Eli Lilly stated that results from a late-stage trial of its pill variant of GLP-1 drugs met the requirements for global regulatory approval in 2025.
The company is proactively working over injectables like Zepbound, Mounjaro and Trulicity, aiming to develop effective oral GLP-1 receptor agonists.
In May, the FDA accepted another drug manufacturer, Novo Nordisk’s application for an oral form of Wegovy, with a decision expected by the end of this year.
Currently, Novo’s Rybelsus is the only GLP-1 drug accessible for type 2 diabetes; however, it needs stricter diet restrictions to follow.
Lilly’s pill, orforglipron, does not. Pills are considered as a more convenient option in contrast to the injections that require refrigeration, available at a higher cost.
In the latest trial, with the highest dose of the pill, orforglipron, patients lost 10.5% of their weight, or 22.9 pounds over 72 weeks, in contrast to 2.2% weight loss among those who received a placebo.
It is pertinent to mention that the drug significantly reduced A1C by 1.8%.
Adverse effects were reportedly similar to injectable GLP-1s, with stomach upset the most common and generally mild to moderate.
In the study, the drug’s weight loss was 9.6% when assessing all patients regardless of discontinuations.
Lilly stated that it now has complete clinical data required for global submissions and has already started its production in bulk quantity.
Results will be published in a peer-reviewed journal. Moreover, Eli Lily started experimenting with the pill for conditions, including increased blood pressure and sleep apnea.
