A Study of How the Body Absorbs LY3537031

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: LY3537031

• Registration Number: NCT07202871
• Lead Sponsor: Eli Lilly and Company

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 available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-24
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Study Start: 2025-11-01
• Primary Completion: 2026-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3537031 - Part A	LY3537031	LY3537031 administered Subcutaneously (SC) in three different injection sites
LY3537031 - Part B	LY3537031	LY3537031 administered Intravenously (IV)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore