GLP-1 Agonist Development: Endpoint Strategies to Help Differentiate Your Drug

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.

Keywords: Obesity, Diabetes, eCOA, eCOA Technology, Clinical Endpoints, Endpoints, Clinical Trial Endpoints, Digital Endpoints, GLP-1, GLP-1 Agonist, electronic Clinical Outcome Assessments (eCOA), GLP-1 Agonists, GLP-1 Drugs

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Life Sciences,Clinical Trials,Pharmaceutical Regulation,Drug Discovery & Development