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Ametris (formerly ActiGraph) has launched its second Digital Endpoint Collaboration Outcome Development (DECODE) working group for the purpose of enhancing drug development for obesity.
The company is collaborating with pharmaceutical companies, including Eli Lilly and Company, F. Hoffman LaRoche and Novo Nordisk.
The collaboration aims to focus on evidence generation and regulatory engagement to strengthen clinical programs in obesity with mature assessments of physical activity and function, according to Ametris.
The DECODE Obesity working group's primary objective is to address the need for precise, impartial evaluations of physical activity, function and sleep in a remote patient environment.
Ametris partners with life sciences organizations to transform complex, real-world patient data into evidence. The company's end-to-end platform integrates advanced wearable technology, expert scientific consultation and regulatory-aligned analytics to support every phase of a clinical trial.
Noting that a fit-for-purpose solution necessitates rigorous verification and analytical validation, the company said the new initiative is in accordance with the FDA guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.
"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, in a statement.
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.
THE LARGER TREND
In August, ActiGraph and Luca Healthcare announced a strategic partnership aimed at enhancing the adoption and deployment of digital health tools in clinical trials, especially within the U.S. and Chinese markets.
Under the partnership, Luca Healthcare will help expand Ametris' existing business in China and Asia by integrating Ametris' wearable technologies with pharmaceutical partners, enabling Ametris to offer a full range of decentralized clinical trial products and services for the Chinese and Asian markets.
At the same time, Ametris will support Luca's business expansion in the U.S., allowing Luca to offer clinically validated AI offerings in both clinical trials and as digital companions.
In June, ActiGraph rebranded to Ametris to reflect its expanded data and technology platform.
The Ametris rebrand followed ActiGraph's acquisition in January of the Biofourmis Connect digital trial platform, which included the AI-powered Biovitals Analytics Engine and RhythmAnalytics software as a medical device product.
In May, ActiGraph partnered with ZEPHYRx, a provider of decentralized respiratory solutions for clinical research. The partnership expanded digital measurements available for clinical trials to include the crucial data element of respiratory function.
In 2023, Ametris launched the DECODE Nocturnal Scratch working group that was focused on developing a novel, fit-for-purpose digital measure to support patient-focused drug programs for dermatological conditions such as atopic dermatitis and psoriasis.
Other companies that address obesity issues include Lilly, which in 2024 launched a digital health experience dubbed LillyDirect, which offers patients with diabetes, obesity and migraines access to healthcare providers, educational information and a digital pharmacy for select Lilly medicines.
The platform includes LillyDirect Pharmacy Solutions, which allows patients to order Lilly's drugs via a third-party online pharmacy fulfillment service that can deliver to their homes.
In 2023, knownwell launched with $4.5 million in seed funding led by Flare Capital Partners. It offers metabolic health services, including obesity, primary care, nutrition counseling and behavioral health services.
