A Safety Study of LY3493269 Given as a Single Injection in Healthy Participants

NCT04178733 | Completed Phase 1 Results

• 2 other identifiers: 17452J1X-MC-GZHA
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to determine the side effects related to LY3493269 given as a single injection to healthy participants. Blood tests will be performed to check how much LY3493269 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3493269 or placebo. The study will last up to approximately 71 days for each participant, including screening.

Conditions

Healthy

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 through final follow-up (Up To Day 43)

Secondary Outcomes (3)

• Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269

  Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 and early termination

• PK: Maximum Concentration (Cmax) of LY3493269

  Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination

• PK: Time to Maximum Concentration (Tmax) of LY3493269

  Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination

Study Arms (5)

Placebo - SC

PLACEBO COMPARATOR

Participants received Placebo subcutaneously (SC).

Drug: Placebo - SC

0.5 mg LY3493269 IV

EXPERIMENTAL

Participants received 0.5 mg LY3493269 intravenously (IV).

Drug: LY3493269 - IV

0.15 mg LY3493269 SC

EXPERIMENTAL

Participants received 0.15 mg LY3493269 SC.

Drug: LY3493269 - SC

0.5 mg LY3493269 SC

EXPERIMENTAL

Participants received 0.5 mg LY3493269 SC.

Drug: LY3493269 - SC

1.5 mg LY3493269 SC

EXPERIMENTAL

Participants received 1.5 mg LY3493269 SC.

Drug: LY3493269 - SC

Interventions

LY3493269 - SC DRUG

Administered SC

0.15 mg LY3493269 SC; 0.5 mg LY3493269 SC; 1.5 mg LY3493269 SC

Placebo - SC DRUG

Administered SC

Placebo - SC

LY3493269 - IV DRUG

Administered IV

0.5 mg LY3493269 IV

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overtly healthy male or a female who cannot get pregnant
• Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m²), inclusive, at screening
• Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
• Have veins suitable for ease of blood sampling

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 completed or withdrawn from this study
• Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study
• 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
• Have been treated with weight loss medications within 3 months of screening

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

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

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: GT60
• Restrictive Agreement: Yes

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: November 25, 2019
• First Posted: November 26, 2019
• Study Start: January 10, 2020
• Primary Completion: May 11, 2020
• Study Completion: May 11, 2020
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)