Eli Lilly reports successful Phase 3 trial for its new diabetes pill

Key Takeaways

• Orforglipron becomes first oral GLP-1 receptor agonist to complete Phase 3 trial: Eli Lillys once-daily pill achieved significant reductions in blood sugar and weight in type 2 diabetes patients with no food or water restrictions required.

• Promising efficacy and tolerability results: The ACHIEVE-1 trial showed A1C reductions of up to 1.6% and weight loss of up to 15.8 pounds, with a safety profile consistent with other GLP-1 class medications.

• Global launch plans in motion: Lilly plans to submit orforglipron for weight management approval by end of 2025, followed by diabetes treatment in 2026, and claims no anticipated supply constraints.

Eli Lilly has announced that its investigational oral diabetes medication, orforglipron, has successfully met primary and key secondary endpoints in its Phase 3 ACHIEVE-1 clinical trial, marking a significant step forward in the treatment of type 2 diabetes.

While competing GLP-1 drugs to treat type 2 diabetes have been wildly popular, they are all administered by injection. Orforglipron is the first oral small molecule GLP-1 receptor agonist to complete a Phase 3 trial, offering a convenient once-daily treatment for people with type 2 diabetes who have inadequate glycemic control through diet and exercise alone.

Unlike existing GLP-1 injectable medications, Eli Lilly said orforglipron can be taken without food or water restrictions, potentially improving adherence and quality of life.

Strong efficacy in blood sugar and weight control

The trial demonstrated that orforglipron achieved reductions in A1Ca key marker of blood sugar controlcompared to placebo over 40 weeks. Reductions ranged from 1.2% to 1.5%, versus 0.4% with placebo, bringing participants down from a baseline A1C of 8.0%. Over 65% of patients on the highest dose achieved an A1C of 6.5% or lower, the threshold recommended by the American Diabetes Association.

The study also revealed significant weight loss among participants, with the highest dose group averaging a 7.6% body weight reduction, or 15.8 pounds, compared to just 3.4 pounds in the placebo group. Importantly, weight loss appeared ongoing at the conclusion of the trial, suggesting the full therapeutic potential may not yet have been reached.

Lilly said it intends to submit orforglipron for regulatory approval in weight management by the end of 2025, followed by a submission for type 2 diabetes treatment in 2026. Additional data from both the ACHIEVE and ATTAIN Phase 3 programs will be released later this year, with full results scheduled for presentation at the 85th American Diabetes Association Scientific Sessions and publication in a peer-reviewed journal.

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