Ametris starts obesity digital endpoint project with pharma

Ametris has launched a collaboration with pharma companies that aims to show how digital endpoints can be used to advance the development of new obesity therapies.

The company – formerly known as ActiGraph and most known for its development of wearable digital health technologies (DHTs) – is leading the DECODE Obesity project with participation from Novo Nordisk, Eli Lilly, and Roche.

A new obesity working group has been set up to focus on "evidence generation and regulatory engagement" to enhance clinical programmes in obesity by layering in assessments of physical activity and function using wearable DHTs.

The company is asking for teams from other groups that are investigating new weight-loss therapies to join the collaboration, to see how data from wearable technologies can be harnessed to deliver measurements of patient mobility and function in the context of clinical research.

Physical activity is one of the key factors in sustaining weight loss, preserving muscle mass, and achieving long-term health benefits.

"Continuous and real-life measures of these important covariates and additional clinically meaningful outcome measures can help assess the efficacy of new obesity treatments," said Ametris in a statement.

DECODE Obesity is its second 'pre-competitive' digital endpoint project, coming two years after exploring the use of DHT wearables to measure nocturnal scratch in people with dermatological conditions.

The projects tie in with recommendations published by the FDA last year on the use of DHTs for remote data gathering in clinical trials, and Ametris says its goal is "uniting pharmaceutical members to accomplish this research collaboratively."

The working group will focus its efforts in three areas, namely: exploring the use of physical activity and function and sleep measures as endpoints in clinical trials; working out how to incorporate patient voices in development programmes; and obtaining 'buy-in' from regulators in the US and Europe on the resulting strategy for the use of wearable DHTs.

The project already has heavyweight industry backing in Novo Nordisk and Lilly, which currently dominate the obesity market with their GLP-1 agonist-based therapies Wegovy (semaglutide) and Zepbound (tirzepatide), respectively, while Roche is striving to break into the category with multiple candidates in clinical testing.

"From experience, we know that there is a need for generating patient-centred novel endpoints, and we look forward to this industry collaboration," said Novo Nordisk's head of regulatory, quality and clinical reporting, Mads Frederik Rasmussen.

"It is important that we get this right, so we can collect more accurate data, benefitting patients around the world."