A Study of LY3537021 in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3537021
* Drug: Liraglutide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study has two parts. Part A is parallel model and part B is crossover.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3537021 + Liraglutide (Part A)<br>Liraglutide administered subcutaneously (SC) followed by liraglutide in combination with LY3537021 given SC. | Drug: LY3537021<br>* Administered SC.<br>Drug: Liraglutide<br>* Administered SC.<br>|
| Experimental: Liraglutide + Placebo (Part A)<br>Liraglutide administered SC followed by liraglutide in combination with placebo given SC. | Drug: Liraglutide<br>* Administered SC.<br>Drug: Placebo<br>* Administered SC.<br>|
| Experimental: LY3537021 + Liraglutide & Placebo + Liraglutide (Part B)<br>LY3537021 administered SC followed by liraglutide administered SC in treatment period 1. Placebo administered SC followed by liraglutide administered SC in treatment period 2. | Drug: LY3537021<br>* Administered SC.<br>Drug: Liraglutide<br>* Administered SC.<br>Drug: Placebo<br>* Administered SC.<br>|
| Experimental: Placebo + Liraglutide & LY3537021 + Liraglutide Part B)<br>Placebo administered SC followed by liraglutide administered SC in treatment period 1. LY3537021 administered SC followed by liraglutide administered SC in treatment period 2. | Drug: LY3537021<br>* Administered SC.<br>Drug: Liraglutide<br>* Administered SC.<br>Drug: Placebo<br>* Administered SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |