What's Happening?
Ametris, formerly known as ActiGraph, has initiated a collaboration with pharmaceutical companies to explore the use of digital endpoints in the development of new obesity therapies. The DECODE Obesity project involves major industry players such as Novo Nordisk, Eli Lilly, and Roche. This initiative aims to enhance clinical programs by integrating assessments of physical activity and function through wearable digital health technologies (DHTs). Ametris is inviting other groups researching weight-loss therapies to join the collaboration, focusing on harnessing data from wearable technologies to measure patient mobility and function in clinical research. The project aligns with FDA recommendations on using DHTs for remote data gathering in clinical trials.
Why It's Important?
The collaboration between Ametris and leading pharmaceutical companies represents a significant step in obesity treatment development. By utilizing digital endpoints, the project seeks to generate patient-centered novel endpoints, potentially leading to more accurate data collection and improved treatment efficacy. This approach could revolutionize how obesity therapies are developed, offering more personalized and effective solutions for patients. The involvement of industry giants like Novo Nordisk and Eli Lilly, known for their GLP-1 agonist-based therapies, underscores the project's potential impact on the obesity market. Successful integration of wearable DHTs could enhance regulatory engagement and evidence generation, benefiting patients globally.
What's Next?
The DECODE Obesity project will focus on three key areas: using physical activity, function, and sleep measures as endpoints in clinical trials; incorporating patient voices in development programs; and securing regulatory buy-in from authorities in the US and Europe. The collaboration aims to unite pharmaceutical members to accomplish research collaboratively, with the goal of improving obesity treatment outcomes. As the project progresses, it may lead to new standards in clinical trial design and data collection, influencing future regulatory guidelines and industry practices.
