U.S. pharmaceutical company Eli Lilly announced on the 17th that its obesity treatment drug, taken once daily, has succeeded in Phase 3 clinical trials. Currently, all obesity treatment drugs are injections. Given that U.S. pharmaceutical companies Amgen and Pfizer previously halted their oral obesity drug clinical trials due to side effects, the possibility has increased that Eli Lilly will dominate the oral obesity drug market.
Eli Lilly stated that participants taking a 36 mg dose of the oral diabetes and obesity treatment 'orforglipron' in Phase 3 clinical trials lost an average of 7.3 kg over 9 months.
This Phase 3 clinical trial was conducted over 40 weeks with 559 obese patients suffering from type 2 diabetes in the U.S., China, India, Japan, and Mexico. The company noted that this Phase 3 trial met expectations regarding the safety and tolerability of the drug, blood sugar control, and weight loss. It confirms both safety and effectiveness in reducing weight and lowering blood sugar levels.
According to the announcement, blood sugar levels decreased by 1.2% to 1.5% across all dosing groups (3 mg, 12 mg, and 36 mg), and weight reduced by an average of 4.5%, 5.8%, and 7.6%, respectively. The company reported, "For some participants, blood sugar levels even dropped below the diabetes threshold." However, it noted that 8% of patients on the high dose of 36 mg experienced side effects and dropped out of the clinical trial.
Currently, the global obesity treatment market is dominated by the Danish company Novo Nordisk's Wegovy (active ingredient semaglutide) and Eli Lilly's Mounjaro (tirzepatide). Both products are GLP-1 (glucagon-like peptide-1) receptor agonist injections that slow gastric emptying to promote a sense of fullness. Injections require patients to administer a shot once a week, which can be cumbersome.
The orforglipron developed by Eli Lilly is also a GLP-1 class drug, but is characterized by being taken in pill form once a day instead of as an injection. Developing an oral obesity drug could increase patient convenience and drive demand.
Furthermore, it is easier to mass-produce than injectable treatments, which could lower drug costs. Existing injection pens for obesity treatment are more than 10 times the cost of regular syringes. David Ricks, CEO of Eli Lilly, said, "If orforglipron is approved, it will be a convenient pill taken once a day, allowing for large-scale production and global distribution."
Eli Lilly stated that it plans to submit its application for obesity drug approval this year based on the Phase 3 results of orforglipron, and intends to apply for approval as a treatment for type 2 diabetes next year. Novo Nordisk has also developed the oral GLP-1 class drug Rybelsus, which successfully passed Phase 3 trials, but has only been approved as a diabetes treatment.
The market anticipates that the oral obesity drug market will see competition between Novo Nordisk’s Rybelsus and Eli Lilly's orforglipron. Hew Hyemin, a researcher at Kiwoom Securities, stated, "I expect Rybelsus to be the competing drug for orforglipron."
On that day, Eli Lilly's stock price rose by 14% compared to the previous day in the U.S. stock market, while Novo Nordisk's stock fell by 7%. The market believes Eli Lilly has a significant chance of dominating the oral obesity drug market.
Naveed Sattar, a professor of metabolic diseases at the University of Glasgow in the U.K., commented to the Science Media Centre, "These results are very important," adding that "if a new oral medication that effectively lowers blood sugar while significantly reducing weight compared to existing diabetes treatments emerges, it will be crucial for the future of type 2 diabetes treatment." He noted, "Of course, the impact on cardiovascular disease needs to be confirmed in future clinical trials."
Eli Lilly's Phase 3 trial results for orforglipron are scheduled to be announced at the American Diabetes Association (ADA) scientific conference in June and will subsequently be published in a scientific journal.