By Clinical Research Staff 

March 10, 2026 | As the obesity drug market accelerates, clinical trial design is coming under renewed scrutiny, with growing pressure on sponsors to demonstrate benefits that extend beyond weight loss. The Digital Endpoint Collaboration for Outcomes Development (DECODE) Obesity initiative and cross-industry consortium, led by Ametris, is looking to validate new clinical outcome measures that capture how patients function and feel while on treatment. Regulators, payers, and patients are increasingly asking whether therapies—particularly the highly popular GLP-1–based drugs—translate into other areas of diseases and health. DECODE Obesity is working to generate regulatory-grade evidence for digital endpoints that assess physical activity, functional mobility, and sleep. 

The consortium includes Roche, Eli Lilly, Novo Nordisk, and AstraZeneca, each of which will have early access to the validated algorithm and evidence generated from an ongoing observational validation study. Notably, they will also be participating in conversations with regulators, including the Food and Drug Administration (FDA) and the European Medicines Agency, to align evidentiary expectations. 

For the study, 30 patients with obesity are being recruited in Massachusetts who agree to one month of continuous, at-home monitoring using wearable sensors as well as in-lab functional testing. The goal is not to test a specific drug, but to better characterize the meaningfulness of the measures to participants as well as usability of a wearable device to do the measurements, according to Sylvain Zorman, director of digital solutions strategy at Ametris.  

A key component of the study focuses on patient engagement. Participants complete end-of-study questionnaires to assess usability and burden, ensuring that a wearable device such as this can fit into daily life. Rather than abstract metrics such as total step counts, investigators are exploring more clinically meaningful constructs—for example, the longest continuous walking bout a patient can manage—which may better reflect functional improvement in real-world settings. 

The emphasis on function is particularly relevant given concerns about lean muscle loss associated with GLP-1 therapies, with some studies suggesting that it may account for up to 40% of weight loss. By capturing mobility and activity data alongside weight change, sponsors hope to better understand the net clinical impact of these drugs and to differentiate products in an increasingly crowded pipeline. 

Building on precedent set by DECODE’s earlier work validating nocturnal scratch as an endpoint in dermatology trials, Ametris and its partners will seek early and sustained feedback from health authorities. Those discussions are aligned with broader FDA initiatives under the Prescription Drug User Fee Act and the agency’s 2022 guidance on digital health technologies in clinical research. 

To read the full story written by Deborah Borfitz, visit Diagnostics World News.