Eli Lilly and Company (NYSE:LLY) reported results from an indirect treatment comparison in which Foundayo, or orforglipron, 17.2 mg was associated with greater reductions in body weight and blood sugar than oral semaglutide 25 mg in adults with type 2 diabetes over 52 weeks.
The analysis was presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes in Milan, Italy, and used data from the ACHIEVE-3 and PIONEER PLUS clinical trials.
Because the findings are based on an indirect comparison rather than a head-to-head trial of the two doses, they do not represent results from patients randomised directly between orforglipron 17.2 mg and oral semaglutide 25 mg.
Analysis Shows Differences in Weight and A1C
In the analysis, patients receiving Foundayo 17.2 mg had an average 1.5 percentage points greater reduction in body weight than those receiving oral semaglutide 25 mg. The 95% confidence interval was -2.7% to -0.2%.
Foundayo was also associated with a 0.3 percentage-point greater reduction in haemoglobin A1C, with a 95% confidence interval of -0.6% to -0.1%.
The analysis was adjusted for gender, age, baseline A1C and baseline body weight.
Using different statistical methods, Lilly reported that Foundayo 17.2 mg was associated with 1.5 to 2.4 percentage points greater weight loss and a 0.3 to 0.6 percentage-point greater reduction in A1C compared with oral semaglutide 25 mg.
Lilly noted that the 25 mg dose of oral semaglutide is not currently approved in the US for type 2 diabetes. Novo Nordisk has submitted an application to the US Food and Drug Administration seeking approval for that dose.
ACHIEVE-3 Provided Head-to-Head Comparison at Lower Doses
The latest analysis follows results from the ACHIEVE-3 head-to-head trial, which directly compared Foundayo doses of 9 mg and 17.2 mg with oral semaglutide doses of 7 mg and 14 mg.
In that trial, Foundayo 17.2 mg reduced A1C by 2.2% and resulted in average weight loss of 19.7 pounds.
Patients receiving oral semaglutide 14 mg recorded an A1C reduction of 1.4% and average weight loss of 11.0 pounds, according to the supplied results.
The direct comparison therefore involved a lower semaglutide dose than the 25 mg dose evaluated through the indirect analysis.
Orforglipron Under Study for Type 2 Diabetes
Foundayo is approved by the FDA for weight management in adults with obesity or adults who are overweight and have weight-related conditions.
The drug is also being studied as a potential treatment for type 2 diabetes and other indications.
Orforglipron was originally discovered by Chugai Pharmaceutical and licensed to Lilly in 2018.
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