India Pharma Outlook Team | Saturday, 30 August 2025
Eli Lilly and Company announced positive top-line results in the Phase 3 ATTAIN-2 trial that evaluated, orforglipron, an investigational oral GLP-1 receptor agonist in adults with obesity or overweight and type 2 diabetes. The ATTAIN-2 trial showed that all three doses of orforglipron met the primary and key secondary endpoints and produced weight loss, clinically significant A1C reductions, and improvements in multiple cardiometabolic risk factors at the end of the 72-week trial period.
Participants taking orforglipron 36 mg once a day – without restrictions regarding food or water – lost an average of 10.5% (22.9 lbs), compared to only 2.2% (5.1 lbs) in the placebo group, using the efficacy estimand. Lilly is now positioned to advance the global regulatory submission process for orforglipron.
Dr. Louis J. Aronne, founder and Chair Emeritus of the American Board of Obesity Medicine, stated, "Orforglipron has the potential to deliver an efficacy, safety, and tolerability profile similar to injectable GLP-1 therapies, and this oral therapy may offer a new treatment option for patients who prefer being treated with pills while achieving similar clinical outcomes.”
Also Read: FDA Approves Teva's First GLP-1 Drug for Obesity Treatment
"The results of ATTAIN-2 confirm that orforglipron produces significant weight loss and A1C reductions that would be comparable to the landmark injectable GLP-1 trial data," said Kenneth Custer, PhD, Lilly EVP and President of Lilly Cardiometabolic Health. "With this favorable new data, we are moving quickly toward regulatory submissions, and we hope to bring a convenient, once daily oral therapy to scale throughout the world to help reshape obesity care."
If approved, orforglipron has the potential to be a groundbreaking non-injectable treatment option for patients with obesity or type 2 diabetes and help meet an important unmet need in cardiometabolic care around the world.
