Overview:
The development landscape for overweight and obesity therapies is rapidly evolving, shaped by regulatory guidance and advances in how therapeutic value is measured.
This webinar will explore how Clinical Outcome Assessments (COAs) and Digital Health Technologies (DHTs) are reshaping obesity trials. Historically, these trials have centered on weight reduction and comorbidity risk as primary endpoints. In recent years, however, patient-centered approaches have gained traction, driving the creation of 17 new COAs for obesity research in the past decade, supporting seven FDA and EMA label claims, and prompting the deployment of more than 70 DHTs in pharma-sponsored studies.
Regulatory perspectives are evolving alongside these innovations. The FDA’s recent draft guidance on weight-loss therapies continues to prioritize weight reduction as a Phase 3 primary endpoint but also encourages secondary endpoints that reflect metabolic health and functional outcomes—areas where COAs can directly contribute to labeling claims.
An emerging insight from industry practice is that COAs and DHTs are not competing methodologies. When integrated thoughtfully, they can generate complementary evidence—pairing subjective patient-reported insights with objective, technology-enabled measures.
Attendees will learn:
- Patterns in the current use of COA and DHT deployment in clinical trials for obesity
- Regulatory factors affecting COA and DHT deployment across the drug development lifecycle
- Complementary strategies for COA and DHT selection to add context and differentiate a product on the market
Speakers:
Max Gaitán
Max Gaitán is an Outcomes Researcher and develops endpoint strategies with clients deploying digital health technologies in clinical trials. Prior to joining ICON, Max was a Research Lead at HumanFirst, where he developed Atlas, the industry’s leading platform for evaluating and selecting digital health technologies. Max’s background is in clinical exercise research with a focus on metabolic and neurodegenerative diseases.
Céline Desvignes-Gleizes
Céline Desvignes-Gleizes is a patient-centred outcomes specialist, facilitating the exchange and access of information on Clinical Outcomes Assessments (COA). She leads a rare diseases program to support the identification of suitable COAs for rare disease trials.
Pat Koochaki
Pat Koochaki is a Senior Principal in the Patient Centred Outcomes group with 30+ years of outcomes research experience. She is passionate about integrating patient experience into all facets of clinical research and conducted some of the first interviews with clinical trial patients over 20 years ago. Pat has expertise in developing COA endpoint strategies, dossier development, and mixed methods research.