ACT Brief: Designing Feasible Protocols and Breakthroughs in Obesity and Metabolic Research

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 from a new ACT interview on how real-world data can strengthen protocol design and improve trial feasibility. Matt Holms, vice president of sales at Citeline, explained that many protocols are written to be ideal in theory but unrealistic in practice—often leading to the 85% of studies that require major amendments. By incorporating real-world patient data at the earliest design stage, sponsors can ensure eligibility criteria align with findable patients across geographies, reducing protocol revisions and accelerating recruitment. Holms emphasized that using aggregated real-world and proprietary feasibility data can help avoid “unicorn” patient profiles and improve operational execution across global sites.
• Next, Novo Nordisk revealed new Phase III OASIS 4 analyses showing that oral semaglutide 25 mg not only drives meaningful weight loss but also improves key cardiometabolic markers.
  More than 70% of participants with prediabetes achieved normal blood glucose compared to one-third on placebo, and those who lost 15% or more of their body weight saw notable reductions in blood pressure and lipid levels. Novo also reported comparable weight and cardiometabolic outcomes between oral and injectable semaglutide formulations, underscoring the company’s progress toward an FDA decision on oral Wegovy expected later this year.
• Finally, Eli Lilly announced positive results from its Phase II trial of eloralintide, a once-weekly selective amylin receptor agonist showing up to 20% weight reduction in adults with obesity after 48 weeks. The results revealed clear dose-dependent efficacy with a favorable tolerability profile. The most common side effects were mild to moderate nausea and fatigue, and Lilly plans to initiate Phase III enrollment by the end of 2025. The company is also studying eloralintide alone and in combination with tirzepatide to explore potential synergy and broaden its obesity treatment pipeline.

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.