Lilly's Oral Weight-Loss Drug Orforglipron Achieves 11.2% Average Weight Reduction in Phase 3 Trial, Potentially Reshaping Obesity Treatment Landscape

SmartCom APP learned that at the European Association for the Study of Diabetes conference, doctors disclosed the results of a large clinical trial of Eli Lilly and Company's (LLY.US) weight-loss drug Orforglipron tablets — the drug achieved a significant weight loss effect of 11.2% in obese adult patients, with side effects comparable to current injectable products. Eli Lilly plans to release the full data of the main obesity trial of the drug during the conference, which will also be published simultaneously in The New England Journal of Medicine.

Although in another study, Orforglipron showed slightly less weight loss efficacy compared to Eli Lilly's injectable drug Zepbound and Novo Nordisk's (NVO.US) Wegovy, doctors emphasized that its oral form will significantly expand treatment accessibility—compared to injections, tablets are easier to produce, more convenient to use, and may ultimately offer a price advantage.

"One of the lead authors of the study, Dr. Sean Wharton, Medical Director of the Wharton Medical Clinic in Toronto, noted: 'This completely transforms the approach to obesity treatment, and we can finally offer help to more patients who urgently need it.'"

Currently, the oral transformation of weight-loss injections is the core competitive direction in the obesity market. Bloomberg Industry Research predicts that this field will reach $100 billion in annual sales by 2030, with Eli Lilly and Novo Nordisk vying for the leading position.

The two companies have key differences in drug characteristics: Novo Nordisk's drug contains the same semaglutide component as in the injectable, but its production is more complex and it has more usage restrictions (such as dietary timing requirements); whereas Eli Lilly's Orforglipron belongs to what the pharmaceutical industry calls "small molecule drugs," which are more efficiently produced and have no dietary restrictions.

Despite Eli Lilly's oral drug once struggling to meet high market expectations, which led some analysts to lower sales forecasts, subsequent research data on patients with diabetes and obesity regained confidence.

Eli Lilly disclosed that the main obesity trial also showed the drug improved patients' blood pressure and cholesterol levels, with about 7% of participants in the highest dose group discontinuing the trial due to gastrointestinal side effects. Notably, a factor that may have influenced the results is that more than 35% of the participants were male, and the weight loss effect of the new generation of weight loss drugs is generally weaker in men than in women.

Stephen Lawrence, Clinical Associate Professor at the University of Warwick, reviewed the data and concluded that weight loss exceeding 10% is sufficient to produce significant clinical effects. The study included a diverse patient population, reflecting real-world medication usage scenarios. He emphasized: "The key is not how much weight is lost, but that this form is more accessible, and the ease of use of oral formulations is equally important."

Eli Lilly plans to submit a regulatory approval application by the end of the year and has applied to the FDA for accelerated review. If approved, the drug is expected to launch in 2024. The company has already stockpiled a large inventory to meet demand. CEO Dave Ricks stated, "We are communicating with the FDA and health authorities to expedite the review process."

Although Novo Nordisk may launch the oral version of Wegovy slightly earlier, its R&D progress was previously slowed down due to insufficient production capacity. In addition, Eli Lilly and Company is conducting comparative studies in patients with type 2 diabetes to evaluate the efficacy differences between its drug and the low-dose oral semaglutide medication Rybelsus.