2024 - Optimizing Obesity Trials: Integrating Diverse Endpoints to Holistically Assess Safety and Efficacy of GLP-1 Agonists and Beyond

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.
Keywords: Obesity, Drug Development, Clinical Research, CRO, Clinical Data, Therapeutic Areas, Clinical Endpoints, Clinical Trial Endpoints, Obesity Drug, GLP-1 Agonists, GLP-1 Drugs