A Study of LY3532226 in Healthy Participants

NCT04923269 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17834J2V-MC-GZLA
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226

  Day 1 through Day 43

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226

  Day 1 through Day 43

• PK: Time to Maximum Concentration (Tmax) of LY3532226

  Day 1 through Day 43

Study Arms (2)

LY3532226

EXPERIMENTAL

Single ascending doses of LY3532226 administered subcutaneously (SC).

Drug: LY3532226

Placebo

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

LY3532226 DRUG

Administered SC.

LY3532226

Placebo DRUG

Administered SC.

Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

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

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 11, 2021
• Study Start: June 10, 2021
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12-15

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)