Lilly: Foundayo linked to reduced 10‑year predicted type 2 diabetes and cardiovascular risk
- Foundayo 17.2 mg was associated with an estimated 57% reduction in predicted 10‑year type 2 diabetes risk versus placebo at 72 weeks.
- Foundayo 17.2 mg was associated with an estimated 18% reduction in predicted 10‑year cardiovascular disease risk versus placebo at 72 weeks.
- ATTAIN‑1 was a 72‑week Phase 3, randomized, double‑blind, placebo‑controlled trial of 3,127 adults without diabetes; analyses were post‑hoc and published in Diabetes, Obesity and Metabolism.
- Diabetes risk was modelled with the CMDS engine and cardiovascular risk with the BMI‑based Framingham engine; change in predicted diabetes risk at 72 weeks was ~−9.8% (17.2 mg) vs −1.7% for placebo, and cardiovascular risk change was −1.0% vs +0.6% for placebo.
Key results
Post‑hoc analyses of ATTAIN‑1 showed clinically meaningful reductions in modelled 10‑year cardiometabolic risk at 72 weeks. Estimated type 2 diabetes risk reductions versus placebo were 45% (Foundayo 5.5 mg; HR 0.55, 95% CI 0.52–0.60), 50% (9 mg; HR 0.50, 95% CI 0.47–0.54) and 57% (17.2 mg; HR 0.43, 95% CI 0.40–0.47). Estimated cardiovascular disease risk reductions versus placebo were 13% (5.5 mg; HR 0.87, 95% CI 0.83–0.90), 15% (9 mg; HR 0.85, 95% CI 0.82–0.89) and 18% (17.2 mg; HR 0.82, 95% CI 0.79–0.86).
Modelling and absolute changes
Type 2 diabetes risk was estimated using the Cardiometabolic Disease Staging (CMDS) risk engine and cardiovascular risk using the BMI‑based Framingham engine. Baseline predicted 10‑year diabetes risk across arms was ~16–17%; change at 72 weeks was −8.0% (5.5 mg), −8.8% (9 mg) and −9.8% (17.2 mg) versus −1.7% for placebo. Baseline predicted 10‑year cardiovascular risk was ~8.5–8.9%; change at 72 weeks was −0.6% (5.5 mg), −0.7% (9 mg) and −1.0% (17.2 mg) versus +0.6% for placebo.
Trial context
ATTAIN‑1 (NCT05869903) was a 72‑week Phase 3 randomized, double‑blind, placebo‑controlled trial in 3,127 adults with obesity or overweight plus at least one weight‑related comorbidity who did not have diabetes. Participants were randomized to Foundayo 5.5 mg, 9 mg, 17.2 mg or placebo; active arms used an escalating titration to reach maintenance doses. Treatment was evaluated as an adjunct to exercise and a balanced, healthy diet.
Regulatory and safety notes
Foundayo (orforglipron) is FDA‑approved for chronic weight management in adults with obesity or certain adults with overweight. It is a once‑daily oral, non‑peptide GLP‑1 receptor agonist. Warnings in the U.S. label include potential thyroid tumors, pancreatitis, severe gastrointestinal adverse events, dehydration/acute kidney injury, hypoglycaemia when combined with insulin or sulfonylureas, and serious allergic reactions.
Source: Lilly