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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03720548
• Collaborator: (none)
• Enrollment: 36
• Locations: 11
• Arms: 4
• Actual Duration (Months): 6.2
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: LY3372993; Drug: Placebo	Phase 1

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Nov 5, 2018
• Actual Primary Completion Date: May 14, 2019
• Actual Study Completion Date: May 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3372993 (Part A) LY3372993 administered intravenously (IV) to healthy participants.	Drug: LY3372993; Administered IV.
Placebo Comparator: Placebo (Part A) Placebo administered IV to healthy participants.	Drug: Placebo; Administered IV.
Experimental: LY3372993 (Part B) LY3372993 administered IV to participants with AD. Part B was terminated before any participants received treatment.	Drug: LY3372993; Administered IV.
Placebo Comparator: Placebo (Part B) Placebo administered IV to participants with AD. Part B was terminated before any participants received treatment.	Drug: Placebo; Administered IV.

Outcome Measures

Primary Outcome Measures

1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [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 Outcome Measures

1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3372993 After a Single Dose [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 [Predose up to Day 85]

   PK: Cmax of LY3372993 After a Single Dose

3. PK: AUC of LY3372993 at Steady State after Multiple Doses [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 [Week 14 through Week 18]

   PK: Cmax of LY3372993 at Steady State After Multiple Doses

5. Pharmacodynamics (PD): Change from Baseline in Amyloid Load [Baseline, Week 28]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Collaborative Neuroscience Network - CNS	Long Beach	California	United States	90806
2	Covance Clinical Research Inc	Daytona Beach	Florida	United States	32117
3	Avail Clinical Research LLC	DeLand	Florida	United States	32720
4	MD Clinical	Hallandale Beach	Florida	United States	33009
5	BioClinica Inc	Orlando	Florida	United States	32806
6	IMIC, Inc.	Palmetto Bay	Florida	United States	33157
7	Progressive Medical Research	Port Orange	Florida	United States	32127
8	BioClinica Inc	The Villages	Florida	United States	32162
9	Atlanta Center of Medical Research	Atlanta	Georgia	United States	30331
10	Carolina Phase 1 Research (Wake M3)	Raleigh	North Carolina	United States	27612
11	PRA Health Sciences	Salt Lake City	Utah	United States	84124

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT03720548
• Other Study ID Numbers: 17019; J1G-MC-LAKA
• First Posted: Oct 25, 2018
• Last Update Posted: Jun 5, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Jun 5, 2019