A Study of LY3537021 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Liraglutide; Drug: Placebo; Drug: LY3537021

Study type: Interventional

Funder types: Industry

Identifiers

NCT05444569

J2R-MC-YAAC (Other Identifier)

18449

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 4 patient groups

LY3537021 + Liraglutide (Part A)

Experimental group

Description:

Liraglutide administered subcutaneously (SC) followed by liraglutide in combination with LY3537021 given SC.

Treatment:

Drug: Liraglutide

Drug: LY3537021

Liraglutide + Placebo (Part A)

Experimental group

Description:

Liraglutide administered SC followed by liraglutide in combination with placebo given SC.

Treatment:

Drug: Liraglutide

Drug: Placebo

LY3537021 + Liraglutide & Placebo + Liraglutide (Part B)

Experimental group

Description:

LY3537021 administered SC followed by liraglutide administered SC in treatment period 1. Placebo administered SC followed by liraglutide administered SC in treatment period 2.

Treatment:

Drug: Liraglutide

Drug: LY3537021

Drug: Placebo

Placebo + Liraglutide & LY3537021 + Liraglutide Part B)

Experimental group

Description:

Placebo administered SC followed by liraglutide administered SC in treatment period 1. LY3537021 administered SC followed by liraglutide administered SC in treatment period 2.

Treatment:

Drug: Liraglutide

Drug: LY3537021

Drug: Placebo