In a direct comparison, orforglipron from Lilly outperforms oral semaglutide.
In a significant stride towards addressing global health challenges, pharmaceutical giant Eli Lilly is conducting Phase 3 studies on Orforglipron, a potential treatment for Type 2 diabetes and weight management in adults with obesity or overweight who have at least one weight-related medical problem.
Orforglipron, an investigational, once-daily small molecule oral glucagon-like peptide-1 receptor agonist, was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. The ACHIEVE Phase 3 global clinical development program for Orforglipron has enrolled over 6,000 people with Type 2 diabetes across five global registration trials.
One of these trials, ACHIEVE-3, is a 52-week, randomized, open-label study evaluating the efficacy and safety of Orforglipron compared with oral semaglutide in adults with Type 2 diabetes inadequately controlled with metformin. The primary objective of this study was to demonstrate that Orforglipron is non-inferior in A1C reduction from baseline after 52 weeks compared to oral semaglutide.
In the ACHIEVE-3 trial, the body weight for Orforglipron 12 mg vs. oral semaglutide 14 mg was a prespecified secondary endpoint and showed nominal statistical significance.
The treatment-regimen estimand represents the estimated average treatment effect regardless of adherence to study intervention or initiation of additional antihyperglycemic medications. The efficacy estimand, on the other hand, represents efficacy had all randomized participants remained on study intervention for 52 weeks without initiating additional antihyperglycemic medications.
Orforglipron is not just being studied for Type 2 diabetes. It is also being investigated as a potential treatment for obstructive sleep apnea (OSA) and hypertension in adults with obesity.
Lilly's medicines help tens of millions of people across the globe, and the company is committed to advancing new discoveries to solve some of the world's most significant health challenges. The company is motivated by making life better for millions more people and delivers innovative clinical trials that reflect the diversity of their world.
However, it's important to note that Lilly's forward-looking statements are subject to substantial risks and uncertainties in the process of drug research, development, and commercialization. There is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Orforglipron will prove to be a safe and effective treatment for Type 2 diabetes, that Orforglipron will receive regulatory approval, or that Lilly will execute its strategy as expected.
For further discussion of these and other risks and uncertainties, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Lilly works to ensure their medicines are accessible and affordable, and they undertake no duty to update forward-looking statements to reflect events after the date of this release.
All trademarks or trade names referred to in this press release are the property of the company or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners.
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