NCT04258826

Brief Summary

The purpose of this study is to learn more about how LY3154207 affects the brain of healthy participants by using magnetic resonance imaging. The study will last up to about nine weeks for each participant and may include up to four visits to the study center.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2021

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2022

Completed
Last Updated

February 22, 2022

Status Verified

February 15, 2022

Enrollment Period

1 year

First QC Date

February 5, 2020

Last Update Submit

February 21, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Intrinsic Functional Connectivity Among Resting-State Networks of the Brain

    Mean Connectivity and Mean Component Weight Between LY3154207 and Placebo in the Dorsal Attention Network (DAN), Frontoparietal Network (FPN), and Executive Control Network (ECN).

    Day 1, Approximately Day 28

Study Arms (2)

LY3154207

EXPERIMENTAL

LY3154207 administered orally in one of two study periods.

Drug: LY3154207

Placebo

PLACEBO COMPARATOR

Placebo administered orally in one of two study periods.

Drug: Placebo

Interventions

LY3154207DRUG

LY3154207 administered orally.

LY3154207
PlaceboDRUG

Placebo administered orally.

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Overtly healthy males and non-childbearing females, as determined through medical history and physical examination

You may not qualify if:

  • Have known or ongoing psychiatric disorders
  • Have contraindications to magnetic resonance imaging (MRI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60659, United States

Location

MeSH Terms

Interventions

LY3154207

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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 6, 2020

Study Start

January 15, 2021

Primary Completion

January 28, 2022

Study Completion

January 28, 2022

Last Updated

February 22, 2022

Record last verified: 2022-02-15

Data Sharing

IPD Sharing
Will not share

Locations

US(1)