Ametris Expands Obesity Drug Development Initiative with Major Pharma Partners

Ametris, formerly known as ActiGraph, has established its second Digital Endpoint Collaboration Outcome Development (DECODE) working group to advance drug development for obesity treatments. The initiative brings together pharmaceutical giants including Eli Lilly and Company, F. Hoffman LaRoche, and Novo Nordisk in a collaborative effort to enhance clinical programs through sophisticated patient monitoring and evidence generation.

The DECODE Obesity working group addresses a critical need for precise, impartial evaluations of physical activity, function, and sleep in remote patient environments. This approach aligns with evolving regulatory expectations for digital health technologies in clinical investigations, particularly the FDA's guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. The collaboration emphasizes evidence generation and regulatory engagement as core pillars for strengthening obesity clinical programs with mature assessments of patient-centered outcomes.

Ametris brings its comprehensive platform that integrates advanced wearable technology, expert scientific consultation, and regulatory-aligned analytics to support every phase of clinical trials. The company specializes in transforming complex, real-world patient data into actionable evidence for life sciences organizations. The emphasis on fit-for-purpose solutions reflects the industry's recognition that rigorous verification and analytical validation are essential for generating reliable clinical endpoints.

"Embarking on a project where we can investigate how to generate patient-centered novel endpoints is a great opportunity," said Mads Frederik Rasmussen, senior vice president of regulatory, quality and clinical reporting at Novo Nordisk. Rasmussen added that Novo Nordisk looks forward to joining forces in this industry collaboration and setting direction for how to secure future-fit label claims through real-time data acquisition. "It is important that we get this right, so that we can collect more accurate data to benefit patients across the globe," said Rasmussen.

This initiative builds upon Ametris' expanding portfolio of digital health collaborations. The company previously launched the DECODE Nocturnal Scratch working group in 2023, focused on developing novel digital measures for dermatological conditions such as atopic dermatitis and psoriasis. Recent strategic partnerships with Luca Healthcare and ZEPHYRx have further expanded Ametris' capabilities in decentralized clinical trials and respiratory function monitoring, positioning the company as a comprehensive provider of digital endpoint solutions across therapeutic areas.

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