Alzheimer DiseasePhase 1NCT04451408
A Study of LY3372993 in Participants With Alzheimer's Disease (AD) and Healthy Participants
A Phase 1 study testing LY3372993 in people with Alzheimer Disease and Healthy, run by Eli Lilly and Company at 13 sites in 2 countries.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in participants with AD, non-Japanese, and Japanese healthy participants who are of first-generation Japanese origin. 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, Healthy
- 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
- 139 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 7 Jul 2020to 18 Nov 2024
- 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)
- Gradual and progressive changes in memory function reported by participants or their partners for greater than or equal to (≥) 6 months at screening, and a clinical diagnosis of mild cognitive impairment due to AD, or AD dementia, as determined by the investigator or based upon medical history
- Mini-Mental State Examination score ≥16
- Have clinical laboratory test results within normal reference range or results with acceptable deviations that are judged to be not clinically significant by the investigator
- Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to study visits or be available through telephone at designated times
- (Part B)
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- overtly healthy males or females
- have a body mass index of 18.0 to 32.0 kg/m2, inclusive
- To qualify as a participant of the first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
Who cannot join
- (Part A)
- Have history or presence of uncontrolled asthma, significant autoimmune disease, hereditary angioedema, or known history of common variable immune deficiency
- Contraindication to positron emission tomography (PET)
- Have a history or presence of serious or unstable illnesses including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study, or increase risk for study intervention administration, or result in a participant's life expectancy of less than (<)24 months
- Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
- Have had significant medical history of dizziness, syncope, or vasovagal attacks within the past 3 years
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- Contraindication to magnetic resonance imaging (MRI), including claustrophobia that cannot be managed with low-dose sedatives or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker
- (Part B)
- have a family history of early onset AD (AD diagnosed prior to 65 years of age)
- have used or intend to use over-the-counter or prescription medication including herbal medications within 14 days prior to dosing.
- have a history or presence of significant psychiatric disorders
- have an abnormal blood pressure and/or pulse rate as determined by the investigator, or a pre-existing history of hypertension
- any clinically significant ECG or brain MRI abnormalities
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States10 sites
Altasciences Clinical Los Angeles, Inc
Cypress, California, 90630
Covance Dallas
Dallas, Texas, 75247
Accel Research Sites- Clinical Research Unit
DeLand, Florida, 32720
MD Clinical
Hallandale, Florida, 33009
Collaborative Neuroscience Research, LLC
Long Beach, California, 90806
IMIC, Inc.
Miami, Florida, 33176
Ppd Development
Orlando, Florida, 32806-1041
Progressive Medical Research
Port Orange, Florida, 32127
Charter Research
The Villages, Florida, 32162
Synexus Clinical Research US, Inc.
The Villages, Florida, 32162
Japan3 sites
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8655
Clinical Research Hospital Tokyo
Shinjuku-ku, Tokyo, 162-0053
Oita University Hospital
Yufu, Oita Prefecture, 879-5503
About this study
Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3372993 in Participants With Alzheimer's Disease and Healthy Participants
The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in participants with AD, non-Japanese, and Japanese healthy participants who are of first-generation Japanese origin. The study will also investigate how much LY3372993 gets into the bloodstream and will test the effects of LY3372993. The study will be conducted in two parts. The part A includes participants with AD and part B includes healthy participants. Participation could last up to about 61 weeks and may include up to 31 visits to the study center.
- Conditions
- Alzheimer Disease, Healthy
- 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 or SC.
PlaceboDrug
Administered IV or SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3372993 (Part A) | Experimental | LY3372993 administered as multiple doses either intravenously (IV) or subcutaneously (SC). Receives: Drug: LY3372993 |
| LY3372993 (Part B) | Experimental | LY3372993 administered as single dose IV or SC. Receives: Drug: LY3372993 |
| Placebo (Part A) | Placebo comparator | Placebo administered as multiple doses IV or SC. Receives: Drug: Placebo |
| Placebo (Part B) | Placebo comparator | Placebo administered as single dose IV or SC. 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 through Week 61 (part A) and Week 13 (Part B)
Secondary outcomes (3)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3372993
PK: Cmax of LY3372993
Measured: Day 1 Predose through Week 61 (part A) and Week 13 (Part B)
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372993
PK: AUC of LY3372993
Measured: Day 1 Predose through Week 61 (part A) and Week 13 (Part B)
Pharmacodynamics (PD): Change from Baseline in Cerebral Amyloid Plaque Level (Part A only)
PD: Cerebral amyloid plaque level measured using florbetapir positron emission tomography
Measured: Baseline and Week 61 (part A)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start7 Jul 2020
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 139 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
- NCT04451408
- Sponsor's protocol ID
- 17755
- Other IDs
- J1G-MC-LAKB
- Status last verified
- Mar 2025
- First submitted
- 26 Jun 2020
- Last updated
- 28 Mar 2025
- 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 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3372993 in Participants With Alzheimer's Disease and Healthy Participants
- ClinicalTrials.gov ID
- NCT04451408
- Acronym / sponsor ID
- 17755
- Conditions
- Alzheimer Disease, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 30 Jun 2020 (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 participants with AD, non-Japanese, and Japanese healthy participants who are of first-generation Japanese origin. The study will also investigate how much LY3372993 gets into the bloodstream and will test the effects of LY3372993. The study will be conducted in two parts. The part A includes participants with AD and part B includes healthy participants. Participation could last up to about 61 weeks and may include up to 31 visits to the study center.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY3372993 (Part A) | Experimental | Drug: LY3372993LY3372993 administered as multiple doses either intravenously (IV) or subcutaneously (SC). |
| LY3372993 (Part B) | Experimental | Drug: LY3372993LY3372993 administered as single dose IV or SC. |
| Placebo (Part A) | Placebo comparator | Drug: PlaceboPlacebo administered as multiple doses IV or SC. |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboPlacebo administered as single dose IV or SC. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- (Part A)
- Gradual and progressive changes in memory function reported by participants or their partners for greater than or equal to (≥) 6 months at screening, and a clinical diagnosis of mild cognitive impairment due to AD, or AD dementia, as determined by the investigator or based upon medical history
- Mini-Mental State Examination score ≥16
- Have clinical laboratory test results within normal reference range or results with acceptable deviations that are judged to be not clinically significant by the investigator
- Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to study visits or be available through telephone at designated times
Key exclusion criteria (13 listed)
- (Part A)
- Have history or presence of uncontrolled asthma, significant autoimmune disease, hereditary angioedema, or known history of common variable immune deficiency
- Contraindication to positron emission tomography (PET)
- Have a history or presence of serious or unstable illnesses including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study, or increase risk for study intervention administration, or result in a participant's life expectancy of less than (<)24 months
- Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
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 or SC. | Drug | LY3372993 (Part A), LY3372993 (Part B) |
| PlaceboAdministered IV or SC. | 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 through Week 61 (part A) and Week 13 (Part B)
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
3 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3372993
Time frame: Day 1 Predose through Week 61 (part A) and Week 13 (Part B)
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372993
Time frame: Day 1 Predose through Week 61 (part A) and Week 13 (Part B)
Pharmacodynamics (PD): Change from Baseline in Cerebral Amyloid Plaque Level (Part A only)
Time frame: Baseline and Week 61 (part A)
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 28 Mar 2025.
- A Study of LY3372993 in Participants With Alzheimer's Disease (AD)Link provided by the sponsor.
- 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
13 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 LY3372993 in people with Alzheimer Disease and Healthy, run by Eli Lilly and Company at 13 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 13 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
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 through Week 61 (part A) and Week 13 (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 28 Mar 2025.