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A Study of LY3372993 in Healthy Participants and Participants With Alzheimer's Disease (AD) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT03720548•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Yes

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
+1 more criteria

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
+1 more criteria

Locations (11)

Collaborative Neuroscience Network - CNS

Long Beach, California, United States

Covance Clinical Research Inc

Daytona Beach, Florida, United States

Avail Clinical Research LLC

DeLand, Florida, United States

MD Clinical

Hallandale, Florida, United States

BioClinica Inc

Orlando, Florida, United States

IMIC, Inc.

Palmetto Bay, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

BioClinica Inc

The Villages, Florida, United States

Atlanta Center of Medical Research

Atlanta, Georgia, United States

Carolina Phase 1 Research (Wake M3)

Raleigh, North Carolina, United States

Key Dates

Start Date

November 5, 2018

Primary Completion Date

May 14, 2019

Completion Date

May 14, 2019

Last Updated

June 5, 2019

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

LY3372993

DRUG

Placebo

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 5, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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