ACT Brief: Adaptive Trial Designs, Wegovy’s MASH Breakthrough, and Lilly’s Expanding Partnerships

This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, highlight expert perspectives, and keep you current on what’s moving the industry.

• We begin with insights on evolving clinical trial designs that are propelling the next generation of precision medicine. A review in Signal Transduction and Targeted Therapy highlights how basket, umbrella, and platform trials are transforming drug development efficiency and flexibility. Basket trials test one therapy across multiple cancers sharing a biomarker, while umbrella trials evaluate several targeted treatments within one disease type. Platform trials take it further, using a master protocol to add or remove study arms as data evolve—cutting years off development timelines. Researchers are now looking ahead to “precision medicine 2.0,” emphasizing AI-driven design models that integrate real-world data to optimize recruitment and trial feasibility.
• Next, Novo Nordisk presented new findings from its Phase III ESSENCE trial showing that Wegovy may reduce liver injury in patients with metabolic dysfunction-associated steatohepatitis, or MASH. The data revealed that semaglutide 2.4 mg improved liver health parameters even at low levels of weight loss. Investigators noted that the results suggest a direct hepatic benefit beyond Wegovy’s weight-loss effects, expanding its potential as a treatment for cardiometabolic and inflammatory conditions.
• Finally, Eli Lilly announced two new collaborations aimed at expanding its reach into genetic and RNA-based medicine. The company is partnering with SanegeneBio to develop RNA interference therapies for metabolic diseases using the company’s proprietary Ligand and Enhancer Assisted (LEAD) platform, designed for subcutaneous dosing just twice a year. In a separate agreement, Lilly is joining forces with MeiraGTx to co-develop ophthalmology gene therapies, including exclusive rights to MeiraGTx’s AAV-AIPL1 program for Leber congenital amaurosis and its riboswitch technology for controlled gene expression. Together, the deals total more than $1.6 billion in potential milestone payments and strengthen Lilly’s position in advanced therapeutic modalities.

That’s all for today’s ACT Brief. Join us next week for more insights shaping the future of clinical operations and drug development. Thanks for listening.