Enhancing Clinical Trials in Obesity by Integrating Clinical Outcome Assessments and Digital Health Technologies

The development landscape for overweight and obesity therapies is rapidly evolving, shaped by regulatory guidance and advances in how therapeutic value is measured. Increasingly, drug development is moving beyond traditional weight-loss metrics toward a more comprehensive view of patient health — one that prioritizes lived experience, functional ability and quality of life.

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 The FDA’s recent draft guidance on weight-loss therapies continues to prioritize weight reduction as a Phase III primary endpoint but also encourages secondary endpoints that reflect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. This combined approach can strengthen the evidence base, meet validation and usability requirements and enhance trial efficiency, while also supporting market differentiation and clinical adoption.

Attendees will gain practical strategies for designing obesity trials that:

• Align with current regulatory expectations
• Leverage COAs and DHTs in combination to capture meaningful, patient-relevant outcomes
• Anticipate operational considerations that affect implementation and data quality

By the end of the session, participants will be equipped to optimize measurement strategies that address both scientific rigor and the evolving needs of patients and regulators.

Register for this webinar to learn how clinical outcome assessment can be integrated with digital technologies to advance obesity clinical trials.

Speakers

Max Gaitán, Outcomes Researcher, ICON

Max Gaitán is an Outcomes Researcher at ICON, where he develops endpoint strategies with clients deploying digital health technologies in clinical trials. Before 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.

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Céline Desvignes-Gleizes, Outcomes Researcher, Mapi Research Trust

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 disease program to support the identification of suitable COAs for rare disease trials.

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Pat Koochaki, Senior Principal, ICON plc

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.

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