Lilly Announces Positive Phase 3 Results for Oral GLP-1 Receptor Agonist Orforglipron in Obesity with Type 2 Diabetes, Plans Regulatory Submission for Obesity Indication This Year

On August 26, Eli Lilly announced the positive topline results of the Phase 3 clinical trial ATTAIN-2 for its investigational GLP-1 receptor agonist orforglipron. The study targets obese or overweight adult patients with comorbid type 2 diabetes.

In the ATTAIN-2 study, all three dose groups of orforglipron met the primary endpoint and all key secondary endpoints, achieving significant weight loss, clinically meaningful reductions in glycated hemoglobin (A1C), and improvements in cardiovascular risk factors at 72 weeks. For the primary endpoint, with once-daily dosing and no restrictions on food or water intake, the orforglipron 36mg group achieved an average weight loss of 10.5% (10.4 kg), compared to 2.2% (2.3 kg) in the placebo group (using the efficacy estimand).

With the completion of the ATTAIN-2 study, Eli Lilly and Company now has all the clinical data required to submit the marketing application for orforglipron to global regulatory authorities.