Eli Lilly’s blockbuster oral weight-loss drug trial achieves new progress: After switching from injection to oral form, effective weight loss is maintained, and a marketing application has been submitted to the FDA.

Eli Lilly’s blockbuster oral weight-loss drug trial achieves new progress: After switching from injection to oral form, effective weight loss is maintained, and a marketing application has been submitted to the FDA.

Eli Lilly’s investigational oral weight-loss drug orforglipron has achieved a key milestone in its latest late-stage clinical trial, demonstrating that it can effectively help patients switching from injectables to maintain their weight-loss results. Given the drug’s clinical potential, Lilly announced Thursday that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for this once-daily GLP-1 oral medication, aiming to provide obesity patients with a long-term weight management option that does not require injections.

The latest clinical data show that patients switching from Lilly’s Zepbound or Novo Nordisk’s Wegovy injections to orforglipron oral tablets were able to maintain the vast majority of their weight loss results. This outcome addresses a core pain point in obesity treatment—patients often experience significant weight regain after stopping once-weekly injection therapy.

Driven by this convenience advantage, oral weight-loss drugs are seen as the next breakthrough in the field. In November, the FDA granted Lilly a priority review voucher, meaning the review period for the drug could be shortened to just a few months. Although Lilly’s oral drug may deliver slightly lower overall weight reduction compared to current injectables, its potential as a “needle-free” maintenance treatment option has become a market focus.

Currently, the global weight-loss drug market is evolving into a two-horse race between Lilly and Novo Nordisk. While Novo Nordisk’s oral Wegovy is expected to launch first and seize early market share, Lilly’s orforglipron demonstrates the possibility of capturing maintenance-stage patient share from its competitor. Goldman Sachs analysts predict that by 2030, oral weight-loss drugs will account for about 24% of the $95 billion global market.

Clinical Trial Validates Weight Maintenance Effect

The phase 3 study, known as ATTAIN-MAINTAIN, enrolled more than 300 obese patients. These patients had previously received 72 weeks of Wegovy or Zepbound injection therapy in another late-stage trial and were then randomly assigned to receive Lilly’s oral drug or placebo, with observation continuing for 52 weeks.

The trial met its primary endpoint: after the weight plateau phase with injectable therapy, orforglipron’s performance in maintaining weight was significantly better than placebo. Specific data show that patients switching from Wegovy to the oral drug gained back on average only about 2 pounds; those switching from Zepbound regained about 11 pounds on average.

Kenneth Custer, President of Lilly’s Cardiometabolic Health, stated that obesity is a chronic, progressive disease and maintaining weight loss remains a major challenge for many. He believes that, if approved, this drug will offer a convenient alternative for millions of obese patients worldwide.

Capturing Novo Nordisk’s Existing Market

Industry analysts believe that the most noteworthy metric of the trial is the performance of patients who switched from the competing product Wegovy. In an October report, Evan Seigerman of BMO Capital Markets noted that the positive results provide Lilly with a “unique opportunity” to extract revenue share from populations long treated with semaglutide (the active ingredient in Novo Nordisk’s Wegovy and diabetes drug Ozempic).

Unlike Novo Nordisk’s oral offering, Lilly’s orforglipron is not a peptide-based medication. This means it is more easily absorbed by the human body and, unlike Novo’s similar products (such as Rybelsus), does not carry strict dietary restrictions. The non-peptide small molecule properties may offer advantages in patient compliance and long-term medication convenience.

Safety and Market Share Forecasts

In terms of safety, orforglipron’s overall profile was consistent with previous late-stage studies. The most common adverse effects were gastrointestinal symptoms, generally mild to moderate. No liver safety issues were observed in the trial.

Statistics show that the rate of discontinuation due to side effects remained low across groups: 4.8% for those switching from Wegovy, and 7.2% for those switching from Zepbound. In comparison, the corresponding discontinuation rates for switching to placebo were 7.6% and 6.3%. Full data from the trial are expected to be formally released at a medical conference next year.

Goldman Sachs analysts predict that by 2030, the oral drug segment will reach a market size of about $22 billion. They forecast Lilly’s orforglipron will take about 60% of the oral drug market (around $13.6 billion), while Novo Nordisk’s oral semaglutide product will have about 21% share (around $4 billion).

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