- Eli Lilly (LLY, Financial) reports compelling Phase 3 trial results for orforglipron, showing significant reductions in A1C by 1.3-1.6%.
- The investigational oral GLP-1 agonist achieved an average weight loss of 16.0 lbs (7.9%) at the highest dose.
- Lilly plans global regulatory submissions for weight management by the end of 2025, followed by type 2 diabetes in 2026.
Eli Lilly and Company (LLY) has announced that their oral small molecule GLP-1 receptor agonist, orforglipron, has demonstrated statistically significant efficacy in Phase 3 trials. The ACHIEVE-1 study showed substantial improvements in glycemic control for type 2 diabetes patients, with A1C reductions ranging from 1.3% to 1.6% across various doses from a baseline of 8.0%.
Participants on the highest dose of 36mg experienced an average weight loss of 16.0 lbs (7.9% body weight reduction). More than 65% of these participants achieved an A1C level of 6.5% or lower, aligning with the thresholds set by the American Diabetes Association.
Orforglipron's safety profile was consistent with existing injectable GLP-1 therapies, with common gastrointestinal side effects reported including diarrhea (19-26%), nausea (13-18%), and others. Importantly, no hepatic safety signals were identified in the study.
Lilly plans to submit orforglipron for regulatory approval for weight management by the end of 2025 and for type 2 diabetes in 2026. The company is confident in their ability to launch the medication worldwide without supply constraints, providing a potential new treatment option that could expand GLP-1 therapy access significantly.
The results of the ACHIEVE-1 trial will be presented at the upcoming American Diabetes Association Scientific Sessions and published in a peer-reviewed journal. Further results from the ACHIEVE Phase 3 clinical trial program are expected to be released later this year.
