Lilly recently shared the topline results from its clinical trial. The trial was designed to determine the efficacy of orforglipron, an oral medication from the glucagon-like peptide 1 (GLP-1) agonist class, in treating type 2 diabetes. The trial tested the new drug in 559 adults who could not adequately manage their blood sugar levels through diet and exercise alone. This is an exciting new step forward in the management of diabetes. The results show, for the first time, that orforglipron can be a realistic and effective replacement to injections like Ozempic.
Participants in the trial had an average starting hemoglobin A1C of 8%. After 40 weeks of treatment, participants taking orforglipron saw substantial reductions in their A1C levels by an average of 1.3% to 1.6%. By contrast, the placebo group saw virtually no change, just a 0.1% decrease. What’s even more impressive than the billboard buy is all of that results, which are indeed by the numbers. They represent a new frontier in diabetes management, particularly for patients who favor oral medications over injections.
Lilly is looking forward to sharing these findings at the American Diabetes Association’s 85th Scientific Sessions. For all their excitement, the findings still remain to be published in a peer-reviewed scientific journal. Researchers aren’t just looking at or forglipron for diabetes. They too are testing its efficacy among adults over 18 years old with a BMI of ≥ 25 or ≥ 30 who have at least one weight-related medical complication.
The trial’s high-dose group showed an average weight loss of 16 pounds (7.3 kilograms) after 68 weeks. Furthermore, two-thirds of the participants on this higher dosage saw a more than 1% decrease in their A1C levels. They got to 6.5% or less, the standard threshold often used to define diabetes.
Dr. Daniel Skovronsky, the chief scientific officer of Lilly, spoke enthusiastically about the trial. He focused particular attention on the need for alternatives to diabetes injections and the need to make them more widely available.
“Injections cannot be the solution for billions of people around the world,” – Dr. Daniel Skovronsky, chief scientific officer of Lilly.
At least on the surface, orforglipron’s safety profile appears more favorable. The most frequent side effects were mild to moderate in severity, and consistent with other GLP-1 agonists. First, Lilly is preparing to file for Food and Drug Administration (FDA) approval later this year. They plan to focus on marketing orforglipron exclusively for treating obesity. They intend to go for regulatory approval from the FDA for its incorporation into diabetes management by early 2026.
Lilly’s announcement about the trial noted that study subjects had not achieved a weight “plateau” by the end of the study. This implies they might not have realized the complete potential for weight reduction already.
“Given that participants had not yet reached a weight plateau at the time the study ended, it appears that full weight reduction was not yet attained,” – Lilly statement.
We all know the pharmaceutical landscape is changing quickly. Orforglipron’s recent development injects significant potential into patients’ tools for combating diabetes and weight complications that come with the disease. The potential approval and subsequent availability of this oral medication may represent a significant advancement in the treatment protocols for individuals battling type 2 diabetes.
