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OpenTrials
Completed

NCT Number: NCT05444569

A Study of LY3537021 in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3537021 when administered in combination with glucagon-like peptide (GLP-1) receptor agonist called liraglutide in treatment-naïve healthy participants. The study will include 2 parts. The study will last up to 16 and 22 weeks for part A and B, respectively which includes a screening period of 6 weeks.

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Key information

Conditions

Healthy

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants who are overtly healthy as determined through medical evaluation
  • Participants with body weight at least 55 kilograms (kg) and body mass index (BMI) of 23.0 to 40.0 kilograms per meter squared (kg/m²)
  • Males, or females who are not of childbearing potential.
  • Capable of giving signed informed consent form
  • Have blood pressure of less than 150/90 millimeters of mercury (mm Hg) and pulse rate of less than 100 beats per minute (bpm) (supine)

Exclusion criteria

  • Have a significant history of current disorders capable of significantly altering the absorption, metabolism or elimination of drugs
  • History of malignancy within 5 years prior to screening
  • Have evidence of significant active psychiatric disorder(s)
  • Have undergone any form of bariatric surgery
  • Have an abnormality in the 12-lead electrocardiogram (ECG)
  • Are females who are lactating

Treatment and study plan

LY3537021

Drug

Administered SC.

liraglutide

Drug

Administered SC.

Placebo

Drug

Administered SC.

Primary outcomes

  1. Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline up to Week 22

    A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of LY3537021 When Combined With GLP-1 Receptor Agonist in Healthy Participants

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2022
Registry last updated
Mar 1, 2023

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.

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