A Study of LY3532226 in Healthy Participants

A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3532226 in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in healthy participants. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. This study will last approximately 8 weeks including screening period.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: LY3532226

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 138623
    • Lilly Centre for Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Overtly healthy males or females not of childbearing potential.
• Body mass index (BMI) within the range of 18.5 to 40 kilograms per meter squared (kg/m²), inclusive

Exclusion Criteria:

• Have a significant history of or current CV (e.g., myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the study intervention; or of interfering with the interpretation of data
• Have a history of malignancy within 5 years prior to screening
• Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
• Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2X the upper limit of normal (ULN) or total bilirubin level (TBL) >1.5X ULN
• Have serum triglyceride level ≥5 mmol/L (442.5 mg/dL)
• Have undergone any form of bariatric surgery
• Have received systemic or inhaled glucocorticoid therapy (excluding topical, intraarticular, and intraocular preparations); for more than 14 consecutive days within 4 weeks before screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered SC.	Drug: Placebo; Administered SC.
Experimental: LY3532226; Single ascending doses of LY3532226 administered subcutaneously (SC).	Drug: LY3532226; Administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline up to Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226	PK: Cmax of LY3532226	Day 1 through Day 43
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226	PK: AUC of LY3532226	Day 1 through Day 43
PK: Time to Maximum Concentration (Tmax) of LY3532226	PK: Tmax of LY3532226	Day 1 through Day 43

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): October 28, 2021
• Study Completion (Actual): October 28, 2021

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 15, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 17834; J2V-MC-GZLA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No