A Study of How the Body Absorbs LY3537031

NCT07202871 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27394J2S-MC-GZMN
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

LY3537031 DRUG

Administered SC

LY3537031 - Part A

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)