A Study of LY3537031 in Healthy Participants | NCT04648865

Studies
A Study of LY3537031 in Healthy Participants

NCT04648865

Sponsor

Eli Lilly and Company

Status

Completed

Last Update Posted

Jun 21, 2021Actual

Enrollment

40Actual

Phase

Phase 1

Conditions

Healthy

Interventions

LY3537031
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
J2S-MC-GZMA	Other Identifier	Eli Lilly and Company

Status Module

Record Verification Date

Jun 15, 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2020Actual

Primary Completion Date

Jun 4, 2021Actual

Completion Date

Jun 4, 2021Actual

First Submitted Date

Nov 24, 2020

First Submission Date that Met QC Criteria

Nov 24, 2020

First Posted Date

Dec 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2021

Last Update Posted Date

Jun 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3537031 in healthy participants. The blood tests will be performed to check how much LY3537031 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3537031. Each participant will receive a single dose of LY3537031 or placebo. The study will last up to approximately 71 days for each participant, including screening.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LY3537031	Experimental	LY3537031 administered subcutaneously (SC).	Drug: LY3537031
Placebo	Placebo Comparator	Placebo administered SC.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LY3537031	Drug	Administered SC.	LY3537031
Placebo

Outcomes Module

Primary Outcomes

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 through final follow-up at approximately Day 43

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537031	PK: AUC of LY3537031	Baseline through final follow-up at approximately Day 43
PK: Maximum Concentration (Cmax) of LY3537031

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Are male or female not of childbearing potential
Have a body mass index (BMI) between 19 and 35 kilograms per square meter (kg/m²) and a body weight ≥ 54 kilograms (kg)
Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
Have veins suitable for blood sampling

Exclusion Criteria:

Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Have a diagnosis or history of cancer or malignant disease within 5 years
Have been treated with prescription and over-the-counter medications that promote weight loss within 3 months prior to screening
Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive
Have undergone any form of bariatric surgery
Have previously completed or withdrawn from this study
Are currently participating in or completed a clinical trial within the last 3 months
Regularly use known drugs of abuse or with positive drug results
Smoke >10 cigarettes per day or the equivalent, or are unable or unwilling to refrain from nicotine during CRU admission

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Hospital Tokyo		Shinjuku-ku	Tokyo	162-0053	Japan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided