In this free webinar, learn strategies for leveraging innovative endpoint solutions to enhance the safety, efficacy and patient-focused value of GLP-1 clinical trials. The featured speakers will discuss how obesity and diabetes drug development requires monitoring hypoglycemia using a blood glucose meter (BGM) for regulatory submission and how 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, attendees will learn why risk monitoring with a validated instrument is essential in prospective studies to understand any potential risks and to protect participant safety. The speakers will also discuss why leveraging novel imaging modalities to quantify muscle, fat and bone mass changes accurately is an essential element of an obesity drug development program, and more.
TORONTO, Feb. 4, 2025 /PRNewswire-PRWeb/ -- 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.
Join experts from Clario, Jessica Emerson, PhD, MS, Senior Scientific Advisor, eCOA Science and Consulting; Mark W. Tengowski, DVM, MS, PhD, Director Medical & Scientific Affairs, Medical Imaging; and Judith Narisi, BSN, RN, Senior Medical Scientific Affairs Associate, for the live webinar on Tuesday, February 25, 2025, at 11am EST (4pm GMT/UK).
For more information, or to register for this event, visit GLP-1 Agonist Development: Endpoint Strategies to Help Differentiate Your Drug.
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