Indianapolis, Indiana, U.S., October 1, 2026
Eli Lilly and Company has announced new post-hoc analyses from the Phase 3 ATTAIN-1 trial showing that its oral GLP-1 medicine Foundayo (orforglipron) was associated with significant reductions in predicted long-term risks of type 2 diabetes and cardiovascular disease in adults with obesity or overweight and a weight-related medical condition. The findings, published in Diabetes, Obesity and Metabolism, add to the growing clinical evidence surrounding oral GLP-1 therapies and their potential role in addressing the long-term health consequences associated with obesity. At 72 weeks, modeling showed that Foundayo was associated with estimated reductions of 45%, 50%, and 57% in predicted 10-year type 2 diabetes risk at doses of 5.5 mg, 9 mg, and 17.2 mg, respectively, compared with placebo. The highest dose was also associated with an estimated 18% reduction in predicted cardiovascular disease risk versus placebo.
Foundayo Linked to Lower Predicted Diabetes Risk
The ATTAIN-1 post-hoc analyses evaluated changes in predicted cardiometabolic risk among participants receiving three maintenance doses of Foundayo. At 72 weeks, the estimated reduction in predicted 10-year type 2 diabetes risk compared with placebo was 45% for 5.5 mg, 50% for 9 mg, and 57% for 17.2 mg. The corresponding model-based hazard ratios were 0.55, 0.50, and 0.43, respectively. Lilly said the analyses showed clinically meaningful improvements across all three Foundayo doses. These results are particularly relevant because obesity is strongly associated with the development of type 2 diabetes, making long-term metabolic risk an important consideration in obesity management. However, the findings are based on risk-prediction models rather than a direct demonstration that Foundayo prevents future diabetes events.
Cardiovascular Risk Also Declined in Analysis
The analysis also examined predicted 10-year cardiovascular disease risk using the BMI-based Framingham risk engine. At 72 weeks, Foundayo 5.5 mg, 9 mg, and 17.2 mg were associated with estimated cardiovascular risk reductions of 13%, 15%, and 18%, respectively, compared with placebo. For the 17.2 mg dose, the model estimated a hazard ratio of 0.82 with a 95% confidence interval of 0.79 to 0.86. Lilly linked these findings to improvements in several cardiovascular risk factors, including blood sugar, blood pressure, cholesterol, and body weight. The company emphasized that the analyses provide additional evidence about the potential long-term health implications of treating obesity, although predicted risk reductions should not be interpreted as proof of a reduction in actual cardiovascular events.
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Phase 3 ATTAIN-1 Supports Oral GLP-1 Development
ATTAIN-1 was a 72-week, randomized, double-blind, placebo-controlled Phase 3 trial involving 3,127 adults with obesity or overweight accompanied by at least one weight-related comorbidity, including hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease. Participants received Foundayo 5.5 mg, 9 mg, 17.2 mg, or placebo. The primary objective was to evaluate superiority over placebo for body-weight reduction after 72 weeks. The broader ATTAIN Phase 3 program enrolled more than 4,500 people with obesity or overweight across two global registration trials.
Foundayo is a once-daily oral, non-peptide GLP-1 receptor agonist. Unlike injectable GLP-1 medicines, the small-molecule therapy is designed for oral administration and can be taken at any time of day without restrictions on food or water intake. Lilly is also studying orforglipron across additional conditions, including type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease, and stress urinary incontinence. The latest ATTAIN-1 analysis further strengthens the clinical-development profile of oral GLP-1 therapy while highlighting the potential importance of obesity treatment in reducing future cardiometabolic risk.
Source: Eli Lilly press release
