Eli Lilly and Co. has reported significant advancements in diabetes treatment with their recent announcement concerning orforglipron, a novel oral medication aimed at managing Type 2 diabetes effectively. The company confirmed the positive results of its Phase 3 clinical trial on Thursday, highlighting the pill’s potential as an alternative to injectable therapies.

Trial Details and Results

The clinical trial evaluated the effectiveness and safety of orforglipron in adult subjects with Type 2 diabetes, comparing its performance against a placebo. The findings indicated that participants experienced an average reduction in A1C levels—key indicators in diabetes diagnosis—ranging from 1.3% to 1.6% across various dosages after a 40-week period.

In addition to improvements in blood glucose levels, participants taking the highest dose reported an average weight loss of 16 pounds. Eli Lilly noted that the participants had not reached a weight plateau by the trial’s conclusion, suggesting potential for further weight reduction.

Safety and Side Effects

Though orforglipron demonstrated promising results, some participants reported mild to moderate gastrointestinal side effects. The most common adverse effects included diarrhea, nausea, indigestion, constipation, and vomiting.

Regulatory Plans and Industry Impact

This tablet formulation represents the first successful Phase 3 trial for an oral small molecule GLP-1 drug. Eli Lilly anticipates submitting orforglipron for approval to the U.S. Food and Drug Administration (FDA) as a treatment for Type 2 diabetes in 2026, while aiming for global regulatory submissions for weight management by the end of the current year.

The company expressed confidence in its ability to launch orforglipron worldwide without supply constraints, aligning with its goal to address chronic diseases like Type 2 diabetes, projected to affect around 760 million adults by 2050.

Expert Insights

Dr. Louis Aronne, an obesity specialist and consultant for Eli Lilly, referred to orforglipron as a “transformational” drug for diabetes management. He emphasized the pill’s practicality, noting, “Just think about the idea of having a pill that can be distributed anywhere in the world, that doesn’t need to be refrigerated. It’s as effective as one of the injectable drugs we have now: Semaglutide. That is a big deal.”