Obesity and beyond: Embracing multi-indication potential during clinical development

The last few years have seen the accelerating emergence of multi-indication therapeutics, such as the incretin agonists semaglutide and tirzepatide, which demonstrate significant efficacy in treating diabetes, obesity and their comorbidities. What started as a series of unexpected clinical discoveries has developed into intentional strategies of multi-indication drug development. This trend is largely driven by an increasing understanding of the molecular, hormonal and other interconnected mechanisms and risk factors that intersect with the condition of obesity.

Building on our previous whitepaper reviewing obesity as a multi-faceted risk factor, this paper delves into the reasons behind, and the methods for, multi-indication study design and label expansion for therapies targeting obesity and its comorbidities. Drawing from a recent ICON survey of 155 sponsors and developers whose research focus includes cardiometabolic-related indications, it covers a wide range of clinical development strategies for molecules with broad clinical and commercial potential.

This whitepaper includes:

• Learnings from recent success in multi-indication development of therapies addressing obesity and its comorbidities
• Insights on adoption of multi-indication development strategies in obesity and related comorbid diseases among today’s developers
• Review of the various multi-indication development and launch strategies available to sponsors
• Specific guidance on multi-indication clinical trial design, including implementation of master protocols, inclusion criteria, endpoint selection, control group design and real-world evidence generation