A Study of LY3532226 in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT04923269

Collaborator

(none)

Enrollment

Location

Arms

4.6

Actual Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3532226 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jun 10, 2021

Actual Primary Completion Date :

Oct 28, 2021

Actual Study Completion Date :

Oct 28, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: LY3532226

Single ascending doses of LY3532226 administered subcutaneously (SC).

Drug: LY3532226

Administered SC.

Placebo Comparator: Placebo

Placebo administered SC.

Drug: Placebo

Administered SC.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lilly Centre for Clinical Pharmacology	Singapore		Singapore	138623

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT04923269

Other Study ID Numbers:

17834
J2V-MC-GZLA

First Posted:

Jun 11, 2021

Last Update Posted:

Dec 17, 2021

Last Verified:

Dec 15, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 17, 2021