Eli Lilly’s New Obesity Pill Shows Promise for FDA Approval

Eli Lilly has reported significant progress in its quest to bring a new oral medication for obesity to market. The company announced positive results from the Phase III ATTAIN-2 trial of its experimental drug, orforglipron, which demonstrated substantial improvements in weight loss and blood sugar control among participants. The trial outcomes position Eli Lilly to seek approval from the Food and Drug Administration (FDA), with a decision anticipated in 2024.

Trial Results Highlight Weight Loss Benefits

The ATTAIN-2 trial included over 1,600 participants across ten countries, all of whom were classified as obese or overweight with type 2 diabetes. In this double-blind study, volunteers were randomly assigned to receive either a placebo or one of three varying doses of orforglipron, administered once daily. Participants remained in the study for 72 weeks, during which those taking orforglipron consistently lost more weight compared to the placebo group. Notably, those on the highest dose lost an average of approximately 10% of their baseline body weight, while the placebo group averaged a 2.5% weight loss.

The study also revealed that around one-third of participants on the highest dose achieved a weight loss of at least 15%. Importantly, orforglipron exhibited a safety profile comparable to existing GLP-1 medications, with common side effects including diarrhea and vomiting. Approximately 10% of participants on the highest dose discontinued treatment due to adverse effects, compared to 5% in the placebo group.

Competitive Landscape for Obesity Treatments

Eli Lilly’s recent findings follow the results from the earlier ATTAIN-1 trial, which focused on individuals without type 2 diabetes. This positions orforglipron as a promising candidate in the obesity treatment market, which currently features only one oral GLP-1 medication—Novo Nordisk’s Rybelsus. This drug is an oral form of semaglutide, which is also used in injections for diabetes management.

While orforglipron’s approval would mark it as the first next-generation GLP-1 pill specifically for weight loss, experts note that it may not completely overshadow its competitors. The weight loss achieved in the ATTAIN-1 trial was approximately 12.4%, which is slightly lower than the 14% average weight loss observed with Novo Nordisk’s injectable Wegovy. Furthermore, the anticipated release of a higher-dose oral semaglutide later this year could further intensify competition.

Despite these challenges, Eli Lilly’s orforglipron may appeal to many patients due to the convenience of a daily pill compared to weekly injections. The potential for easier mass production of the oral formulation could also mitigate supply chain issues that have affected injectable GLP-1 medications in recent years.

Kenneth Custer, Executive Vice President of Eli Lilly and President of Lilly Cardiometabolic Health, expressed optimism about the drug’s future. “With these positive data in hand, we are moving with urgency toward global regulatory submissions to potentially meet the needs of patients who are waiting,” he stated.

As the obesity treatment landscape evolves, orforglipron is positioned to be a significant player, but it is clear that the competition will only become more intense in the coming years.