Eli Lilly has said that its once-daily oral drug Foundayo (orforglipron) 17.2 mg was associated with greater weight loss and improved blood-sugar control than oral semaglutide 25 mg in adults with type 2 diabetes, according to a new indirect treatment comparison.

 

The analysis found that patients taking Foundayo lost 1.5% more body weight and achieved a 0.3 percentage-point greater reduction in A1C after 52 weeks compared with those taking oral semaglutide 25 mg.

 

The findings, presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes in Milan, build on results from Lilly’s ACHIEVE-3 head-to-head trial, which compared Foundayo with lower doses of oral semaglutide.

 

"For someone managing type 2 diabetes, the choice between treatments is a decision that impacts their life every day," said Deborah Horn, director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston. "Having data to help us compare available medications provides clinicians the opportunity to make informed treatment choices that fit each patient's needs."

 

The latest analysis drew on data from Lilly’s ACHIEVE-3 trial and the PIONEER PLUS study of oral semaglutide. Lilly said the comparison was adjusted for gender, age, baseline A1C and baseline weight.

 

At 52 weeks, participants taking Foundayo 17.2 mg lost an average of 1.5% more body weight than those taking oral semaglutide 25 mg. Foundayo also reduced A1C by 0.3 percentage points more.

 

Lilly said alternative statistical methods produced similar results, with Foundayo showing 1.5% to 2.4% greater weight loss and 0.3 to 0.6 percentage points greater A1C reduction compared with oral semaglutide 25 mg.

 

The company cautioned that the comparison is indirect rather than a head-to-head trial.

 

"Head-to-head trials ultimately provide the best comparison of two medicines, but when we don't yet have those data, then other approaches can provide informative data points," said Rachel Batterham, senior vice president of medical innovation and external engagement, Lilly Cardiometabolic Health. 

 

"Results from this indirect treatment comparison suggest that Foundayo may deliver A1C and weight lowering that is similar to the 25 mg dose of oral semaglutide. These results, paired with simple administration free of fasting or water restrictions, are what make Foundayo a potentially foundational therapy for adults managing type 2 diabetes around the world."

 

Lilly’s ACHIEVE-3 Phase 3 trial directly compared Foundayo with oral semaglutide in 1,698 adults with type 2 diabetes whose disease was inadequately controlled with metformin.

 

At 52 weeks, Foundayo reduced A1C by an average of 1.9% with the 9 mg dose and 2.2% with the 17.2 mg dose, compared with 1.1% with oral semaglutide 7 mg and 1.4% with oral semaglutide 14 mg, according to Lilly.

 

The trial also showed greater average weight loss with Foundayo. Patients receiving 9 mg lost 14.6 pounds, or 6.7%, while those receiving 17.2 mg lost 19.7 pounds, or 9.2%. Patients taking oral semaglutide lost 7.9 pounds, or 3.7%, at 7 mg and 11.0 pounds, or 5.3%, at 14 mg.

 

The ACHIEVE Phase 3 program enrolled more than 6,000 people with type 2 diabetes across five global registration trials.

 

The 25 mg once-daily dose of oral semaglutide is not approved in the United States for type 2 diabetes. According to Lilly, Novo Nordisk has submitted an application to the U.S. Food and Drug Administration seeking approval of that dose.

 

Foundayo is FDA-approved for adults with obesity, or certain adults with overweight and weight-related medical conditions, to reduce excess body weight and maintain weight reduction alongside a reduced-calorie diet and increased physical activity.

 

The drug is a once-daily oral GLP-1 receptor agonist that can be taken without restrictions on food or water intake. Lilly is also studying orforglipron as a potential treatment for type 2 diabetes and several other conditions.

 

The latest findings do not establish a direct clinical comparison between Foundayo 17.2 mg and oral semaglutide 25 mg because they come from an indirect treatment comparison based on separate clinical trials.

 

Lilly said Foundayo is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.