PENASCOLA, FL, September 2, 2025 – 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 pharmaceutical members to accomplish this research collaboratively.
“With the patient at the center, Novo Nordisk has pioneered research and development into obesity for the past 30 years. From experience, we know that there is a need for generating patient-centered novel endpoints, and we look forward to this industry collaboration. It is important that we get this right, so we can collect more accurate data, benefitting patients around the world,” said Mads Frederik Rasmussen, Senior Vice President of Regulatory, Quality and Clinical Reporting at Novo Nordisk.
“Lilly is excited to collaborate on an industry-leading digital sensor-based science that will help expedite bringing innovative treatments to patients. We are committed to advancing the development of novel algorithms and related endpoints to assess meaningful aspects of health that matter to patients” said Rich Carter, Vice President of Digital Office and Global Services at Eli Lilly and Company.
This is the second DECODE focus area 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.
Media Contact
Genevieve Baley
Genevieve.baley@ametris.com
