Insights
History: In April 2025, DIA convened an Executive Roundtable on Obesity Drug Development, co-chaired by Jingyu (Julia) Luan (AstraZeneca) and Maria Vassileva (DIA), bringing together regulators from FDA, experts from industry, academia, and nonprofits, and people with lived experience to identify bottlenecks in obesity drug development and explore collaboration opportunities. Initial insights were also presented at a panel during the DIA Global Annual Meeting in June 2025.

The DIA Obesity Consortium was launched in September 2025 as a public-private partnership funded by 10 companies, with DIA as neutral convener, complemented by an Advisory Committee of 15 members spanning academia, patient advocates, and FDA CDER. During this initial stage, working groups developed standardized, regulatory-grade trial data approaches, focusing on endpoints like body composition and physical function, along with weight loss durability and comorbidity trial designs.

The second Executive Roundtable in Rotterdam (March 2026) expanded engagement with EMA and European stakeholders, with proposals for data generation for body composition and physical function and discussions covering placebo strategies, combination products, and multi-indication designs.

The initial stage concluded with alignment on key scientific and regulatory priorities, and preliminary frameworks refined through FDA, EMA, industry, and academic feedback and interactions. The second stage launched in July 2026 and will advance implementation and evidence generation through work which will be ongoing through December 2027.