Skip to main content
OpenTrials
Completed

NCT Number: NCT04648865

A Study of LY3537031 in Healthy Participants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, 162-0053, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously completed or withdrawn from this study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

Treatment and study plan

LY3537031

Drug

Administered SC.

Placebo

Drug

Administered SC.

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

    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 outcomes

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

    Time frame: Baseline through final follow-up at approximately Day 43

    PK: AUC of LY3537031

  2. PK: Maximum Concentration (Cmax) of LY3537031

    Time frame: Baseline through final follow-up at approximately Day 43

    PK: Cmax of LY3537031

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2020
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.