A Study of How the Body Absorbs LY3537031

Lilly

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy

Treatments: Drug: LY3537031

Study type: Interventional

Funder types: Industry

Identifiers

NCT07202871

27394

J2S-MC-GZMN (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

LY3537031 - Part A

Experimental group

Description:

LY3537031 administered Subcutaneously (SC) in three different injection sites

Treatment:

Drug: LY3537031

Drug: LY3537031

LY3537031 - Part B

Experimental group

Description:

LY3537031 administered Intravenously (IV)

Treatment:

Drug: LY3537031

Drug: LY3537031