A Study of How the Body Absorbs LY3537031

NCT ID: NCT07202871

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-03
• Study Completion Date: 2026-09-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

LY3537031 - Part A

LY3537031 administered Subcutaneously (SC) in three different injection sites

Group Type: EXPERIMENTAL

LY3537031

Intervention Type: DRUG

Administered SC

LY3537031 - Part B

LY3537031 administered Intravenously (IV)

Group Type: EXPERIMENTAL

LY3537031

Intervention Type: DRUG

Administered IV

Interventions

LY3537031

Administered SC

Intervention Type: DRUG

LY3537031

Administered IV

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Lilly Centre for Clinical Pharmacology

Singapore, , Singapore

Countries

Singapore

Other Identifiers

J2S-MC-GZMN

Identifier Type: OTHER

Identifier Source: secondary_id

27394

Identifier Type: -

Identifier Source: org_study_id