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

NCT03720548 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17019J1G-MC-LAKA
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 11

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.

Conditions

Alzheimer Disease

Outcome Measures

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

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  Baseline up to Day 562

Secondary Outcomes (5)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3372993 After a Single Dose

  Predose up to Day 85

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

  Predose up to Day 85

• PK: AUC of LY3372993 at Steady State after Multiple Doses

  Week 14 through Week 18

• PK: Cmax of LY3372993 at Steady State After Multiple Doses

  Week 14 through Week 18

• Pharmacodynamics (PD): Change from Baseline in Amyloid Load

  Baseline, Week 28

Study Arms (4)

LY3372993 (Part A)

EXPERIMENTAL

LY3372993 administered intravenously (IV) to healthy participants.

Drug: LY3372993

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered IV to healthy participants.

Drug: Placebo

LY3372993 (Part B)

EXPERIMENTAL

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

Drug: LY3372993

Placebo (Part B)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LY3372993 DRUG

Administered IV.

LY3372993 (Part A); LY3372993 (Part B)

Placebo DRUG

Administered IV.

Placebo (Part A); Placebo (Part B)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (11)

Collaborative Neuroscience Network - CNS

Long Beach, California, 90806, United States

Location

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Location

Avail Clinical Research LLC

DeLand, Florida, 32720, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

BioClinica Inc

Orlando, Florida, 32806, United States

Location

IMIC, Inc.

Palmetto Bay, Florida, 33157, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

BioClinica Inc

The Villages, Florida, 32162, United States

Location

Atlanta Center of Medical Research

Atlanta, Georgia, 30331, United States

Location

Carolina Phase 1 Research (Wake M3)

Raleigh, North Carolina, 27612, United States

Location

PRA Health Sciences

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 25, 2018
• Study Start: November 5, 2018
• Primary Completion: May 14, 2019
• Study Completion: May 14, 2019
• Last Updated: June 5, 2019

Record last verified: 2019-06-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)