Ametris (formerly ActiGraph), a global digital health solutions provider transforming real-world patient data into validated clinical evidence, announced the launch of Digital Endpoint Collaboration to accelerate Outcome DEvelopment (DECODE) in Obesity. This cross-industry collaboration between pharmaceutical companies and Ametris will focus on evidence generation and regulatory engagement to enhance clinical programs in obesity with mature assessments of physical activity and function. Initial DECODE Obesity working group members include Eli Lilly and Company, F. Hoffmann La Roche, and Novo Nordisk.

The DECODE Obesity working group’s primary goal is to address the need for accurate, objective assessments of physical activity, function, and sleep in a remote patient environment. Research and development of novel obesity treatments has grown significantly, and accounting for treatment benefit in addition to weight loss has become increasingly important. Continuous and real-life measures of patient mobility and function with wearable digital health technology can provide a low burden solution to measure important covariates and additional clinically meaningful outcome measures to assess efficacy of new treatments.

Aligned with the FDA guidance entitled, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,” a fit-for-purpose solution necessitates rigorous verification and analytical validation. The DECODE Obesity working group is uniting multiple pharmaceutical members to accomplish this research collaboratively.  

“Embarking on a project where we can investigate how to generate patient-centered novel endpoints is a great opportunity. We look forward to joining forces in this industry collaboration, 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 Mads Frederik Rasmussen, Senior Vice President of Regulatory, Quality and Clinical Reporting at Novo Nordisk.

This is the second DECODE initiative led by Ametris, with the first DECODE Nocturnal Scratch working group focused on developing a novel, fit-for-purpose digital measure to support patient-focused drug programs for dermatological conditions such as atopic dermatitis (AD) and psoriasis. This pre-competitive, collaborative evidence-generation framework is a key pillar in Ametris’ strategy to advance the use of digital health technology in areas of high unmet measurement need through rigorous validation, verification, and regulatory engagement.

The DECODE Obesity working group is currently accepting additional collaborators. For more information, please visit the DECODE Obesity webpage.

About Ametris

Founded in 2004, Ametris (formerly ActiGraph) is a global digital health solutions provider transforming real-world patient data into validated clinical evidence. Our end-to-end platform combines advanced wearables, regulatory-aligned analytics, and expert scientific support to simplify every phase of a clinical trial—from study design to submission. Backed by two decades of experience and a collaborative approach, Ametris empowers research teams to run smarter trials, reduce patient burden, and accelerate therapeutic innovation.