How Parexel Supports Cross Functional Trials for Emerging GLP-1 Therapies

In an interview with Applied Clinical Trials, Shipra Patel, global therapeutic area section head for endocrinology and global head of pediatrics at Parexel, discussed the evolving landscape of obesity drug development and what it takes to stand out in a field crowded with more than 90 active sponsors. Patel emphasized the importance of therapeutic depth, cross-functional collaboration, and the strategic use of real-world evidence to design safer, more effective clinical trials—particularly as GLP-1 therapies expand into new indications such as Alzheimer’s, addiction, and MASH. She also shared how Parexel is adapting its clinical infrastructure to meet the growing complexity of this space, while keeping long-term patient engagement and global data integrity at the forefront.

ACT: Given the expanding use of GLP-1 therapies across indications like Alzheimer’s, addiction, and MASH, how does Parexel structure its clinical teams to support trials spanning multiple therapeutic areas?

Patel: One of our strengths at Parexel is our therapeutic alignment. We have dedicated franchises across multiple therapeutic areas—endocrinology, cardiology, pulmonary, psychiatry, and more. This structure allows us to bridge gaps between indications by encouraging cross-functional collaboration.

For example, I lead endocrinology, but I regularly connect with my counterparts in cardiology, pulmonary, and psychiatry. This ongoing dialogue allows us to share insights, apply clinical trial experiences across areas, and develop unified strategies for compounds with relevance in multiple indications—like GLP-1s.

In addition to our therapeutic area heads, we have study design and biostatistics experts who provide critical input on protocol development and trial structure. This integrated approach helps ensure we design efficient, insightful studies, even when trials span diverse and complex therapeutic spaces.

Full Interview Summary: With more than 90 sponsors now driving obesity drug trials, standing out in this competitive space requires deep therapeutic expertise and cross-functional coordination. According to leaders at Parexel, the key differentiator for a standout research partner lies in a nuanced understanding of the evolving obesity drug market—particularly GLP-1 therapies. These compounds, initially developed for diabetes and obesity, are now being investigated for a broad range of indications including MASH, Alzheimer’s, addiction, Parkinson’s, and sleep apnea. To support this complexity, Parexel has implemented a GLP-1 task force—an internal expert group that helps clients stay competitive across the drug development lifecycle.

To handle GLP-1 trials spanning multiple therapeutic areas, Parexel relies on a therapeutically aligned model, connecting area leads across endocrinology, cardiology, psychiatry, and pulmonology. These cross-disciplinary teams collaborate to translate clinical trial learnings between indications and optimize study designs for similar mechanisms of action.

Real-world evidence (RWE) plays a central role in addressing the safety concerns linked to rising off-label GLP-1 use, even among patients with normal BMI. RWE shows many patients discontinue treatment early, often due to costs or tolerability issues—particularly gastrointestinal side effects. Flexible dosing, even below the maximum level, may still yield metabolic benefits, offering a new lens for trial design.

Parexel has leveraged RWE to identify non-traditional patient populations and refine trial protocols—for instance, by pinpointing regions with high use of GLP-1s to aid recruitment for switch-over studies. Looking ahead to 2050, long-term patient retention, better compliance tracking, and global data accuracy will be essential to compare therapies and identify long-term leaders in the obesity space. Innovations in AI and global patient engagement will be critical in sustaining participation and capturing meaningful safety outcomes.