The Eli Lilly & Company logo at the company’s Digital Health Innovation Hub facility in Singapore on Thursday, November 14, 2024.
Ole Huiin | Bloomberg | Getty Images
Eli Lilly The company’s obesity drug helped patients maintain most of their weight loss after switching from taking the company’s injectable drug Zepbound directly, the company announced Thursday. novo nordisk‘s rival shot Wegoby in a late-game trial.
The company also announced that it has applied to the Food and Drug Administration for approval of a daily GLP-1 pill called Orforglipron, an obesity drug. The FDA announced in November that it would grant the pill a priority review voucher, potentially shortening the review timeline to several months.
Positive trial data suggests the pill may be an effective treatment for transitioning patients who want to maintain weight loss but don’t want to take weekly injections for an extended period of time. Many people who stop taking these shots regain much of the weight they initially lost.
Although Eli Lilly’s pill appears to cause less overall weight loss than existing injectables, Thursday’s results highlight its potential role as a needle-free maintenance therapy in the blockbuster GLP-1 market. But Novo Nordisk’s oral obesity drug is likely to be first to market, giving the Danish drugmaker a head start as it stakes its claim in the field.
The Phase 3 study followed more than 300 obese patients who had previously taken Wegovy or Zepbound for 72 weeks in a separate late-stage study. These people were then randomly assigned to take either Eli Lilly’s pills or a placebo for an additional 52 weeks. The oral drug met the trial’s primary objective of demonstrating superior maintenance of weight loss compared to a placebo in people who had previously experienced plateaus in weight gain while receiving injections.
On average, patients who switched to Novo Nordisk’s Wegoby tablets regained only about 2 pounds of the weight they initially lost by the end of the study. On the other hand, those who switched from ZepBound to pills only gained back, on average, about 11 pounds of the weight they initially lost by the end of the study.
“Obesity is a chronic and progressive disease, and maintaining weight loss remains a major challenge for many people,” Kenneth Custer, president of Lilly Cardiometabolic Health, said in the release.
He said trials had shown the pill was “helping people maintain the weight they worked so hard to lose” and, if approved, “could provide a convenient alternative for millions of people living with obesity around the world to continue their long-term health journeys”.
People in the Zepbound group appear to have gained more weight back, but the bigger focus is likely to be people who have transitioned from Wegovy, the drug’s biggest competitor.
BMO Capital Markets analyst Evan Sagerman said in an October note that positive results from the trial could give Eli Lilly a “unique opportunity to capture revenue sharing” from Novo Nordisk’s Wegovy and chronic treatment with semaglutide, the active ingredient in the diabetes injection Ozempic.
“We’re chipping away at the potential of Novo’s flagship product,” Seigerman wrote.
The pill’s overall safety and tolerability, or how well patients cope with the treatment, was consistent with previous late-stage studies. The most common side effects were gastrointestinal and generally mild to moderate in severity.
Approximately 4.8% of those who switched from Wegovy to tablets discontinued treatment due to side effects, as did 7.2% of those who switched from Zepbound to oral medication. Meanwhile, the proportion of patients who switched to placebo for Wegovy and Zepbound was 7.6% and 6.3%, respectively.
Eli Lilly said no liver safety issues were observed. Full results from the trial, called ATTAIN-MAINTAIN, will be presented at an upcoming medical conference and published in a peer-reviewed journal next year.
Eli Lilly’s pill works similarly to Wegoby, Ozempic and Novo Nordisk’s diabetes drug Libersus, which targets a gut hormone called GLP-1 to suppress appetite and regulate blood sugar levels. Novo Nordisk is also seeking approval for an oral version of Wigoby for obesity, which could be approved by the end of the year.
But unlike these three treatments, Eli Lilly’s pill is not a peptide drug. This means it is more easily absorbed by the body and does not require dietary restrictions like Libersus or oral Wigoby.
Analysts at Goldman Sachs predicted in an August note that pills will capture a 24% share of the global weight-loss drug market in 2030, or about $22 billion, for a total market value of $95 billion.
They said they expect Eli Lilly’s tablets to have a 60% share of the daily oral segment of the market, or about $13.6 billion, in 2030. They said they expect Novo Nordisk’s oral semaglutide to have a 21% share of the segment, or about $4 billion.
