A Study of LY3537021 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3537021; Drug: Placebo; Drug: Liraglutide

• Registration Number: NCT05444569
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-30
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-06
• Study Start: 2022-08-08
• Status Verified: 2023-02
• Primary Completion: 2023-02-24
• Study Completion: 2023-02-24
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liraglutide + Placebo (Part A)	Placebo	Liraglutide administered SC followed by liraglutide in combination with placebo given SC.
Placebo + Liraglutide & LY3537021 + Liraglutide Part B)	Placebo	Placebo administered SC followed by liraglutide administered SC in treatment period 1. LY3537021 administered SC followed by liraglutide administered SC in treatment period 2.
LY3537021 + Liraglutide & Placebo + Liraglutide (Part B)	Placebo	LY3537021 administered SC followed by liraglutide administered SC in treatment period 1. Placebo administered SC followed by liraglutide administered SC in treatment period 2.
Placebo + Liraglutide & LY3537021 + Liraglutide Part B)	LY3537021	Placebo administered SC followed by liraglutide administered SC in treatment period 1. LY3537021 administered SC followed by liraglutide administered SC in treatment period 2.
Placebo + Liraglutide & LY3537021 + Liraglutide Part B)	Liraglutide	Placebo administered SC followed by liraglutide administered SC in treatment period 1. LY3537021 administered SC followed by liraglutide administered SC in treatment period 2.
LY3537021 + Liraglutide (Part A)	LY3537021	Liraglutide administered subcutaneously (SC) followed by liraglutide in combination with LY3537021 given SC.
LY3537021 + Liraglutide & Placebo + Liraglutide (Part B)	LY3537021	LY3537021 administered SC followed by liraglutide administered SC in treatment period 1. Placebo administered SC followed by liraglutide administered SC in treatment period 2.
LY3537021 + Liraglutide (Part A)	Liraglutide	Liraglutide administered subcutaneously (SC) followed by liraglutide in combination with LY3537021 given SC.
Liraglutide + Placebo (Part A)	Liraglutide	Liraglutide administered SC followed by liraglutide in combination with placebo given SC.
LY3537021 + Liraglutide & Placebo + Liraglutide (Part B)	Liraglutide	LY3537021 administered SC followed by liraglutide administered SC in treatment period 1. Placebo administered SC followed by liraglutide administered SC in treatment period 2.

Primary Outcome Measures

Name	Time	Method
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	Baseline up to Week 22	A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore