Research & Development

Advances in risk assessment shift the calculus of early intervention trials for MASLD

The global burden of obesity-related chronic diseases, such as MASLD, type 2 diabetes, and cardiovascular disease, continues to rise, and early intervention is seen as the most promising path, yet from the developer's perspective, it is also the narrowest and most risk-laden. Historically, early intervention trials have been difficult to conduct due to the lack of precise identification of eligible populations. However, advances in multiparameter risk prediction models are changing this landscape, making prescreening possible. Using MASLD as an example, this article analyzes how risk stratification tools, the 2026 CKM guidelines, and prescreening studies such as ALIGN enhance trial feasibility, while also cautioning that highly selective designs may pose barriers to post-marketing application.