Foundayo was associated with significant reductions in predicted long-term risk of type 2 diabetes and cardiovascular disease – Eli Lilly
Eli Lilly and Company announced results from post-hoc analyses of ATTAIN-1 showing that Foundayo was associated with significant reductions in predicted 10-year risk of type 2 diabetes and cardiovascular disease in adults with obesity or overweight with a weight-related medical problem.
Obesity is strongly associated with an increased risk of developing both cardiovascular disease and type 2 diabetes. Through its proven benefit in weight loss and its ability to improve certain cardiovascular risk factors like blood sugar, blood pressure and cholesterol, Foundayo may be a meaningful treatment option for the more than 100 million U.S. adults living with obesity. The findings of these analyses were published in Diabetes, Obesity and Metabolism.
“For many people living with obesity or overweight, the concern isn’t just what the scale says today, it’s whether their future could include type 2 diabetes or heart disease,” said Thomas Seck, M.D., senior vice president of product development, Lilly Cardiometabolic Health. “These additional analyses of ATTAIN-1 show that Foundayo was associated with a lower predicted long-term risk of both conditions, in addition to meaningful weight loss. We’ve also seen evidence that treating obesity and reducing the risk of its downstream consequences, like cardiovascular disease and type 2 diabetes, can meaningfully lower healthcare costs. That gives us real optimism about what long-term Foundayo use could mean, both for patients and for the broader healthcare system.”
In these analyses, modeling showed that Foundayo was associated with clinically meaningful improvements in predicted 10-year risk of type 2 diabetes and cardiovascular disease across all three doses. At 72 weeks, participants taking Foundayo 5.5 mg, 9 mg and 17.2 mg showed an estimated 45.0%, 50.0% and 57.0% reduction, respectively, in predicted type 2 diabetes risk versus placebo. Participants taking Foundayo 17.2 mg also showed an estimated 18.0% reduction in predicted cardiovascular disease risk versus placebo.
About ATTAIN-1 and the ATTAIN clinical trial program
ATTAIN-1 (NCT05869903) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Foundayo 5.5 mg, 9 mg and 17.2 mg as a monotherapy to placebo in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease, who did not have diabetes. The trial is the first Phase 3 study of this patient population in which treatment was evaluated as an adjunct to exercise and a balanced, healthy diet rather than a reduced-calorie diet. The trial randomized 3,127 participants across the U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan in a 3:3:3:4 ratio to receive either 5.5 mg, 9 mg or 17.2 mg Foundayo or placebo. The primary objective of the study was to demonstrate that Foundayo (5.5 mg, 9 mg or 17.2 mg) is superior to placebo in body weight reduction from baseline after 72 weeks in people with a BMI ≥30.0 kg/m² or a BMI ≥27.0 kg/m² with at least one weight-related comorbidity and a history of at least one self-reported unsuccessful dietary effort to lose body weight. All participants in the Foundayo treatment arms started the study at a dose of Foundayo 0.8 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 5.5 mg (via steps at 0.8 mg and 2.5 mg), 9 mg (via steps at 0.8 mg, 2.5 mg and 5.5 mg) or 17.2 mg (via steps at 0.8 mg, 2.5 mg, 5.5 mg, 9 mg and 14.5 mg). The trial was conducted using 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 people with obesity or overweight across two global registration trials (ATTAIN-1 & ATTAIN-2).
Citation: Predicting the Long-Term Risk of Type 2 Diabetes and Cardiovascular Disease With Orforglipron in People With Overweight or Obesity: A Post Hoc Analysis of the ATTAIN-1 Trial. Authors: Shraddha Shinde, Florian Kahles, Simona Vasileva-Metodiev et al. First published: 17 September 2026. Diabetes, Obesity and Metabolism. https://doi.org/10.1111/dom.71322
