ACT Brief: FDA Approval of Oral Wegovy, 2025’s Most-Read ACT Coverage, and Data Quality as the Foundation for AI

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• The FDA has approved Novo Nordisk’s oral Wegovy pill, marking the first oral GLP-1 therapy for chronic weight management and an indication to reduce major adverse cardiovascular events in adults. The decision is supported by results from the Phase III OASIS 4 trial, a 64-week randomized, double-blind study evaluating once-daily oral semaglutide 25 mg in adults with obesity or overweight and weight-related comorbidities. The trial demonstrated significant weight loss versus placebo and showed improvements across cardiometabolic risk factors, with a safety profile consistent with prior semaglutide studies.
• On ACT, we have released a recap of our five most-read articles in 2025, highlighting recurring themes shaping the clinical research landscape. Topics included large-scale adoption of generative AI in regulatory writing, the impact of US DEI policy changes on trial diversity, increased FDA scrutiny of trial design, expanded use of real-world evidence in regulatory decisions, and the economic pressures reshaping rare disease and gene therapy development.
• A new Pharm Exec feature article examines how fragmented and low-quality data continue to limit the effective use of AI in clinical trials. The piece outlines challenges integrating real-world data with traditional trial datasets, citing data silos, inconsistent standards, and manual reconciliation as persistent barriers. It emphasizes standards-based data harmonization using frameworks such as CDISC and FHIR as a prerequisite for real-time analytics, regulatory readiness, and scalable AI deployment across the clinical development lifecycle.

That’s all for today’s ACT Brief. Join us next time for more updates shaping clinical operations and drug development. Thanks for listening.