Eli Lilly announced Thursday that its closely watched oral weight-loss pill helped patients maintain most of their weight reduction after switching directly from the company's injectable Zepbound or competitor Novo Nordisk's Wegovy in a late-stage clinical trial.
The company also disclosed it has submitted an application to the U.S. Food and Drug Administration (FDA) for approval of its once-daily GLP-1 class oral weight-loss drug orforglipron. The FDA granted the pill a priority review voucher in November, potentially shortening the review timeline to several months.
The positive trial data suggests the pill could serve as an effective transitional treatment option for patients seeking to sustain weight loss while avoiding long-term weekly injections. Many who discontinue injections typically regain most of their initial weight loss.
While Eli Lilly's oral therapy appears less effective overall than existing injectables, Thursday's results highlight its potential as a needle-free maintenance treatment in the blockbuster GLP-1 market. However, Novo Nordisk's oral weight-loss drug may reach the market first, giving the Danish pharmaceutical company an early advantage.
The Phase 3 trial followed over 300 obese patients who had previously completed 72 weeks of Wegovy or Zepbound treatment in another late-stage study. Participants were then randomly assigned to continue taking Eli Lilly's pill or a placebo for 52 weeks. Among patients who had reached a weight-loss plateau on injectables, the oral drug met the trial's primary goal by demonstrating significantly better weight maintenance than placebo.
On average, patients switching from Novo Nordisk's Wegovy to the pill regained only about 2 pounds of their initial weight loss by trial end. Those transitioning from Zepbound to the oral therapy regained approximately 11 pounds on average.
"Obesity is a chronic, progressive disease where maintaining weight loss remains a significant challenge for many," said Kenneth Custer, president of Eli Lilly's cardiometabolic health division, in a statement.
He noted the trial proved the pill "helps people maintain their hard-earned weight loss," and if approved, it "could provide millions of obese patients worldwide with a convenient option to continue their long-term health management journey."
While Zepbound switchers appeared to regain more weight, greater attention may focus on patients transitioning from its main competitor Wegovy.
BMO Capital Markets analyst Evan Seigerman wrote in an October report that the trial's positive results could give Eli Lilly "a unique opportunity to capture revenue share from Novo Nordisk's chronic treatment market for Wegovy and diabetes drug Ozempic's active ingredient semaglutide."
"This would gradually erode the potential of Novo Nordisk's flagship products," he added.
The pill's overall safety and tolerability profile remained consistent with previous late-stage studies. The most common side effects were gastrointestinal-related and typically mild to moderate.
About 4.8% of Wegovy switchers discontinued treatment due to side effects, compared with 7.2% of Zepbound switchers. Meanwhile, discontinuation rates were 7.6% and 6.3% respectively for patients switching to placebo from Wegovy and Zepbound.
No liver safety concerns were observed, according to Eli Lilly. Full results from the ATTAIN-MAINTAIN trial will be presented at upcoming medical conferences and published in a peer-reviewed journal next year.
Eli Lilly's pill works similarly to Wegovy, Ozempic, and Novo Nordisk's oral diabetes drug Rybelsus by targeting the gut hormone GLP-1 to suppress appetite and regulate blood sugar. Novo Nordisk is also seeking approval for an oral version of Wegovy to treat obesity, potentially gaining clearance by year-end.
Unlike these three therapies, Eli Lilly's pill isn't peptide-based, making it more easily absorbed without the dietary restrictions required for Rybelsus or oral Wegovy.
Goldman Sachs analysts predicted in an August report that oral medications will capture 24% of the global weight-loss drug market (approximately $22 billion) by 2030, with the total market expected to reach $95 billion.
They forecast Eli Lilly's pill will command 60% share ($13.6 billion) of the daily oral segment by 2030, while Novo Nordisk's oral semaglutide is projected to take 21% ($4 billion) of this segment.
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