Eli Lilly's groundbreaking oral weight loss drug trial has made new progress: effective maintenance of weight loss results after transitioning from injection to oral, and has submitted a marketing application to the FDA

Eli Lilly's investigational oral weight loss drug orforglipron has made key progress in its latest late-stage clinical trial, demonstrating its ability to effectively help patients transitioning from injections to maintain weight loss. Given the clinical potential exhibited by the drug, Eli Lilly announced on Thursday that it has submitted a New Drug Application for this once-daily GLP-1 oral medication to the U.S. Food and Drug Administration (FDA), aiming to provide a long-term weight management solution for patients with obesity without the need for injections.

The latest clinical data shows that patients switching from Eli Lilly's Zepbound or Novo Nordisk's Wegovy injection to the orforglipron oral medication were able to maintain most of their weight loss results. This outcome addresses a core pain point in the field of obesity treatment, where patients often experience significant weight rebound after stopping weekly injection treatments.

Driven by this convenience advantage, oral weight loss medications are seen as the next breakthrough in the field. The FDA granted Eli Lilly a Priority Review Voucher in November, which means the review period for the drug could be shortened to a matter of months. Although Eli Lilly's oral medication may be slightly less effective in overall weight loss compared to existing injections, its potential as a "needle-free" maintenance treatment is becoming the focus of market attention.

Currently, the global weight loss drug market is evolving into a two-horse race between Eli Lilly and Novo Nordisk. While Novo Nordisk's oral version of Wegovy is expected to launch first and seize the initiative, Eli Lilly has demonstrated the potential to capture market share of maintenance patients from competitors with orforglipron. Goldman Sachs analysts predict that by 2030, oral weight loss drugs will account for about 24% of the global $95 billion market.

Clinical Trial Validates Weight Maintenance Effect

The phase three clinical study named ATTAIN-MAINTAIN included over 300 patients with obesity. These patients had previously received 72 weeks of injection treatment with Wegovy or Zepbound in another late-stage trial and were then randomly assigned to receive either Eli Lilly's oral medication or a placebo, with continued observation for 52 weeks.

The trial results met the primary endpoint, showing that orforglipron significantly outperformed the placebo in maintaining weight after the injection treatment reached a plateau. Specifically, data shows that patients switching from Wegovy to the oral medication experienced an average weight rebound of only about 2 pounds; whereas patients switching from Zepbound averaged a rebound of about 11 pounds.

Kenneth Custer, President of Cardiovascular and Metabolic Health at Eli Lilly, stated in a statement that obesity is a chronic, progressive disease, and maintaining weight loss is still a significant challenge for many. He believes that if the drug is approved, it will provide a convenient alternative for millions of patients with obesity worldwide.

Capturing Novo Nordisk's Existing Market

Industry analysts believe that the most significant indicator of this trial is the performance of patients switching from the competing product Wegovy. BMO Capital Markets analyst Evan Seigerman noted in an October report that the positive results of this trial provide Eli Lilly with a "unique opportunity" to capture revenue share from the population that has been long-term treated with semaglutide (the active ingredient in Novo Nordisk's Wegovy and diabetes drug Ozempic) Unlike Novo Nordisk's oral medications, Eli Lilly's orforglipron is not a peptide drug. This means it is more easily absorbed by the human body and does not have the strict dietary restrictions associated with Novo Nordisk's similar products (such as Rybelsus). The characteristics of this non-peptide small molecule may offer advantages in patient compliance and long-term medication convenience.

Safety and Market Share Forecast

In terms of safety, orforglipron's overall performance is consistent with previous late-stage studies. The most common adverse reactions are gastrointestinal-related symptoms, typically mild to moderate in severity. No liver safety issues were observed in the trial.

Statistics show that the proportion of patients discontinuing treatment due to side effects remains low across different groups: 4.8% in the group switching from Wegovy and 7.2% in the group switching from Zepbound. In contrast, the discontinuation rates for both groups switching to the placebo group were 7.6% and 6.3%, respectively. Complete data from the trial is expected to be officially presented at medical conferences next year.

Goldman Sachs analysts predict that by 2030, the oral medication segment will reach approximately $22 billion. They forecast that Eli Lilly's orforglipron will capture about 60% of the oral medication market (approximately $13.6 billion), while Novo Nordisk's oral semaglutide will account for about 21% (approximately $4 billion)