A Study of How the Body Absorbs LY3537031 | NCT07202871

Studies
A Study of How the Body Absorbs LY3537031

NCT07202871

Sponsor

Eli Lilly and Company

Status

Active, not recruiting

Last Update Posted

Jan 16, 2026Actual

Enrollment

46Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

LY3537031
LY3537031

Countries

Singapore

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-GZMN	Other Identifier	Eli Lilly and Company

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 3, 2025Actual

Primary Completion Date

Sep 2026Estimated

Completion Date

Sep 2026Estimated

First Submitted Date

Sep 24, 2025

First Submission Date that Met QC Criteria

Sep 24, 2025

First Posted Date

Oct 2, 2025Actual

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

Jan 15, 2026

Last Update Posted Date

Jan 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main purpose of this study is to find out how much LY3537031 gets into the blood stream and how long it takes the body to get rid of it when it is injected just under the skin in different parts of the body, and when it is injected into a vein, in healthy participants. This study will also look at the safety and tolerability of LY3537031.

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

46Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LY3537031 - Part A	Experimental	LY3537031 administered Subcutaneously (SC) in three different injection sites	Drug: LY3537031
LY3537031 - Part B	Experimental	LY3537031 administered Intravenously (IV)	Drug: LY3537031

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LY3537031	Drug	Administered SC	LY3537031 - Part A
LY3537031

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3537031	PK: AUC of LY3537031	Day 1 Predose up to Day 64
Pharmacokinetics (PK): Maximum Serum Observed Drug Concentration (Cmax) of LY3537031	PK: Cmax of LY3537031	Day 1 Predose up to Day 64

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Are overtly healthy as determined by medical evaluation including medical history and physical examination.
Have a body weight of at least 45 kg.
Have a Body Mass Index (BMI) within the range of 18.5 and 35.0 kg/m², inclusive
Do not have skin aberrations that would preclude administration of the study drug at the planned injection sites.

Exclusion Criteria:

Have significant history or current cardiovascular, respiratory, hepatic, renal, Gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders that, in the opinion of the investigator, are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
Have a history of atopy; that is, severe or multiple allergic manifestations, or clinically significant multiple or severe drug allergies, or hyperesthesia, or severe post treatment hypersensitivity reactions, or have known allergies to LY3537031, Glucagon-Like Peptide-1 (GLP-1) analogs, or related compounds.
Have undergone any form of bariatric surgery.
Have a diagnosis or history of malignant disease within 5 years before screening, with the following (some exceptions are allowed)
Have a history of or current acute or chronic pancreatitis, or elevation in serum lipase or amylase or both greater than 1.5× Upper Limit of Normal (ULN).
Have a history of chronic liver disease, acute or chronic hepatitis, including a history of autoimmune hepatitis, or any evidence for hepatic impairment.
Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided