In this free webinar, learn about the importance of moving beyond BMI to incorporate a range of biomarkers in clinical trials for obesity to enhance the accuracy of obesity diagnosis, facilitate precision medicine and improve the prevention and treatment of obesity-related diseases. The featured speakers will discuss the reason why the Lancet Diabetes & Endocrinology Commission's key recommendation is to distinguish pre-clinical obesity and clinical obesity. Attendees will gain insight into the novel challenges and opportunities that these evolving questions present in addressing the urgent need for safe and effective therapies for persons living with obesity.
TORONTO, July 3, 2025 /PRNewswire-PRWeb/ -- What Are the Implications of the Lancet Commission's Report on the Definition and Diagnostic Criteria for Obesity?
The webinar explores the limitations of body mass index (BMI) as a sole indicator for obesity in clinical trial design and the potential for more precise diagnostic criteria as suggested by the Lancet Commission's report.1
BMI has long been used for screening obesity due to its ease of measurement and correlation with adiposity at a population level. It remains the gold standard for the characterization of patient populations in clinical trials for regulatory purposes.
Importantly, the recent FDA guidance for industry, "Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction," confirms the continued application of: (i) BMI weight classification for Phase II and III obesity trials in adult populations, and (ii) BMI criteria based on the 2,000 US Centers for Disease Control and Prevention (CDC) growth charts for children and adolescents aged two years and older.2
However, BMI fails to account for individual variations in health risks and does not distinguish between fat mass and fat-free mass. This has led to inaccuracies in obesity classification and the assessment of associated health risks like cardiovascular diseases and type 2 diabetes.
The Lancet Diabetes & Endocrinology Commission, comprising 58 experts from multiple medical specialties and countries, recently published recommendations emphasizing the need for a more nuanced approach to defining and diagnosing obesity. A key recommendation is distinguishing pre-clinical obesity (excess adiposity confirmed by either direct measurement of body fat or at least one anthropometric criterion) and clinical obesity (excess adiposity with evidence of reduced organ or tissue function due to obesity).
Additionally, a recent study by Coral et al. identified discordant profiles within populations, where individuals have higher or lower cardiometabolic risk than expected for their BMI.3 These profiles, representing around 20% of the population, can improve the prediction of major adverse cardiovascular events (MACE) and type 2 diabetes when incorporated into multivariate models. This precision in risk prediction allows for targeted interventions, potentially reducing unnecessary treatments and improving clinical outcomes.
The Lancet Commission's report serves as a pivotal reference for redefining obesity and underscores the need for comprehensive diagnostic criteria that reflect the complex nature of obesity and its associated health risks. The Commission also suggests that future clinical studies should further define criteria for the remission of clinical obesity, making remission an important outcome measure in future clinical trials and other studies of both existing and novel therapeutics.
This webinar, led by two international experts, Dr. Scott Isaacs and Prof. Carel le Roux, will highlight the importance of moving beyond BMI to incorporate a range of biomarkers in clinical trials for obesity. This shift can enhance the accuracy of obesity diagnosis, facilitate precision medicine and improve the prevention and treatment of obesity-related diseases. The expert panel will consider the novel challenges and opportunities that these evolving questions present in addressing the urgent need for safe and effective therapies for persons living with obesity.
Register for this webinar to learn how evolving definitions and diagnostic criteria are reshaping obesity clinical trials — paving the way for more precise patient stratification, targeted interventions and improved outcomes.
Join Scott Isaacs, MD, FACP, FACE, Adjunct Assistant Professor of Medicine, Emory University; President of the American Association of Clinical Endocrinology; Graham C Ellis, MD, Executive Director, Medical Science and Strategies, PPD clinical research business of Thermo Fisher Scientific; and Professor Carel le Roux, Metabolic Medicine, University College Dublin, for the live webinar on Wednesday, July 23, 2025, at 1pm EDT (10am PDT).
For more information, or to register for this event, visit Obesity Clinical Trials: Beyond BMI.
References:
- Rubino F, Cummings DE, Eckel RH, et al. Definition and diagnostic criteria of clinical obesity. Lancet Diabetes Endocrinol. 2025;13(3):221-262. https://doi.org/10.1016/S2213-8587(24)00316-4
- US Food and Drug Administration. Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction; Guidance for Industry. January 2025. Accessed May 30, 2025. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/obesity-and-overweight-developing-drugs-and-biological-products-weight-reduction
- Coral DE, Smit F, Farzaneh A, et al. Subclassification of obesity for precision prediction of cardiometabolic diseases. Nat Med. 2024;31:534-543. https://doi.org/10.1038/s41591-024-03299-7
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