Foundayo linked to lower predicted long term diabetes and cardiovascular risk in ATTAIN 1 analysis

Eli Lilly has reported new post hoc analyses from the Phase III ATTAIN 1 study suggesting that its oral GLP 1 treatment Foundayo, also known as orforglipron, may lower the predicted long term risk of developing type 2 diabetes and cardiovascular disease in adults living with obesity or overweight and a related medical condition.

The analyses assessed estimated 10 year cardiometabolic risk after 72 weeks of treatment across three doses of Foundayo.

At the highest evaluated dose of 17.2 mg, treatment was associated with an estimated 57% reduction in predicted type 2 diabetes risk compared with placebo.

The same dose was also linked to an estimated 18% reduction in predicted cardiovascular disease risk versus placebo.

Lilly said the findings add to evidence showing that weight loss and improvements in cardiometabolic risk factors may have broader implications beyond reductions in body weight alone.

Thomas Seck, MD, Senior Vice President of Product Development at Lilly Cardiometabolic Health, said people living with obesity or overweight often face concerns about future conditions such as type 2 diabetes and cardiovascular disease.

He said the latest analysis suggests that Foundayo may lower the estimated long term risk of both conditions alongside its previously demonstrated effects on weight.

The post hoc analysis used modelling tools to estimate disease risk rather than directly measuring whether participants developed type 2 diabetes or cardiovascular events.

Predicted type 2 diabetes risk was assessed using the Cardiometabolic Disease Staging risk engine, while cardiovascular disease risk was estimated using the body mass index based Framingham risk model.

At baseline, predicted 10 year type 2 diabetes risk ranged from 16.0% to 17.3% across the treatment groups.

After 72 weeks, predicted risk fell by 8.0 percentage points with Foundayo 5.5 mg, 8.8 percentage points with the 9 mg dose and 9.8 percentage points with 17.2 mg.

The placebo group experienced a reduction of 1.7 percentage points.

Compared with placebo, the estimated relative reductions in predicted type 2 diabetes risk were 45% with Foundayo 5.5 mg, 50% with the 9 mg dose and 57% with the 17.2 mg dose.

For cardiovascular disease, baseline predicted 10 year risk ranged from 8.5% to 8.9%.

At week 72, predicted cardiovascular risk declined by 0.6 percentage points with Foundayo 5.5 mg, 0.7 percentage points with 9 mg and 1.0 percentage point with the 17.2 mg dose.

By comparison, predicted risk increased by 0.6 percentage points in the placebo group.

The corresponding estimated cardiovascular disease risk reductions versus placebo were 13%, 15% and 18% across the 5.5 mg, 9 mg and 17.2 mg doses respectively.

The findings were published in Diabetes, Obesity and Metabolism.

Lilly said Foundayo’s effects on weight, blood glucose, blood pressure and cholesterol may contribute to improvements in estimated long term cardiometabolic risk.

The company also pointed to previous research suggesting that reducing obesity and related complications could lower longer term healthcare spending for patients and health systems.

Foundayo is an oral GLP 1 receptor agonist being developed as a treatment for obesity and related metabolic conditions.

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