An estimated 1 billion people are living with obesity worldwide, with adult obesity rates having doubled since 1990 and quadrupled in children and adolescents. Individuals with obesity are at an increased risk of cardiovascular disease, diabetes and certain cancers, among other comorbidities. This increased prevalence combined with the clinical and commercial success of glucagon-like peptide (GLP)-1 agonists for treating both obesity and diabetes has led to a multitude of clinical trials assessing the safety and efficacy of new therapies.
With these studies, researchers are identifying risks and benefits across health disciplines, including cardiovascular, metabolic, mental health, sleep, endocrine and gastrointestinal impacts. For these reasons, it is essential for drug manufacturers to incorporate comprehensive assessments of safety and efficacy to obtain regulatory approval and maximize market opportunities by generating robust data supporting secondary efficacy claims.
Designing a holistic obesity trial is complex due to the need for endpoints across multiple disciplines, including medical imaging, electronic outcomes assessments and cardiac endpoints for efficacy and safety:
- Medical Imaging: Advanced imaging modalities can analyze changes in body composition and liver fat levels over time as well as evaluating brain response to food cues. A key consideration is monitoring for muscle loss, a significant risk for individuals experiencing weight loss
- eCOA: Hypoglycemia data are essential in diabetes and obesity trials for assessing drug safety, and hypoglycemia diaries are a robust and widely accepted method to collect and report this data type. Further, observational data have identified a potential association between GLP-1 medications and risk of suicidal ideation and behavior, necessitating a robust monitoring strategy in prospective clinical trials
- Cardiac Safety and Efficacy: Cardiovascular (CV) safety is a critical component of any clinical trial, particularly in high-risk populations of patients who may have pre-existing CV disease. This necessitates appropriate baseline cardiac testing and ongoing monitoring to accurately determine any drug-related risks. When considering efficacy, some GLP-1’s have been associated with a reduction in major adverse cardiovascular events (MACE) such as congestive heart failure
Register for this webinar today to delve into the intricacies of designing holistic obesity trials that incorporate multi-disciplinary endpoints.
Speakers
(Moderator) Dr. Todd Rudo, MD, Chief Medical Officer, Clario
Dr. Todd Rudo is EVP and Chief Medical Officer at Clario, providing medical and scientific leadership across the organization. He has nearly 20 years of clinical cardiology and pharmaceutical research experience, with a career predominantly focused on drug safety. Dr. Rudo has board certifications in cardiology, cardiac electrophysiology, nuclear cardiology, adult echocardiography and internal medicine.
His team provides expert consulting to clients on scientific and regulatory strategy and ensures Clario’s product portfolio is scientifically robust, generating high-quality clinical trial endpoint data. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials while maintaining focus on the customer experience, including minimizing patient and site burden.
Message Presenter
Dr. Paul Strumph, MD, Diabetes & Metabolism Key Opinion Leader, Clinical Science & Consulting, Clario
Dr. Paul Strumph has been advising Clario on diabetes, metabolism and obesity clinical development strategy since 2021. He brings more than 20 years of experience in pharmaceutical development. Recent positions include CMO of Seraxis Inc, Metavant Sciences and JDRF. He has also served as Vice President, Clinical Development, at Lexicon Pharmaceuticals where he led global clinical development from early phase 2 work through NDA and MAA filings achieving the EU approval of sotagliflozin, an oral adjunct to insulin in type 1 diabetes.
At Quintiles (now IQVIA) he was the Founder and Chair of the Diabetes Center of Excellence and served as the Diabetes Strategy Lead and North America CMO. Paul received his undergraduate degree from Wesleyan University, his MD with distinction in research from the University of Rochester School of Medicine & Dentistry and completed residency training in combined Internal Medicine and Pediatrics at Emory University, and combined Adult and Pediatric Endocrinology Fellowship at University of Pittsburgh Medical Center (UPMC) and Children’s Hospital of Pittsburgh.
Message Presenter
Dr. Fabian Chen, MD, VP and Deputy CMO, Cardiology, Clario
Dr. Fabian Chen is Deputy Chief Medical Officer – Cardiology and Vice President at Clario. In addition to providing leadership for Clario’s Cardiac Safety department, Dr. Chen provides expert consultation to clients on scientific and regulatory strategy. Dr. Chen has nearly 20 years of clinical cardiology and pharmaceutical research experience.
Recent positions include Chief Medical Officer at the University of Pennsylvania Gene Therapy Program and Vice President of Clinical Development at Rocket Pharmaceuticals. Dr. Chen also has over 10 years of experience in both early and late-stage clinical development working at Merck and Novartis Pharmaceuticals.
Fabian received his undergraduate degree at Harvard College and his MD PhD at Yale University. He completed his internal medicine and cardiology training at the University of Pennsylvania School of Medicine.
Prior to entering the pharmaceutical industry, Fabian was on the faculty member of the departments of Medicine, Pediatrics and Molecular & Cellular Physiology at the University of California Los Angeles.
Message Presenter
Dr. Mark W. Tengowski, DVM, MS, PhD, Director Medical & Scientific Affairs, Medical Imaging, Clario
Dr. Mark W. Tengowski’s current responsibilities include clinical development and trial experiences in SLD/MASH (formerly NAFLD/NASH) and biliary cholangitis; Crohn’s disease, perianal fistula and ulcerative colitis; osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, spondyloarthritis, psoriatic arthritis and bone age; and women’s health including endometriosis, uterine fibroids, endometrial thickness and breast volume and density.
Using various MRI, XR, and CT imaging and clinical response assessments, Dr. Tengowski began his industry career with Pfizer (1999-2007) working in Drug Safety Evaluation (Groton) and Global Clinical Technologies (Ann Arbor). In 2007, he began his imaging core lab service starting at VirtualScopics (2007-2013) and Clario (formerly Bioclinica/ERT, 2016 to present).
Dr. Tengowski is a 1992 graduate of the University of Wisconsin School of Veterinary Medicine with graduate training in Pharmacology (MS, 1994) and Endocrinology & Reproductive Physiology (PhD, 1997) both from the UW-Madison Graduate School. Dr. Tengowski holds veterinary medical licenses in WI and NY and is accredited by the USDA (Category II).
Message PresenterWho Should Attend?
This webinar will appeal to:
- CEOs/Chief Medical Officers/Chief Scientific Officers
- Clinical operations/Clinical development/Clinical research
- Clinical Pharmacologists/Clinical Scientists/Imaging Scientists
- Medical Affairs
- Medical Monitor
- TA Experts (obesity, diabetes, metabolic)
What You Will Learn
Attendees will learn about:
- How obesity and diabetes drug development requires monitoring for hypoglycemia with a blood glucose meter (BGM) for regulatory submission
- How GLP-1 agonists and other obesity drugs can change body composition, liver fat density and the brain’s response to food cues
- How lose of muscle poses a significant health risk for individuals experiencing weight loss
- How obesity drug trials often include patients with pre-existing cardiovascular disease, which requires robust cardiac safety testing
Xtalks Partner
Clario
Clario is a leading healthcare research and technology company that generates the highest quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence-generation solutions that combine eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. Clario’s science, technology, and operational experts have helped deliver over 26,000 trials and contributed to over 800 regulatory approvals in more than 100 countries. For more than 50 years, we have provided deep scientific expertise and the broadest endpoint technologies to help transform lives around the world.
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