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

NCT ID: NCT04451408

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-07
• Study Completion Date: 2024-11-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

LY3372993 (Part A)

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

Group Type: EXPERIMENTAL

LY3372993

Intervention Type: DRUG

Administered IV or SC.

LY3372993 (Part B)

LY3372993 administered as single dose IV or SC.

Group Type: EXPERIMENTAL

LY3372993

Intervention Type: DRUG

Administered IV or SC.

Placebo (Part A)

Placebo administered as multiple doses IV or SC.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered IV or SC.

Placebo (Part B)

Placebo administered as single dose IV or SC.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered IV or SC.

Interventions

LY3372993

Administered IV or SC.

Intervention Type: DRUG

Placebo

Administered IV or SC.

Intervention Type: DRUG

Eligibility Criteria

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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal 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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Altasciences Clinical Los Angeles, Inc

Cypress, California, United States

Collaborative Neuroscience Research, LLC

Long Beach, California, United States

Accel Research Sites- Clinical Research Unit

DeLand, Florida, United States

MD Clinical

Hallandale, Florida, United States

IMIC, Inc.

Miami, Florida, United States

Ppd Development

Orlando, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Charter Research

The Villages, Florida, United States

Synexus Clinical Research US, Inc.

The Villages, Florida, United States

Covance Dallas

Dallas, Texas, United States

Oita University Hospital

Yufu, Oita Prefecture, Japan

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, Japan

Countries

United States; Japan

Related Links

https://trials.lillytrialguide.com/en-US/trial/3qQDrJd2dTslGhNmqMga6Q

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

Other Identifiers

J1G-MC-LAKB

Identifier Type: OTHER

Identifier Source: secondary_id

17755

Identifier Type: -

Identifier Source: org_study_id