evaluable AUC data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*hr/mL) | 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) |
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| Secondary | 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. | All participants who received at least one dose of drug in Part B and had evaluable AUC data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 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) |
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| Secondary | 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. | All participants who received at least one dose of study drug in Part A and had evaluable Aβ1-40 data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms per milliliter (pg/mL) | 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) |
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| Secondary | 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. | All participants who received at least one dose of study drug in Part B and had evaluable Aβ1-40 or Aβ1-42 data. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | 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) |
|
|
Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Part A) | Placebo matching dose given subcutaneously (SC) once. | 0 | 11 | 0 | 11 | 2 | 11 |
| EG001 | 10 mg LY2599666 (Part A Cohort 1) | 10 mg LY2599666 given SC once. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG002 | 25 mg LY2599666 (Part A Cohort 2) | 25 mg LY2599666 given SC once. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG003 | 100 mg LY2599666 (Part A Cohort 3) | 100 mg LY2599666 given SC once. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG004 | 200 mg LY2599666 (Part A Cohort 4) | 200 mg LY2599666 given SC once. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG005 | Placebo (Part B) | Placebo matching dose given SC. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG006 | 25 mg LY2599666 (Part B Cohort 5) | 25 mg LY2599666 given SC once weekly for 12 weeks (13 doses). | 0 | 5 | 1 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA 18.0 | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA 18.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Faecal incontinence | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection site rash | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Puncture site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Vessel puncture site haemorrhage | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 18.0 | Systematic Assessment |
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| Blood urine present | Investigations | MedDRA 18.0 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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| ID | Term |
|---|---|
| C550616 | solanezumab |
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| Part B |
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| Japan |
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| Units | Counts |
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| Units | Counts |
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