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Recent trials of GLP-1 receptor agonist-based therapies using weight loss primary endpoints have shown remarkable efficacy that approaches that of bariatric surgery (~20–25 percent compared to 25–30 percent with bariatric surgery).
GLP-1 receptor agonist-based therapies have also shown compelling benefits on other obesity comorbidities such as glycaemic control in type 2 diabetes, cardiovascular disease risk, progression of chronic kidney disease, obstructive sleep apnea and metabolic-dysfunction associated steatotic liver disease.
Although changes in fat distribution from GLP-1 receptor agonist-based therapies are key to understanding many of the health outcome benefits, the impact of skeletal muscle loss on long-term health outcomes remains to be clarified. While skeletal muscle loss is not specific to GLP-1 receptor agonist-based therapies, the degree of weight loss compared to other anti-obesity medications (AOMs) has exposed the limitations of using weight change as a primary endpoint in clinical trials and has highlighted the need for including accurate measurements of changes in muscle mass and function in AOM clinical trials.
The evolving requirement for accurate assessment of body composition (BC) in clinical trials is further driven by:
- The variability of changes in fat loss and BC changes to different GLP-1 receptor agonist-based therapies
- The variable changes in BC of diverse ethnic and racial populations in response to GLP-1 receptor agonist-based therapies
- The expansion of treatment populations by GLP-1 receptor agonist-based therapies to include adolescents with obesity
- The development of new therapies aimed at preserving muscle mass and function
- Understanding changes in regional adiposity such as pathogenic visceral adipose tissue, liver adipose tissue and epicardial adipose tissue
In this webinar, the speakers will review recent clinical trial data that represents the current state of scientific knowledge and evaluate the impact of the data on loss of muscle mass following GLP-1 receptor agonist-based therapies and the need for accurate and tailored assessments of BC in clinical trials.
Register for this webinar today to delve into the latest clinical trial data on GLP-1 receptor agonist-based therapies and their impact on weight loss and body composition.
Speakers
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Dr. 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.
Dr. Ellis is a founding member of the Centre for Diabetes and Endocrinology (CDE) and a member of the Society for Endocrinology, Metabolism and Diabetes of South Africa (SEMDSA). He is a council member of the National Osteoporosis Foundation of South Africa (NOFSA), an advisory board member and a Hon Research Associate in the Faculty of Science at Stellenbosch University, South Africa.
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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Dr. Nathan Ming-Yu Liu, MD, MTM, Associate Medical Director, Pharmacovigilance, PPD clinical research business of Thermo Fisher Scientific
Dr. Nathan Ming-Yu Liu is a motivated, customer-focused Associate Medical Director with more than 10 years of clinical experience in general pediatrics and 6 years in pediatric endocrinology. He has in-depth knowledge of clinical trials in pediatric, endocrinology and rare disease and is responsible for patient enrollment, implementation of the study protocols and clinical monitoring.
He also worked as a Medical Educator for medical students, pediatric residents, endocrinology fellows and clinical staff. Dr. Liu holds an MD degree from Kaohsiung Medical University, Taiwan, and a Master’s degree in Translational Medicine from the University of California, Berkeley & University of California, San Francisco.
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Dr. Donna H. Ryan, MD, Professor Emerita, Pennington Biomedical Research Center, Baton Rouge, Louisiana
Dr. Donna H. Ryan is Professor Emerita at Pennington Biomedical in Baton Rouge, LA, USA, where she had a 25-year career in clinical research in obesity. She was an Investigator on POUNDS Lost, Look AHEAD, DPP, DASH and many other studies of the health benefits of weight loss by diet, lifestyle intervention and medications.
Most recently, she was the co-Chair of the SELECT Steering Committee, the first cardiovascular outcome trial to demonstrate cardiovascular event reduction in persons with obesity without diabetes. She has been an active member and Former President of The Obesity Society (North America) and World Obesity Federation. She serves on Safety Monitoring Committees for setmelanotide and several GLP-1 RA- related agents.
Dr. Ryan who has more than 300 publications, is a frequent speaker on obesity and diabetes treatments and remains an active consultant and advisor to companies developing drugs, devices, lifestyle programs and medical approaches to obesity management.
Who Should Attend?
This webinar will appeal to:
- Biotech and biopharma sponsors interested in obesity and GLP-1 receptor agonist-based assets and companies involved with BC analysis
- 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 impact of GLP-1 receptor agonist-based therapies on skeletal muscle
- How weight loss-induced sarcopenia affects health and quality of life, especially in elderly persons
- The challenges resulting from GLP-1 receptor agonist-based changes in BC on the design and endpoints of clinical trials
Xtalks Partner
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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