A Study of LY3537031 in Healthy Participants

NCT ID: NCT04648865

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-09
• Study Completion Date: 2021-06-04

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY3537031

LY3537031 administered subcutaneously (SC).

Group Type: EXPERIMENTAL

LY3537031

Intervention Type: DRUG

Administered SC.

Placebo

Placebo administered SC.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC.

Interventions

LY3537031

Administered SC.

Intervention Type: DRUG

Placebo

Administered SC.

Intervention Type: DRUG

Eligibility Criteria

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• Have previously completed or withdrawn from this study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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

J2S-MC-GZMA

Identifier Type: OTHER

Identifier Source: secondary_id

17756

Identifier Type: -

Identifier Source: org_study_id