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

NCT04451408 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17755J1G-MC-LAKB
• Study Type: interventional
• Target: 139
• Locations: 2 countries
• Sites: 13

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline through Week 61 (part A) and Week 13 (Part B)

Secondary Outcomes (3)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3372993

  Day 1 Predose through Week 61 (part A) and Week 13 (Part B)

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372993

  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)

  Baseline and Week 61 (part A)

Study Arms (4)

LY3372993 (Part A)

EXPERIMENTAL

LY3372993 administered as multiple doses either intravenously (IV) or subcutaneously (SC).

Drug: LY3372993

LY3372993 (Part B)

EXPERIMENTAL

LY3372993 administered as single dose IV or SC.

Drug: LY3372993

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered as multiple doses IV or SC.

Drug: Placebo

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered as single dose IV or SC.

Drug: Placebo

Interventions

LY3372993 DRUG

Administered IV or SC.

LY3372993 (Part A); LY3372993 (Part B)

Placebo DRUG

Administered IV or SC.

Placebo (Part A); Placebo (Part B)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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
• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (13)

Altasciences Clinical Los Angeles, Inc

Cypress, California, 90630, United States

Location

Collaborative Neuroscience Research, LLC

Long Beach, California, 90806, United States

Location

Accel Research Sites- Clinical Research Unit

DeLand, Florida, 32720, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

IMIC, Inc.

Miami, Florida, 33176, United States

Location

Ppd Development

Orlando, Florida, 32806-1041, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Charter Research

The Villages, Florida, 32162, United States

Location

Synexus Clinical Research US, Inc.

The Villages, Florida, 32162, United States

Location

Covance Dallas

Dallas, Texas, 75247, United States

Location

Oita University Hospital

Yufu, Oita Prefecture, 879-5503, Japan

Location

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, 162-0053, Japan

Location

Related Links

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

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: June 30, 2020
• Study Start: July 7, 2020
• Primary Completion: November 18, 2024
• Study Completion: November 18, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10); JP (3)