The development of GLP-1 agonists for diabetes and obesity management continues to transform patient care, but in today’s competitive landscape, standing out is more critical than ever.
In this webinar, the expert speakers will share strategies for leveraging innovative endpoint solutions to enhance the safety, efficacy and patient-focused value of GLP-1 clinical trials. Attendees will gain valuable insights into how digital endpoints can provide high-quality data to detect safety concerns, evaluate therapeutic benefits and generate compelling trial outcomes.
Monitoring patient-reported outcomes (PROs) through electronic Clinical Outcome Assessments (eCOA) offers a powerful way to differentiate treatments by showcasing their real-world impact on weight-related quality of life (QOL). Implementing electronic hypoglycemia diaries alongside blood glucose meters allows for efficient, real-time data collection, which is essential for regulatory submissions.
Additionally, addressing concerns such as potential links between GLP-1 therapies and suicidal ideation requires careful monitoring using validated tools. These strategies are key to ensuring participant safety and building confidence in a treatment’s safety profile.
Body composition endpoints derived from imaging can provide valuable insights into both the benefits and potential risks of GLP-1 agonists. While these therapies are effective at promoting weight loss, unintended reductions in muscle mass or bone density could pose health risks. Advanced imaging technologies enable precise measurement of muscle, fat and bone density, allowing sponsors to document therapeutic gains — such as reductions in visceral and subcutaneous fat — while also mitigating risks. These insights are critical for creating a well-rounded safety and efficacy narrative to differentiate a drug.
Cardiovascular outcomes, particularly Major Adverse Cardiovascular Events (MACE), offer another avenue for differentiation. Demonstrating a MACE benefit can significantly increase the value of GLP-1 therapies by highlighting their ability to address broader cardiometabolic risks. Expert adjudication of cardiovascular endpoints ensures the collection of robust, regulatory-grade evidence to meet approval requirements and support stakeholder decisions.
While the full breadth of cardiovascular benefits of GLP-1 receptor agonists in patients without diabetes remain under investigation, accurate characterization of clinical events will be vital to understanding these therapies’ full impact.
This webinar provides an opportunity to explore how innovative digital and imaging endpoints can maximize the value of your GLP-1 clinical trials. Attendees will learn how to enhance differentiation, ensure regulatory compliance and drive success in this rapidly evolving field.
Speakers
Jessica Emerson, PhD, MS, Senior Scientific Advisor, eCOA Science and Consulting, Clario
Dr. Jessica Emerson is a behavioral scientist with over 15 years of experience in behavioral and social science research focusing on the role of technology in measuring and intervening on health behaviors to improve health among patients with obesity and diabetes. She also has extensive experience in eCOA database design and management. Jessica has been with Clario since 2021. As a Senior Scientific Advisor, she supports sponsors and CROs in eCOA design best practices and preliminary study set-up to optimize the reliability of eCOA data.
Jessica received her undergraduate degree in psychology from Tufts University, and she completed her MS in Cognitive Science and her PhD in Behavioral and Social Health Sciences at Brown University. She completed a post-doctoral research fellowship at the Miriam Hospital at the Diabetes and Weight Loss Research Center.
Message Presenter
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 both pharmacology (MS, 1994) and endocrinology and reproductive physiology (PhD, 1997) from the UW-Madison Graduate School.
Dr. Tengowski holds veterinary medical licenses in WI and NY and is accredited by the USDA (Category II). He is a member of the AASLD.
Message Presenter
Judith Narisi, BSN, RN, Senior Medical Scientific Affairs Associate, Clario
Judy Narisi is a seasoned healthcare professional with over two decades of experience in clinical research. Trained as a critical care RN, Judy’s research journey began in 2004 as a Study Coordinator, progressing to safety event case management and ultimately event adjudication in 2006. She has held key roles at PharmaNet, Johnson & Johnson and ICON, where her team reviewed 9,000+ cases for a large CV outcomes trial in patients with type II diabetes at high CV risk that compared liraglutide with placebo using a primary composite endpoint of three-point major adverse CV events.
Judy began her tenure at Clario as a Senior Director of adjudication services and currently serves as a Senior Medical Affairs Associate for Adjudication. She has successfully managed a team that has been effective in rescuing several large programs and contributed to the approval of several pharmaceutical drugs supported by the adjudication of thousands of events. Judy received her nursing degree from Gwynedd Mercy University in Pennsylvania.
Message PresenterWho Should Attend?
This webinar will appeal to those in the following fields or having the following titles:
- CEOs/Chief Medical Officers/Chief Scientific Officers
- Clinical Data Managers/Clinical IT/Clinical Monitoring
- Clinical Operations (early phase)/Clinical Operations/Clinical Development
- Clinical Research/Clinical Pharmacologists/Clinical Scientists
- Data Science/Health Economics and Outcomes Research
- Imaging Scientists/Medical Affairs/Medical Monitor/Head of Development for Program
- PK Experts/Protocol Managers/Regulatory Affairs
- Sr. Managers, Trial Initiation
What You Will Learn
Attendees will learn about:
- Obesity and diabetes drug development requires monitoring for hypoglycemia with a blood glucose meter (BGM), for regulatory submission. An electronic hypoglycemia diary paired with BGM enables the straightforward collection of both glucose and symptom data concurrently.
- In light of recent concerns about associations between GLP-1 agonists and suicidal ideation, risk monitoring with a validated instrument is essential in prospective studies to understand any potential risks, and for protecting participant safety.
- GLP-1 agonists and other weight loss medications can have undesirable negative impact on muscle mass and/or bone density, while also causing benefits of reduced visceral and subcutaneous fat.
- For individuals experiencing weight loss, loss of muscle and bone density pose potential health risks. Leveraging novel imaging modalities to quantify muscle, fat and bone mass changes accurately is an essential element of an obesity drug development program.
- Subject clinical events must continue to be monitored and reviewed as long-term data becomes available. It is unknown whether GLP-1 receptor agonists can reduce the cardiovascular risk associated with overweight and obesity without diabetes. There is still a role for CV endpoint adjudication in demonstrating a MACE benefit or risk (or defined otherwise).
Xtalks Partner
Clario
Clario is a leading provider of endpoint data solutions that generate high-quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence generation solutions that combine eCOA, cardiac solutions, medical imaging, precision motion, and respiratory endpoints.
Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries. Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2012.
For more information, go to Clario.com or follow us on LinkedIn.
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