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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03841630
Recruitment Status : Completed
First Posted : February 15, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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
Healthy Drug: LY3437943 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : March 13, 2019
Actual Primary Completion Date : July 25, 2019
Actual Study Completion Date : July 25, 2019
Arms and Interventions
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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
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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 [ Time Frame: 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 [ Time Frame: Baseline through final follow-up at approximately Day 43 ]
    Pharmacokinetics: AUC(0-inf) of LY3437943

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

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


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841630


Locations
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Singapore
Lilly Centre for Clinical Pharmacology
Singapore, Singapore, 138623
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03841630    
Other Study ID Numbers: 17136
J1I-MC-GZBA ( Other Identifier: Eli Lilly and Company )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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