A Study of LY3532226 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3532226; Drug: Placebo

• Registration Number: NCT04923269
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-09
• Study Start: 2021-06-10
• Study First Posted: 2021-06-11
• Primary Completion: 2021-10-28
• Study Completion: 2021-10-28
• Status Verified: 2021-12-15
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3532226	LY3532226	Single ascending doses of LY3532226 administered subcutaneously (SC).
Placebo	Placebo	Placebo administered SC.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226	Day 1 through Day 43	PK: Cmax of LY3532226
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226	Day 1 through Day 43	PK: AUC of LY3532226
PK: Time to Maximum Concentration (Tmax) of LY3532226	Day 1 through Day 43	PK: Tmax of LY3532226

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore