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

Healthy Clinical Trial

Official title:

A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3437943 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841630
• Other study ID #: 17136
• Secondary ID: J1I-MC-GZBA
• Status: Completed
• Phase: Phase 1
• Start date: March 13, 2019
• Est. completion date: July 25, 2019

Study information

• Verified date: August 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 25, 2019
• Est. primary completion date: July 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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• Have previously completed or withdrawn from this study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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3437943
Administered subcutaneously (SC)
• Placebo
Administered SC

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 at approximately Day 43
Secondary	Pharmacokinetics: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3437943	Pharmacokinetics: AUC(0-inf) of LY3437943	Baseline through final follow-up at approximately Day 43
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of LY3437943	Pharmacokinetics: Cmax of LY3437943	Baseline through final follow-up at approximately Day 43
Secondary	Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY3437943	Pharmacokinetics: Tmax of LY3437943	Baseline through final follow-up at approximately Day 43