A Study of LY3537031 in Healthy Participants

NCT04648865 | Completed Phase 1

• 2 other identifiers: 17756J2S-MC-GZMA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537031

  Baseline through final follow-up at approximately Day 43

• PK: Maximum Concentration (Cmax) of LY3537031

  Baseline through final follow-up at approximately Day 43

Study Arms (2)

LY3537031

EXPERIMENTAL

LY3537031 administered subcutaneously (SC).

Drug: LY3537031

Placebo

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

LY3537031 DRUG

Administered SC.

LY3537031

Placebo DRUG

Administered SC.

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, 162-0053, Japan

Location

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: December 9, 2020
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: June 21, 2021

Record last verified: 2021-06-15

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)