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

NCT ID: NCT03720548

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2019-05-14

Brief 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.

Conditions

Alzheimer Disease

Study Design

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

Study Groups

LY3372993 (Part A)

LY3372993 administered intravenously (IV) to healthy participants.

Group Type: EXPERIMENTAL

LY3372993

Intervention Type: DRUG

Administered IV.

Placebo (Part A)

Placebo administered IV to healthy participants.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered IV.

LY3372993 (Part B)

LY3372993 administered IV to participants with AD. Part B was terminated before any participants received treatment.

Group Type: EXPERIMENTAL

LY3372993

Intervention Type: DRUG

Administered IV.

Placebo (Part B)

Placebo administered IV to participants with AD. Part B was terminated before any participants received treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered IV.

Interventions

LY3372993

Administered IV.

Intervention Type: DRUG

Placebo

Administered IV.

Intervention Type: DRUG

Eligibility Criteria

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

• 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

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

PRA Health Sciences

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

J1G-MC-LAKA

Identifier Type: OTHER

Identifier Source: secondary_id

17019

Identifier Type: -

Identifier Source: org_study_id