Shares of the pharmaceutical company Lilly surged nearly 4% to reach $722 in early trading, buoyed by encouraging results from a recent clinical trial involving their new oral medication, orforglipron. This once-daily pill demonstrated significant effectiveness, helping 75% of patients who took the highest dose lower their A1C levels—a critical measure of blood sugar management—to at or below 6.5%. This figure is notably below the American Diabetes Association's recommended target of less than 7% for most adults.
Analysts have indicated that the trial data aligns with market expectations, alleviating concerns regarding orforglipron’s U.S. marketing application and its potential launch next year. Orforglipron stands out as a small-molecule pill, which simplifies manufacturing and packaging compared to the increasingly popular injectable drugs for obesity, such as Lilly's own Zepbound and Novo's Wegovy. These injectables are peptide mimics of the appetite-controlling GLP-1 hormone, making orforglipron a promising alternative.
In a comprehensive 72-week study involving over 1,600 overweight or obese adults diagnosed with type 2 diabetes, participants who received the highest 36-milligram dose of orforglipron experienced an average weight loss of 10.5%, equating to approximately 23 pounds (10.43 kg). This stood in stark contrast to the mere 2.2% weight loss observed in the placebo group, marking a significant achievement for the trial's primary goal. Those on the lowest 6 mg dose of orforglipron achieved a weight loss of 5.5%.
Kenneth Custer, president of Lilly’s cardiometabolic health division, noted that patients who are overweight and have type 2 diabetes often face greater challenges in losing weight compared to those without the condition. Armed with the data from this trial, Lilly is now prepared to initiate the approval process for orforglipron with various regulatory bodies.
When queried about the possibility of seeking a priority review voucher, which could expedite the FDA’s decision-making process for new drug applications from the standard 10 months to just six months, Custer stated that all options are being considered. The topline results from orforglipron's earlier late-stage study—conducted on overweight or obese adults without diabetes—indicated an average weight loss of 12.4%.
While analysts had anticipated orforglipron to match or even surpass Wegovy’s impressive 14.9% weight loss over 68 weeks, the recent trial results fell slightly short. The latest trial also reported that 36.4% of high-dose patients experienced nausea, and 23.1% reported vomiting, compared to 8.4% and 3.8% for the placebo group, respectively. These adverse effects were comparable to those seen in the earlier study, which contributed to a previous decline in Lilly's stock.
Despite these challenges, analysts from Truist Securities estimate that orforglipron could achieve global peak sales of up to $14.7 billion. As the market for weight-loss drugs is projected to reach $150 billion annually by the early 2030s, the demand for effective treatments remains high. The U.S. Food and Drug Administration is currently reviewing a high-dose oral version of Wegovy for potential approval this year, with Novo reporting a 15% weight loss in their own late-stage trials.
Furthermore, Lilly's latest trial results indicated that orforglipron also improved heart-risk markers, successfully lowering cholesterol, triglycerides, and blood pressure across all doses. Given that Wegovy has already been approved for reducing the risk of major heart problems, the prospect of similar heart disease approvals for orforglipron could significantly enhance its insurance coverage and market adoption.
In summary, with promising clinical trial data supporting orforglipron's efficacy for weight loss and diabetes management, Lilly is positioned to capitalize on the growing market for weight-loss medications, potentially redefining treatment options for patients struggling with obesity and type 2 diabetes.
