NCT05440136

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3462817 in healthy Japanese and non-Japanese participants. The study will also assess how fast LY3462817 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 12 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2022

Typical duration 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

June 27, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

June 28, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

June 27, 2022

Last Update Submit

March 29, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

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

    Baseline through Week 12

Secondary Outcomes (2)

  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3462817

    Predose on Day 1 through Day 85

  • PK: Maximum Concentration (Cmax) of LY3462817

    Predose on Day 1 through Day 85

Study Arms (4)

LY3462817 - SC

EXPERIMENTAL

LY3462817 administered subcutaneously (SC)

Drug: LY3462817 (SC)

LY3462817 - IV

EXPERIMENTAL

LY3462817 administered intravenously (IV)

Drug: LY3462817 (IV)

Placebo - SC

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo (SC)

Placebo - IV

PLACEBO COMPARATOR

Placebo administered IV

Drug: Placebo (IV)

Interventions

LY3462817 (SC)DRUG

Administered SC.

LY3462817 - SC
Placebo (SC)DRUG

Administered SC.

Placebo - SC
LY3462817 (IV)DRUG

Administered IV.

LY3462817 - IV
Placebo (IV)DRUG

Administered IV.

Placebo - IV

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are overtly healthy as determined by medical evaluation
  • Japanese participants must be first generation Japanese and have a body mass index (BMI) of 18.0 to 30.0 kilograms per square meter (kg/m²) (inclusive), and a body weight of 45 and 85 kg (inclusive)
  • Non-Japanese participants have a BMI of 18.0 to 32.0 kg/m² (inclusive), and a minimum body weight of 45 kg
  • Are males who agree to follow contraception requirements or females not of childbearing potential
  • Have blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study

You may not qualify if:

  • Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
  • Have previously participated or withdrawn from this study
  • Have cancer or a malignant disease in the past 5 years
  • Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
  • Are unwilling to receive study drug administration by injections or through the veins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altasciences Clinical Los Angeles, Inc

Cypress, California, 90630, United States

Location

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

June 27, 2022

First Posted

June 30, 2022

Study Start

June 28, 2022

Primary Completion

March 8, 2023

Study Completion

March 8, 2023

Last Updated

March 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)