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Lilly just tightened the screws on Novo Nordisk in the obesity-and-diabetes wars. On September 29, the drugmaker released new data at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Milan showing its once-daily pill Foundayo (orforglipron) outperformed oral semaglutide in a treatment comparison.
What happened
Eli Lilly (NYSE: LLY) presented an indirect treatment comparison of Foundayo 17.2 mg against oral semaglutide 25 mg in adults with type 2 diabetes, drawing on data from the ACHIEVE-3 and PIONEER PLUS trials:
- Participants on Foundayo 17.2 mg lost 1.5% more body weight than those on oral semaglutide 25 mg at 52 weeks (95% CI: -2.7%, -0.2%).
- A1C fell 0.3 percentage points more on Foundayo 17.2 mg (95% CI: -0.6%, -0.1%).
- The analysis was covariate-adjusted for gender, age, baseline A1C and baseline weight; alternative statistical methods produced consistent results.
The findings build on the ACHIEVE-3 head-to-head study of 1,698 patients, in which Foundayo lowered A1C by 2.2% (17.2 mg) versus 1.4% with oral semaglutide 14 mg, and delivered 9.2% body-weight loss versus 5.3%.
Foundayo is a once-daily small-molecule GLP-1 pill that can be taken at any time, with or without food. It is FDA-approved for obesity in the US, and Lilly is studying it for type 2 diabetes through the five-trial ACHIEVE program.
Why it matters
This is Lilly aiming directly at Novo Nordisk’s Rybelsus franchise. Novo has applied to the FDA for approval of the 25 mg oral semaglutide dose (not currently approved in the US), and Lilly is now publishing comparison data against that exact dose. A convenient daily pill with no food restrictions could be the format that finally cracks the mass obesity market wide open — injections deter many patients, and Lilly’s data suggest no meaningful efficacy trade-off.
Be honest about the caveat: this was an indirect comparison, not a head-to-head trial against the 25 mg dose. Head-to-head trials remain the gold standard, as Lilly’s own medical team acknowledged. But for investors, the direction of travel is clear — the GLP-1 race is shifting from injections to pills, and Lilly is building the strongest dossier.
What to watch
- The FDA’s decision on Novo’s 25 mg oral semaglutide application.
- Whether Lilly seeks a US type 2 diabetes indication for orforglipron (currently approved only for obesity).
- Commercial uptake and pricing — manufacturing scale for a daily pill is a very different game than for injectables.
Sources: https://www.prnewswire.com/news-releases/lillys-foundayo-orforglipron-17-2-mg-showed-greater-weight-loss-and-a1c-reduction-than-oral-semaglutide-25-mg-among-adults-with-type-2-diabetes-in-a-new-indirect-treatment-comparison-302891494.html | https://www.morningstar.com/news/pr-newswire/20260929de57460/lillys-foundayo-orforglipron-172-mg-showed-greater-weight-loss-and-a1c-reduction-than-oral-semaglutide-25-mg-among-adults-with-type-2-diabetes-in-a-new-indirect-treatment-comparison
Related reading: Lilly’s Onswik weekly insulin win (https://bullounge.com/forums/topic/eli-lilly-wins-fda-approval-for-onswik-its-once-weekly-insulin-for-type-2-diabetes/) and the Olumiant pediatric approval (https://bullounge.com/forums/topic/fda-approves-lillys-olumiant-for-pediatric-alopecia-areata/).
Do you think a daily GLP-1 pill could take meaningful share from injections within two years — or will payer coverage and price be the real bottleneck?
Not financial advice.
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