A Study of LY3372993 in Participants With Alzheimer's Disease (AD) and Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04451408
Collaborator
(none)
62
Enrollment
11
Locations
4
Arms
38.7
Anticipated Duration (Months)
5.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in participants with AD (part A) and healthy participants who are of first-generation Japanese origin (part B). The study will also investigate how much LY3372993 gets into the bloodstream and will test the effects of LY3372993. Participation could last up to about 61 weeks and may include up to 28 visits to the study center.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3372993 in Participants With Alzheimer's Disease and Healthy Participants
Actual Study Start Date :
Jul 7, 2020
Anticipated Primary Completion Date :
Sep 29, 2023
Anticipated Study Completion Date :
Sep 29, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: LY3372993 (Part A)

LY3372993 administered intravenously (IV).

Drug: LY3372993
Administered IV.

Experimental: LY3372993 (Part B)

LY3372993 administered IV in Japanese Participants.

Drug: LY3372993
Administered IV.

Placebo Comparator: Placebo (Part A)

Placebo administered IV.

Drug: Placebo
Administered IV.

Placebo Comparator: Placebo (Part B)

Placebo administered IV in Japanese Participants.

Drug: Placebo
Administered IV.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [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

Secondary Outcome Measures

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3372993 [Day 1 Predose through Week 61 (part A) and Week 13 (Part B)]

    PK: Cmax of LY3372993

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372993 [Day 1 Predose through Week 61 (part A) and Week 13 (Part B)]

    PK: AUC of LY3372993

  3. Pharmacodynamics (PD): Change from Baseline in Amyloid Load (Part A only) [Baseline and Week 25 (part A)]

    PD: Amyloid load measured using florbetapir F18 positron emission tomography scans

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

(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)

  • 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.

Exclusion Criteria:

(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) scan

  • 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

  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1WCCT GlobalCypressCaliforniaUnited States90630
2Collaborative Neuroscience Research, LLCLong BeachCaliforniaUnited States90806
3Accel Research Sites- Clinical Research UnitDeLandFloridaUnited States32720
4MD ClinicalHallandale BeachFloridaUnited States33009
5Charter ResearchLady LakeFloridaUnited States32159
6BioClinica IncOrlandoFloridaUnited States32806-1041
7IMIC, Inc.Palmetto BayFloridaUnited States33157
8Progressive Medical ResearchPort OrangeFloridaUnited States32127
9BioClinica IncThe VillagesFloridaUnited States32162
10The University of Tokyo HospitalBunkyo-kuTokyoJapan113-8655
11Clinical Research Hospital TokyoShinjuku-kuTokyoJapan162-0053

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04451408
Other Study ID Numbers:
  • 17755
  • J1G-MC-LAKB
First Posted:
Jun 30, 2020
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021