In this free webinar, learn about how obesity and diabetes drug development requires monitoring for hypoglycemia with a blood glucose meter (BGM) for regulatory submission. Attendees will learn how GLP-1 agonists and other obesity drugs can change body composition, liver fat density and the brain's response to food cues. The featured speakers will discuss how loss of muscle poses a significant health risk for individuals experiencing weight loss. The speakers will also share how obesity drug trials often include patients with pre-existing cardiovascular disease, which requires robust cardiac safety testing.
TORONTO, Oct. 22, 2024 /PRNewswire-PRWeb/ -- 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 ofmany 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-1s 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.
Join experts from Clario, Todd Rudo (Moderator), MD, Chief Medical Officer; Paul Strumph, MD, Diabetes & Metabolism Key Opinion Leader, Clinical Science & Consulting; Fabian Chen, MD, VP and Deputy CMO, Cardiology; and Mark W. Tengowski, DVM, MS, PhD, Director Medical & Scientific Affairs, Medical Imaging, for the live webinar on Tuesday, November 12, 2024, at 11am EST (4pm GMT/UK).
For more information, or to register for this event, visit Optimizing Obesity Trials: Integrating Diverse Endpoints to Holistically Assess Safety and Efficacy of GLP-1 Agonists and Beyond.
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