Eli Lilly and Co. (NYSE:LLY) on Thursday announced post-hoc analyses from its ATTAIN-1 study alongside detailed Phase 3 ACHIEVE-4 trial results.
The findings demonstrate that Foundayo (orforglipron) significantly lowers predicted risks for type 2 diabetes and cardiovascular disease in overweight or obese adults.
ATTAIN-1 Analysis Highlights Long-Term Risk Reduction
Post-hoc modeling from the ATTAIN-1 study showed that Foundayo drove clinically meaningful reductions in predicted 10-year health risks across all tested dosage strengths.
At week 72, study participants taking 5.5 mg, 9 mg, and 17.2 mg doses achieved estimated diabetes risk reductions of 45.0%, 50.0%, and 57.0%, respectively, compared to placebo.
Participants receiving the 17.2 mg dose also showed an estimated 18.0% drop in predicted cardiovascular disease risk.
The trial used an investigational formulation of Foundayo at dosages equivalent to Foundayo tablets.
The ATTAIN Phase 3 global clinical development program for orforglipron enrolled more than 4,500 obese people.
ACHIEVE-4 Trial Demonstrates Superior Cardiovascular Safety
The Phase 3 ACHIEVE-4 trial—the largest and longest study of Foundayo in type 2 diabetes to date—compared the oral treatment against titrated insulin glargine in patients with type 2 diabetes and elevated cardiovascular risk.
Presented at the European Association for the Study of Diabetes meeting in Milan and published in The Lancet, Foundayo demonstrated non-inferiority by lowering major adverse cardiovascular events (MACE-4) risk by 16% and MACE-3 risk by 23%.
Pre-planned analyses showed Foundayo reduced cardiovascular mortality by 53% and all-cause mortality by 57%.
Cardiometabolic Improvements And Tolerability Profile
At week 52, Foundayo improved key cardiometabolic health markers, reducing waist circumference by 7.0 cm, systolic blood pressure by 4.4 mmHg, triglycerides by 18.9%, non-HDL cholesterol by 6.6%, and hsCRP inflammation by 38.9%.
Foundayo also slowed kidney function decline, showing a 2.8 mL/min/1.73 m² smaller eGFR reduction and a 27.1% greater albuminuria reduction versus insulin glargine.
Lilly continues evaluating Foundayo in its ongoing Phase 3 ATTAIN-OUTCOMES trial.
LLY Price Action: Eli Lilly shares were down 0.81% at $1147.75 at the time of publication on Thursday, according to Benzinga Pro data.
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