Alzheimer DiseasePhase 1NCT03720548
A Study of LY3372993 in Healthy Participants and Participants With Alzheimer's Disease (AD)
A Phase 1 study testing LY3372993 in people with Alzheimer Disease, run by Eli Lilly and Company at 11 sites in United States.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in healthy participants and participants with AD. The study will also investigate how much LY3372993 gets into the bloodstream and test the effects of LY3372993 in participants with AD. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- LY3372993
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 11 sitesUnited States
- Study dates
- 5 Nov 2018to 14 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A:
- Overtly healthy males or females as determined by medical history and physical examination
- Are between 18 to 45 years old, inclusive
- Male participants agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product
- Female participants not of child-bearing potential
- Have a body mass index of 18.0 to 32 kilograms per square meter (kg/m²) inclusive
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- Part B:
- Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild-to-moderate AD
- Positive florbetapir scan
- Men or nonfertile women, at least 55 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year
- Have up to 2 study partners who can provide health information related to the study about the participant. Study partner(s) will provide a separate written informed consent to participate
Who cannot join
- Have significant abnormalities in brain magnetic resonance imaging (MRI); or have contraindications for MRI
- Have significant allergic reactions to LY3372993, or related compounds, or have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
- Have clinically significant neurological or psychological illness, or other illnesses that could affect the study results
- Part A:
- Have family history of early onset Alzheimer's Disease (AD)
- Have impaired cognitive function
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- Part B:
- History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy
- Previously dosed in any other study investigating active immunization against amyloid beta (Aβ)
- Previously dosed in any other study investigating passive immunization against Aβ within the last 6 months
- Have current serious or unstable illnesses
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Atlanta Center of Medical Research
Atlanta, Georgia, 30331
Covance Clinical Research Inc
Daytona Beach, Florida, 32117
Avail Clinical Research LLC
DeLand, Florida, 32720
MD Clinical
Hallandale, Florida, 33009
Collaborative Neuroscience Network - CNS
Long Beach, California, 90806
BioClinica Inc
Orlando, Florida, 32806
IMIC, Inc.
Palmetto Bay, Florida, 33157
Progressive Medical Research
Port Orange, Florida, 32127
Carolina Phase 1 Research (Wake M3)
Raleigh, North Carolina, 27612
PRA Health Sciences
Salt Lake City, Utah, 84124
BioClinica Inc
The Villages, Florida, 32162
About this study
Official title: A Single-Dose and Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3372993 in Healthy Subjects and Patients With Alzheimer's Disease
The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in healthy participants and participants with AD. The study will also investigate how much LY3372993 gets into the bloodstream and test the effects of LY3372993 in participants with AD.
The study has two parts:
- Part A - Healthy participants will receive LY3372993 or placebo. Part A will last up to 17 weeks;
- Part B - Participants with AD will receive LY3372993 or placebo. Part B will last about 317 days.
Read the detailed description
In April, 2019, Eli Lilly and Company made a business decision to terminate Part B. No participants were enrolled.
- Conditions
- Alzheimer Disease
- Being tested
- LY3372993, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3372993Drug
Administered IV.
PlaceboDrug
Administered IV.
