On the third day of EASD 2025, four key news items were observed from Lilly, FDA, and Regeneron Pharmaceuticals. Below, FENIX provides context and analysis for the announcements, including thoughts on how orforglipron could potentially be approved as early as YE 2025.
Lilly announced topline results from the Ph3 ATTAIN-2 study evaluating orforglipron (QD oral GLP-1RA) in patients with obesity or overweight with T2DM, demonstrating mean body reductions of up to -10.5% after 72 weeks of treatment (view CT.gov record). Recall, earlier this month, Lilly shared topline results from the Ph3 ATTAIN-1 study, which evaluated orforglipron in non-T2DM participants with overweight or obesity (previous FENIX insight). Of note, Lilly’s stock is up ~5% today following the readout. Below, FENIX provides highlights and insights from the ATTAIN-2 topline results.
Lilly hosted its Q2 ‘25 earnings call (press release; slides) and provided updates across its CVRM portfolio. Separately, Lilly announced topline results from its Ph3 ATTAIN-1 trial evaluating orforglipron in 3,127 non-T2DM obese adults (view press release; CT.gov record). Of note, Lilly’s stock is down -15% due to the lower-than-expected ATTAIN-1 weight loss, despite raising revenue guidance. Below, FENIX provides highlights and insights from the call and data readout.