Eli Lilly has claimed that new analyses of its once-daily oral GLP-1 drug Foundayo (orforglipron) showed substantial reductions in predicted 10-year risks of type 2 diabetes and cardiovascular disease among adults with obesity or a weight-related medical condition.

 

The findings, drawn from post-hoc analyses of the Phase 3 ATTAIN-1 trial and published in Diabetes, Obesity and Metabolism, showed the largest modeled reduction in diabetes risk among patients taking the 17.2 mg dose.

 

After 72 weeks, the analysis estimated a 57% reduction in predicted 10-year type 2 diabetes risk with Foundayo 17.2 mg compared with placebo. The corresponding modeled reductions were 45% for 5.5 mg and 50% for 9 mg.

 

The highest dose was also associated with an estimated 18% reduction in predicted 10-year cardiovascular disease risk versus placebo. The modeled reductions were 13% and 15% for the 5.5 mg and 9 mg doses, respectively.

 

The figures are based on risk-prediction models, not on the number of diabetes or cardiovascular events actually recorded during the 72-week trial.

 

"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, 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.3,4,5 That gives us real optimism about what long-term Foundayo use could mean, both for patients and for the broader healthcare system."

 

Lilly said the diabetes risk estimates were generated using the Cardiometabolic Disease Staging (CMDS) risk engine, while cardiovascular risk was estimated using the BMI-based Framingham risk engine.

 

The company said the results add to evidence around the potential long-term economic impact of treating obesity, pointing to recent research examining healthcare costs associated with obesity, cardiovascular disease and weight loss.

 

ATTAIN-1 enrolled 3,127 adults across the United States and nine other countries, including India, Brazil, China, Japan and South Korea. Participants had obesity, or overweight accompanied by at least one weight-related condition, and did not have diabetes.

 

The 72-week trial compared three Foundayo doses — 5.5 mg, 9 mg and 17.2 mg — with placebo. Participants received the drug alongside exercise and a balanced, healthy diet.

 

The study's primary objective was to determine whether Foundayo produced greater weight loss than placebo 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 GLP-1 receptor agonist. Unlike injectable GLP-1 medicines, it is a small-molecule, non-peptide drug taken by mouth.