A Safety Study of LY3437943 Given as a Single Injection in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03841630
Collaborator
(none)
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Study Details

Study Description

Brief Summary

This study is being conducted to determine the side effects related to LY3437943 given as a single injection under the skin to healthy participants. Blood tests will be performed to check how much LY3437943 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3437943 or placebo. The study will last up to approximately 71 days for each participant, including screening.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3437943 in Healthy Subjects
Actual Study Start Date :
Mar 13, 2019
Actual Primary Completion Date :
Jul 25, 2019
Actual Study Completion Date :
Jul 25, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3437943

Escalating doses of LY3437943 administered as an injection under the skin in healthy participants

Drug: LY3437943
Administered subcutaneously (SC)

Placebo Comparator: Placebo

Matching placebo administered as an injection under the skin in healthy participants

Drug: Placebo
Administered SC

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 through final follow-up at approximately Day 43]

    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: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3437943 [Baseline through final follow-up at approximately Day 43]

    Pharmacokinetics: AUC(0-inf) of LY3437943

  2. Pharmacokinetics: Maximum Concentration (Cmax) of LY3437943 [Baseline through final follow-up at approximately Day 43]

    Pharmacokinetics: Cmax of LY3437943

  3. Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY3437943 [Baseline through final follow-up at approximately Day 43]

    Pharmacokinetics: Tmax of LY3437943

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lilly Centre for Clinical Pharmacology Singapore Singapore 138623

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:
NCT03841630
Other Study ID Numbers:
  • 17136
  • J1I-MC-GZBA
First Posted:
Feb 15, 2019
Last Update Posted:
Aug 6, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Aug 6, 2019