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NCT Number: NCT03720548

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

The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in healthy participants and participants with AD. The study will also investigate how much LY3372993 gets into the bloodstream and test the effects of LY3372993 in participants with AD.

The study has two parts:

* Part A - Healthy participants will receive LY3372993 or placebo. Part A will last up to 17 weeks; * Part B - Participants with AD will receive LY3372993 or placebo. Part B will last about 317 days.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Collaborative Neuroscience Network - CNS, Long Beach, California, United States

Loading trial locations.

About this study

In April, 2019, Eli Lilly and Company made a business decision to terminate Part B. No participants were enrolled.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Part A:

  • Overtly healthy males or females as determined by medical history and physical examination
  • Are between 18 to 45 years old, inclusive
  • Male participants agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product
  • Female participants not of child-bearing potential
  • Have a body mass index of 18.0 to 32 kilograms per square meter (kg/m²) inclusive

Part B:

  • Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild-to-moderate AD
  • Positive florbetapir scan
  • Men or nonfertile women, at least 55 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year
  • Have up to 2 study partners who can provide health information related to the study about the participant. Study partner(s) will provide a separate written informed consent to participate

Exclusion criteria

  • Have significant abnormalities in brain magnetic resonance imaging (MRI); or have contraindications for MRI
  • Have significant allergic reactions to LY3372993, or related compounds, or have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
  • Have clinically significant neurological or psychological illness, or other illnesses that could affect the study results

Part A:

  • Have family history of early onset Alzheimer's Disease (AD)
  • Have impaired cognitive function

Part B:

  • History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy
  • Previously dosed in any other study investigating active immunization against amyloid beta (Aβ)
  • Previously dosed in any other study investigating passive immunization against Aβ within the last 6 months
  • Have current serious or unstable illnesses

Treatment and study plan

LY3372993

Drug

Administered IV.

Placebo

Drug

Administered IV.

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 up to Day 562

    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): Area Under the Concentration Versus Time Curve of LY3372993 After a Single Dose

    Time frame: Predose up to Day 85

    PK: AUC of LY3372993 After a Single Dose

  2. PK: Maximum Observed Concentration (Cmax) of LY3372993 After a Single Dose

    Time frame: Predose up to Day 85

    PK: Cmax of LY3372993 After a Single Dose

  3. PK: AUC of LY3372993 at Steady State after Multiple Doses

    Time frame: Week 14 through Week 18

    PK: AUC of LY3372993 at Steady State after Multiple Doses

  4. PK: Cmax of LY3372993 at Steady State After Multiple Doses

    Time frame: Week 14 through Week 18

    PK: Cmax of LY3372993 at Steady State After Multiple Doses

  5. Pharmacodynamics (PD): Change from Baseline in Amyloid Load

    Time frame: Baseline, Week 28

    Amyloid load measured by florbetapir F18 positron emission tomography (PET) scan

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Single-Dose and Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3372993 in Healthy Subjects and Patients With Alzheimer's Disease

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2018
Registry last updated
Jun 5, 2019

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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