A Study of LY3537021 in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05444569

Collaborator

(none)

Enrollment

Location

Arms

6.4

Anticipated Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3537021 Drug: Liraglutide Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study has two parts. Part A is parallel model and part B is crossover.The study has two parts. Part A is parallel model and part B is crossover.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Aug 8, 2022

Anticipated Primary Completion Date :

Feb 20, 2023

Anticipated Study Completion Date :

Feb 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3537021 + Liraglutide (Part A) Liraglutide administered subcutaneously (SC) followed by liraglutide in combination with LY3537021 given SC.	Drug: LY3537021 Administered SC. Drug: Liraglutide Administered SC.
Experimental: Liraglutide + Placebo (Part A) Liraglutide administered SC followed by liraglutide in combination with placebo given SC.	Drug: Liraglutide Administered SC. Drug: Placebo Administered SC.
Experimental: LY3537021 + Liraglutide & Placebo + Liraglutide (Part B) 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 Administered SC. Drug: Liraglutide Administered SC. Drug: Placebo Administered SC.
Experimental: Placebo + Liraglutide & LY3537021 + Liraglutide Part B) 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 Administered SC. Drug: Liraglutide Administered SC. Drug: Placebo Administered SC.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lilly Centre for Clinical Pharmacology	Singapore		Singapore	138623

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT05444569

Other Study ID Numbers:

18449
J2R-MC-YAAC

First Posted:

Jul 6, 2022

Last Update Posted:

Aug 19, 2022

Last Verified:

Aug 15, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liraglutide

Study Results

No Results Posted as of Aug 19, 2022