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OpenTrials
Completed

NCT Number: NCT04451408

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Oita University Hospital, Yufu, Oita Prefecture, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3372993

Drug

Administered IV or SC.

Placebo

Drug

Administered IV or SC.

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

    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

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3372993

    Time frame: 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

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

    PK: AUC of LY3372993

  3. Pharmacodynamics (PD): Change from Baseline in Cerebral Amyloid Plaque Level (Part A only)

    Time frame: Baseline and Week 61 (part A)

    PD: Cerebral amyloid plaque level measured using florbetapir positron emission tomography

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3372993 in Participants With Alzheimer's Disease and Healthy Participants

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 30, 2020
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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