Oral GLP-1 drug linked to weight loss in patients with and without diabetes—is FDA approval next?
Eli Lilly and Company is back with even more new positive data on orforglipron, the company’s oral GLP-1 receptor agonist.
Just weeks ago, the company shared results from the ATTAIN-1 trial that linked orforglipron to an average weight loss of 12.4%, or 27.3 pounds, in obese or overweight patients without diabetes. Now, the company has shared initial results from the ATTAIN-2 trial, an in-depth analysis of the drug’s impact on obese or overweight patients with type 2 diabetes.
Overall, all three doses of orforglipron—6 mg, 12 mg and 36 mg—were associated with significant weight loss, A1C reductions and consistent improvements in cardiometabolic risk factors after 72 weeks. Patients given the 36-mg dose experienced an average weight loss of 10.5%, or 22.9 pounds, and A1C reductions of 1.8%.
“Based on my experience leading clinical trials in obesity and diabetes, these data show the potential for orforglipron to offer an efficacy, safety and tolerability profile consistent with the injectable GLP-1 class,” Louis J. Aronne, MD, a longtime obesity specialist and founder and chair emeritus of the American Board of Obesity Medicine, said in a statement. “Orforglipron could help health care providers expand treatment options for patients who prefer oral therapies without compromising clinical results.”
“The ATTAIN-2 results reinforce the potential for orforglipron, as a once-daily oral, to deliver meaningful weight loss and A1C reduction, consistent with similar landmark trials for injectable GLP-1s,” added Kenneth Custer, PhD, a Lilly executive vice president and president of Lilly Cardiometabolic Health. “With these positive data in hand, we are moving with urgency toward global regulatory submissions to potentially meet the needs of patients who are waiting. If approved, we are ready to offer a convenient, once-daily pill that can be scaled globally—removing barriers and redefining how obesity is treated around the world.”
Nausea, vomiting, diarrhea, constipation and dyspepsia were the most common adverse events for patients treated with orforglipron.
Full ATTAIN-2 results are expected to be published in a peer-reviewed medical journal in the months ahead.
GLP-1 drugs taking the industry by storm
These latest findings represent just the latest round of encouraging data on weight loss drugs that can also improve a patient’s cardiovascular health. Tirzepatide and semaglutide, for example, are two popular diabetes drugs being used more and more for weight loss and other conditions.
Tirzepatide is a popular dual GIP/GLP-1 receptor agonist sold by Lilly under the brand names Zepbound and Mounjaro. It has previously been linked to improved outcomes in patients with sleep apnea and heart failure with preserved ejection fraction.
Semaglutide, meanwhile, is a GLP-1 receptor agonist sold by Novo Nordisk under the brand names Wegovy and Ozempic. It has been associated with a long list of health benefits, including several associated with improvements in cardiovascular symptoms in patients with and without diabetes.
And at ACC.25, the annual meeting of the American College of Cardiology, the oral version of semaglutide was associated with significant cardiovascular benefits for patients with type 2 diabetes, highlighting the potential of these alternative treatments that can provide relief for patients uncomfortable with injections.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.