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OpenTrials
Completed

NCT Number: NCT07202871

A Study of How the Body Absorbs LY3537031

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.

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Key information

Conditions

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3537031

Drug

Administered SC

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3537031

    Time frame: Day 1 Predose up to Day 64

    PK: AUC of LY3537031

  2. Pharmacokinetics (PK): Maximum Serum Observed Drug Concentration (Cmax) of LY3537031

    Time frame: Day 1 Predose up to Day 64

    PK: Cmax of LY3537031

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, 2-Part Study to Determine the Effect of Injection Site on the Relative Bioavailability of a Single Subcutaneous Dose of LY3537031 and to Evaluate the Pharmacokinetics of a Single Intravenous Dose of LY3537031 in Healthy Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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