MedPath

LY-3537031

Generic Name
LY-3537031

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: May 22, 2025

Comprehensive Report on LY-3537031: An Investigational Dual GIPR/GLP-1R Agonist

1. Executive Summary of LY-3537031

LY-3537031 is an investigational synthetic peptide currently under development by Eli Lilly and Company, positioned within the therapeutic area of endocrinology and metabolic diseases, with a primary focus on obesity.[1] The compound functions as a dual agonist for the glucose-dependent insulinotropic polypeptide receptor (GIPR) and the glucagon-like peptide-1 receptor (GLP-1R).[1] This mechanism of action is well-established within Eli Lilly's portfolio, notably with the successful drug tirzepatide. LY-3537031 is administered subcutaneously and is recognized as a New Molecular Entity (NME), a designation that underscores its novelty and potential for market exclusivity upon approval.[2]

The clinical development program for LY-3537031 is in Phase 1. A single ascending dose (SAD) study, NCT04648865, conducted in healthy Japanese volunteers, has been completed.[1] A more extensive multiple ascending dose (MAD) study, NCT06606106, is currently recruiting participants, including overweight and obese individuals, as well as healthy volunteers from diverse ethnic backgrounds, including Japanese and Chinese cohorts.[1] This ongoing trial aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of LY-3537031, including its effects on body weight and gastric emptying. The development of LY-3537031, identified in Eli Lilly's pipeline as "GIP/GLP-1 Coagonist III" [6], signifies a continued strategic investment by the company in leveraging dual incretin agonism to address the significant unmet medical needs in obesity and related metabolic conditions.

2. Introduction to LY-3537031

Background and Rationale for Development in Obesity and Metabolic Diseases

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.