A Study of LY3537021 in Healthy Participants

NCT05444569 | Completed Phase 1

• 2 other identifiers: 18449J2R-MC-YAAC
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

LY3537021 + Liraglutide (Part A)

EXPERIMENTAL

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

Drug: LY3537021; Drug: Liraglutide

Liraglutide + Placebo (Part A)

EXPERIMENTAL

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

Drug: Liraglutide; Drug: Placebo

LY3537021 + Liraglutide & Placebo + Liraglutide (Part B)

EXPERIMENTAL

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; Drug: Liraglutide; Drug: Placebo

Placebo + Liraglutide & LY3537021 + Liraglutide Part B)

EXPERIMENTAL

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; Drug: Liraglutide; Drug: Placebo

Interventions

LY3537021 DRUG

Administered SC.

LY3537021 + Liraglutide & Placebo + Liraglutide (Part B); LY3537021 + Liraglutide (Part A); Placebo + Liraglutide & LY3537021 + Liraglutide Part B)

Liraglutide DRUG

Administered SC.

LY3537021 + Liraglutide & Placebo + Liraglutide (Part B); LY3537021 + Liraglutide (Part A); Liraglutide + Placebo (Part A); Placebo + Liraglutide & LY3537021 + Liraglutide Part B)

Placebo DRUG

Administered SC.

LY3537021 + Liraglutide & Placebo + Liraglutide (Part B); Liraglutide + Placebo (Part A); Placebo + Liraglutide & LY3537021 + Liraglutide Part B)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

MeSH Terms

Interventions

Liraglutide

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 6, 2022
• Study Start: August 8, 2022
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)