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Shares of Eli Lilly (LLY) jumped on Thursday morning after the company announced topline Phase 3 results from ACHIEVE-1, evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Commenting on the news, Leerink said that the once-daily oral GLP-1 pill showed similar efficacy and safety relative to weekly injectable semaglutide, made by Novo Nordisk (NVO).
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PRIMARY ENDPOINT MET: Eli Lilly announced topline Phase 3 results from ACHIEVE-1, evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Orforglipron is the first oral small molecule glucagon-like peptide-1 receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial. If approved, the company is confident in its ability to launch orforglipron worldwide without supply constraints. This would further Lilly’s mission to reduce chronic diseases like type 2 diabetes, which is expected to impact an estimated 760 million adults by 2050.
In the first Phase 3 trial of the ACHIEVE program, orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by an average of 1.3% to 1.6% from a baseline of 8%, using the efficacy estimand. In a key secondary endpoint, more than 65% of participants taking the highest dose of orforglipron achieved an A1C less than or equal to 6.5%, which is below the American Diabetes Association’s defined threshold for diabetes. In an additional key secondary endpoint, participants taking orforglipron lost an average of 16.0 lbs at the highest dose. 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.
The overall safety profile of orforglipron in ACHIEVE-1 was consistent with the established GLP-1 class. Overall treatment discontinuation rates due to adverse events were 6%, 4% and 8% for orforglipron vs. 1% with placebo. No hepatic safety signal was observed. Lilly expects to submit orforglipron for weight management to global regulatory agencies by the end of this year, with the submission for the treatment of type 2 diabetes anticipated in 2026.