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Eli Lilly's New Oral Weight Loss Drug Clears Cardiovascular Bar - Eli Lilly (NYSE:LLY)
The trial enrolled more than 2,700 adults and found a 16% lower risk of major cardiovascular events, while Lilly plans a diabetes filing by quarter-end.
- On Thursday, Eli Lilly and Company announced positive results from the ACHIEVE-4 trial, showing Foundayo reduced the risk of major adverse cardiovascular events by 16% compared to insulin glargine in adults with type 2 diabetes.
- The trial results directly address FDA concerns regarding potential liver injury, as the study found no hepatic safety signals consistent with earlier ACHIEVE and ATTAIN program findings.
- Foundayo demonstrated superior improvements in A1C levels and body weight at 52 weeks, while patients experienced a 57% lower risk of all-cause death versus the insulin glargine group.
- Eli Lilly and Company plans to submit Foundayo for type 2 diabetes approval by the end of the second quarter, utilizing the National Priority Review Voucher to accelerate market entry.
- Competition with Danish rival Novo Nordisk intensifies as its oral Wegovy has been available since January, with both firms racing to capture the growing oral GLP-1 diabetes market.
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ACHIEVE-4, the longest Phase 3 study of Lilly's Foundayo (orforglipron) to date, reaffirmed its cardiovascular and overall safety profile as well as consistent improvements across key measures of cardiometabolic health
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 ACHIEVE-4 trial evaluating the efficacy and safety...
·United States
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Eli Lilly (LLY) Stock Climbs on Foundayo Trial Results Showing 57% Reduction in Death Risk
Key Takeaways Foundayo demonstrated a 16% reduction in major cardiovascular events including heart attack, stroke, and cardiovascular death versus insulin glargine. All-cause mortality decreased by 57% among patients taking Eli Lilly’s obesity medication in the comprehensive trial. The study enrolled 2,700 adults with type 2 diabetes, obesity, and heightened cardiovascular risk factors. Eli Lilly expects to submit an FDA application for Founday…
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