Obesity Trials: Scaling Operations for High-Demand Therapeutics

In a recent video interview with Applied Clinical Trials, Heidi Chen, Associate Director of Research & Commercial Services at Citeline, discussed findings from the company’s 2025 Annual Clinical Trials Roundup. She outlined how personalized and biomarker-based therapies are creating opportunities and challenges for trial design, especially in rare disease populations, and highlighted the use of historical controls and real-world evidence to support targeted development. She also explained the growth in CNS, autoimmune, and obesity trials, noting the operational implications for study design, site selection, and adoption of decentralized and hybrid trial models. Finally, she discussed how sponsors and CROs are navigating new ICH GCP guidelines while continuing to innovate and maintain data integrity, emphasizing resilience and the ongoing expansion of the clinical pipeline.

The below interview transcript was lightly edited for clarity.

ACT: Obesity entering the global top 10 for trial activity reflects the surge in GLP-1 research. How are sponsors adapting operations to keep pace with such high-demand therapeutic areas?

Chen: Yes, obesity is experiencing accelerated growth over the last couple of years. According to our sister product Evaluate, the obesity market is expected to reach $126 billion by 2030. We are already seeing blockbusters like Wegovy, Mounjaro, and Ozempic leading the renaissance in anti-obesity development.

What do sponsors have to do to keep up? Well, there's plenty. Not only do they have to scale up manufacturing so that the drug is accessible as widely as possible, but they also need to invest in ways to improve or streamline their supply chains, while continuing to negotiate reimbursements with payers. On the R&D front, they must keep innovation running and diversify strategies, such as new delivery or dosing technologies, exploring new targets, and developing new combinations, for example, with amylin agonists to target comorbidities and reduce GI-related side effects. Big players in this area, like Novo Nordisk, Eli Lilly, and AstraZeneca, are already actively working with these approaches.