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.
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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.
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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.
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
Speakers
Scott Isaacs, MD, FACP, FACE, Adjunct Assistant Professor of Medicine, Emory University; President of the American Association of Clinical Endocrinology
Dr. Scott Isaacs is a board-certified endocrinologist in Atlanta, Georgia. He is Adjunct Assistant Professor of Medicine at Emory University and President of the American Association of Clinical Endocrinology (AACE). His practice focuses on diabetes, obesity medicine, steatotic liver disease, cardiometabolic disease and general endocrinology.
Dr. Isaacs attended medical school at Emory University and continued for residency and fellowship in endocrinology. He is a diplomate of the American Board of Obesity Medicine and the American College of Physicians. He is a two-time Past President of the Georgia Chapter of the American Association of Clinical Endocrinologists and is a Past President of the Atlanta Chapter of the American Diabetes Association. He is the co-chair of the AACE NAFLD Clinical Practice Guidelines cosponsored by the AASLD and an author of the AACE Diabetes Algorithm.
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Graham C Ellis, MD, Executive Director, Medical Science and Strategies, PPD clinical research business of Thermo Fisher Scientific
As Executive Director of Medical Science and Strategy, Dr. Graham C Ellis is responsible for the diabetes and metabolic disease portfolio and also serves as a voting member of the business’ Human Safety Committee. His more than 20 years of experience in clinical research includes acting as PI in more than 200 Phase II and III international clinical trials in a wide range of therapy areas, including large numbers of studies on T2 diabetes, metabolic disease, diabetic complications and obesity.
Previously, he enjoyed 20-plus years as a Consulting Physician in diabetes and metabolic disease practice and was a Founder and Director of HCTC, a large and successful clinical research centre in South Africa until it was acquired by Synexus in 2014.
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He also serves on a global expert panel of a large, recently completed GLP-1 CVOT study in non-diabetic obese subjects. In addition to being published in peer-reviewed diabetes and osteoporosis journals, he is a reviewer for Diabetes, Obesity and Metabolism and has spoken at numerous local and international conferences.
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Professor Carel le Roux, Metabolic Medicine, University College Dublin
Professor Carel le Roux graduated from medical school in Pretoria South Africa, and completed his specialist training in metabolic medicine at St Bartholomew’s Hospital and the Hammersmith Hospital. He obtained his PhD from Imperial College London, where he later took up a faculty position. Professor le Roux moved to University College Dublin for the Chair in Chemical Pathology and Metabolic Medicine and he is now a Director of the Metabolic Medicine Group. He also holds the position of Professor of Metabolic Medicine at Ulster University and Extra-ordinary Professor of Chemical Pathology at University of Pretoria.
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Who Should Attend?
This webinar will appeal to:
- Biotech and biopharma sponsors interested in obesity studies
- Healthcare Providers and Clinicians involved in the management of clinical research patients for obesity, diabetes and metabolic diseases
- Clinical Research Investigators and Site Directors
What You Will Learn
Attendees will gain insights into:
- 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 reason why the Lancet Diabetes & Endocrinology Commission’s key recommendation is to distinguish pre-clinical obesity and clinical obesity
- 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
Xtalks Partner
The PPD clinical research business of Thermo Fisher Scientific Inc.
The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, enables customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, their capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, novel approaches to patient recruitment and investigator sites, and comprehensive laboratory services. Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, they serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, they apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.
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