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

Alzheimer Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03720548
• Other study ID #: 17019
• Secondary ID: J1G-MC-LAKA
• Status: Completed
• Phase: Phase 1
• Start date: November 5, 2018
• Est. completion date: May 14, 2019

Study information

• Verified date: June 1, 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 14, 2019
• Est. primary completion date: May 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 (Aß)

• Previously dosed in any other study investigating passive immunization against Aß within the last 6 months

• Have current serious or unstable illnesses

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• LY3372993
Administered IV.
• Placebo
Administered IV.

Locations

Country	Name	City	State
United States	Atlanta Center of Medical Research	Atlanta	Georgia
United States	Covance Clinical Research Inc	Daytona Beach	Florida
United States	Avail Clinical Research LLC	DeLand	Florida
United States	MD Clinical	Hallandale Beach	Florida
United States	Collaborative Neuroscience Network - CNS	Long Beach	California
United States	BioClinica Inc	Orlando	Florida
United States	IMIC, Inc.	Palmetto Bay	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Carolina Phase 1 Research (Wake M3)	Raleigh	North Carolina
United States	PRA Health Sciences	Salt Lake City	Utah
United States	BioClinica Inc	The Villages	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3372993 After a Single Dose	PK: AUC of LY3372993 After a Single Dose	Predose up to Day 85
Secondary	PK: Maximum Observed Concentration (Cmax) of LY3372993 After a Single Dose	PK: Cmax of LY3372993 After a Single Dose	Predose up to Day 85
Secondary	PK: AUC of LY3372993 at Steady State after Multiple Doses	PK: AUC of LY3372993 at Steady State after Multiple Doses	Week 14 through Week 18
Secondary	PK: Cmax of LY3372993 at Steady State After Multiple Doses	PK: Cmax of LY3372993 at Steady State After Multiple Doses	Week 14 through Week 18
Secondary	Pharmacodynamics (PD): Change from Baseline in Amyloid Load	Amyloid load measured by florbetapir F18 positron emission tomography (PET) scan	Baseline, Week 28