A Study of LY3537021 in Healthy Participants

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05444569
• Other study ID #: 18449
• Secondary ID: J2R-MC-YAAC
• Status: Completed
• Phase: Phase 1
• Start date: August 8, 2022
• Est. completion date: February 24, 2023

Study information

• Verified date: February 2023
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 24, 2023
• Est. primary completion date: February 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3537021
Administered SC.
• Liraglutide
Administered SC.
• Placebo
Administered SC.

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module	Baseline up to Week 22