Foundayo cuts cardiovascular risks in diabetes trial as Lilly reports broader risk reductions

  • Eli Lilly reported Foundayo ACHIEVE-4 results and ATTAIN-1 post-hoc risk analyses.
  • Foundayo lowered MACE-4 risk 16% and MACE-3 risk 23% versus insulin glargine.
  • ATTAIN-1 enrolled more than 4,500 obese people across Lilly’s Phase 3 program.

Eli Lilly reported detailed Phase 3 ACHIEVE-4 results for Foundayo, orforglipron, compared with titrated insulin glargine in adults with type 2 diabetes and elevated cardiovascular risk. Foundayo demonstrated non-inferiority for major adverse cardiovascular events, with MACE-4 risk 16% lower and MACE-3 risk 23% lower than with insulin glargine. Pre-planned analyses found cardiovascular mortality 53% lower and all-cause mortality 57% lower with Foundayo. The treatment also improved A1C, weight and cardiometabolic measures, slowed kidney-function decline, and had a safety and tolerability profile generally consistent with previous trials and other incretins. Separate post-hoc ATTAIN-1 analyses found estimated 10-year diabetes-risk reductions of 45.0%, 50.0% and 57.0% at week 72 with 5.5 mg, 9 mg and 17.2 mg doses, respectively, while the 17.2 mg dose was associated with an 18.0% reduction in predicted cardiovascular disease risk. ACHIEVE-4 results were presented at the European Association for the Study of Diabetes meeting in Milan and published in The Lancet. Lilly is continuing the Phase 3 ATTAIN-OUTCOMES trial in adults with established cardiovascular or kidney disease.

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