| Study group | Role | What they receive |
|---|---|---|
| LY3372993 (Part A) | Experimental | LY3372993 administered intravenously (IV) to healthy participants. Receives: Drug: LY3372993 |
| Placebo (Part A) | Placebo comparator | Placebo administered IV to healthy participants. Receives: Drug: Placebo |
| LY3372993 (Part B) | Experimental | LY3372993 administered IV to participants with AD. Part B was terminated before any participants received treatment. Receives: Drug: LY3372993 |
| Placebo (Part B) | Placebo comparator | Placebo administered IV to participants with AD. Part B was terminated before any participants received treatment. Receives: Drug: Placebo |
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(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
Measured: Baseline up to Day 562
Secondary outcomes (5)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3372993 After a Single Dose
PK: AUC of LY3372993 After a Single Dose
Measured: Predose up to Day 85
PK: Maximum Observed Concentration (Cmax) of LY3372993 After a Single Dose
PK: Cmax of LY3372993 After a Single Dose
Measured: Predose up to Day 85
PK: AUC of LY3372993 at Steady State after Multiple Doses
PK: AUC of LY3372993 at Steady State after Multiple Doses
Measured: Week 14 through Week 18
PK: Cmax of LY3372993 at Steady State After Multiple Doses
PK: Cmax of LY3372993 at Steady State After Multiple Doses
Measured: Week 14 through Week 18
Pharmacodynamics (PD): Change from Baseline in Amyloid Load
Amyloid load measured by florbetapir F18 positron emission tomography (PET) scan
Measured: Baseline, Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start5 Nov 2018
- Primary completion14 May 2019
- Study completion14 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 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
- NCT03720548
- Sponsor's protocol ID
- 17019
- Other IDs
- J1G-MC-LAKA
- Status last verified
- 1 Jun 2019
- First submitted
- 24 Oct 2018
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose and Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3372993 in Healthy Subjects and Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03720548
- Acronym / sponsor ID
- 17019
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
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 LY3372993 in healthy participants and participants with AD. The study will also investigate how much LY3372993 gets into the bloodstream and test the effects of LY3372993 in participants with AD.
The study has two parts:
- Part A - Healthy participants will receive LY3372993 or placebo. Part A will last up to 17 weeks;
- Part B - Participants with AD will receive LY3372993 or placebo. Part B will last about 317 days.
Detailed description
In April, 2019, Eli Lilly and Company made a business decision to terminate Part B. No participants were enrolled.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY3372993 (Part A) | Experimental | Drug: LY3372993LY3372993 administered intravenously (IV) to healthy participants. |
| Placebo (Part A) | Placebo comparator | Drug: PlaceboPlacebo administered IV to healthy participants. |
| LY3372993 (Part B) | Experimental | Drug: LY3372993LY3372993 administered IV to participants with AD. Part B was terminated before any participants received treatment. |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboPlacebo administered IV to participants with AD. Part B was terminated before any participants received treatment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Overtly healthy males or females as determined by medical history and physical examination
- Are between 18 to 45 years old, inclusive
- Male participants agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product
- Female participants not of child-bearing potential
- Have a body mass index of 18.0 to 32 kilograms per square meter (kg/m²) inclusive
Key exclusion criteria (11 listed)
- Have significant abnormalities in brain magnetic resonance imaging (MRI); or have contraindications for MRI
- Have significant allergic reactions to LY3372993, or related compounds, or have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
- Have clinically significant neurological or psychological illness, or other illnesses that could affect the study results
- Have family history of early onset Alzheimer's Disease (AD)
- Have impaired cognitive function
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 |
|---|---|---|
| LY3372993Administered IV. | Drug | LY3372993 (Part A), LY3372993 (Part B) |
| PlaceboAdministered IV. | Drug | Placebo (Part A), Placebo (Part B) |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline up to Day 562
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
5 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3372993 After a Single Dose
Time frame: Predose up to Day 85
PK: Maximum Observed Concentration (Cmax) of LY3372993 After a Single Dose
Time frame: Predose up to Day 85
PK: AUC of LY3372993 at Steady State after Multiple Doses
Time frame: Week 14 through Week 18
PK: Cmax of LY3372993 at Steady State After Multiple Doses
Time frame: Week 14 through Week 18
Pharmacodynamics (PD): Change from Baseline in Amyloid Load
Time frame: Baseline, Week 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Individual participant dataSharing planned: No
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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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3372993 in people with Alzheimer Disease, run by Eli Lilly and Company at 11 sites in United States.
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 11 inclusion and 11 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: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline up to Day 562). 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 5 Jun 2019.