A Study of LY3537031 in Healthy Participants

Healthy Clinical Trial

Official title:

A Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3537031 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648865
• Other study ID #: 17756
• Secondary ID: J2S-MC-GZMA
• Status: Completed
• Phase: Phase 1
• Start date: December 9, 2020
• Est. completion date: June 4, 2021

Study information

• Verified date: June 15, 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3537031 in healthy participants. The blood tests will be performed to check how much LY3537031 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3537031. Each participant will receive a single dose of LY3537031 or placebo. The study will last up to approximately 71 days for each participant, including screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Are male or female not of childbearing potential

• Have a body mass index (BMI) between 19 and 35 kilograms per square meter (kg/m²) and a body weight = 54 kilograms (kg)

• Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study

• Have veins suitable for blood sampling

Exclusion Criteria:

• 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 a diagnosis or history of cancer or malignant disease within 5 years

• Have been treated with prescription and over-the-counter medications that promote weight loss within 3 months prior to screening

• Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive

• Have undergone any form of bariatric surgery

• Have previously completed or withdrawn from this study

• Are currently participating in or completed a clinical trial within the last 3 months

• Regularly use known drugs of abuse or with positive drug results

• Smoke >10 cigarettes per day or the equivalent, or are unable or unwilling to refrain from nicotine during CRU admission

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3537031
Administered SC.
• Placebo
Administered SC.

Locations

Country	Name	City	State
Japan	Clinical Research Hospital Tokyo	Shinjuku-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

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 (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537031	PK: AUC of LY3537031	Baseline through final follow-up at approximately Day 43
Secondary	PK: Maximum Concentration (Cmax) of LY3537031	PK: Cmax of LY3537031	Baseline through final follow-up at approximately Day 43