The Eli Lilly & Co. logo at the company’s Digital Health Innovation Hub in Singapore, Thursday, November 14, 2024.
Huiying ore | Bloomberg | Getty Images
Elie Lilly said Thursday that its closely monitored obesity pill helped patients maintain the majority of their weight loss after switching directly from Zepbound and the company’s injection. Novo NordiskWegovy’s rival shot Wegovy during a late trial.
The company also said it has filed for Food and Drug Administration approval of the GLP-1 daily pill, called orforglipron, for obesity. The FDA said in November that it had granted a priority review voucher to the pill, which could speed up its review timeline to a few months.
Shares of Eli Lilly rose more than 2% Thursday following the announcement.
The positive trial data suggests the pill could be an effective treatment that patients can transition to if they want to preserve their weight loss but don’t want to take weekly injections long-term. Many people who stop these injections regain much of the weight they initially lost.
While Eli Lilly’s pill appears to cause less weight loss overall than existing injections, Thursday’s results highlight its potential role as a needle-free maintenance treatment in the blockbuster GLP-1 market. But an oral obesity pill from Novo Nordisk will likely enter the market first, giving the Danish pharmaceutical maker a head start in staking its claim in this area.
The phase three trial followed more than 300 obese patients who were previously taking Wegovy or Zepbound for 72 weeks in a separate late-stage study. These people were then randomized to take either Eli Lilly’s pill or a placebo for an additional 52 weeks. The oral drug achieved the trial’s primary goal of demonstrating superior maintenance of weight loss compared to a placebo in people who had previously experienced a plateau in their progress while taking the injections.
On average, patients who switched to Novo Nordisk’s Wegovy pill only regained about 2 pounds of the weight they initially lost by the end of the trial. Meanwhile, on average, people who switched to the Zepbound pill only regained about 11 pounds of the weight they initially lost by the end of the study.
This means that people in the Wegovy group maintained about 95% of their weight loss after the change, while those in the Zepbound group maintained about 80%.
“Obesity is a chronic and progressive disease, and maintaining weight loss remains a significant challenge for many,” Kenneth Custer, president of Lilly Cardiometabolic Health, said in a statement.
He said the trial showed the pill “helped people maintain the weight they worked hard to achieve” and that, if approved, it could “provide a practical alternative for the millions of people living with obesity around the world to continue their long-term health journey”.
While people in the Zepbound group appear to gain more weight back, the focus is likely more on those who left the drug’s main competitor, Wegovy.
In an October note, BMO Capital Markets analyst Evan Seigerman said positive trial results could give Eli Lilly “a unique opportunity to capture revenue share” from chronic treatment with semaglutide, the active ingredient in Novo Nordisk’s Wegovy and the Ozempic diabetes injection.
“Reducing the potential of Novo’s flagship product,” Seigerman wrote.
In a note released Thursday, David Risinger, an analyst at Leerink Partners, said the data “will contribute to commercial success and rising consensus expectations” for Eli Lilly’s pill. He said the company expects the drug to generate $2 billion in sales by the end of 2026, $9 billion by the end of 2027 and $16 billion by the end of 2028.
Dr. Caroline Apovian, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital, said the results were “still excellent” even though patients regained some of the weight they lost.
But she added: “For this to be a good change, these oral medications will have to be cheaper for insurance companies to cover than injectables, right? Obesity shots currently carry list prices of about $1,000 a month before insurance, although Eli Lilly and Novo Nordisk have reduced the prices of their direct-to-consumer drugs for patients paying cash.
It’s unclear how the companies will price their respective pills. But under recent deals with President Donald Trump, the companies said initial doses of their upcoming oral drugs, pending approvals, would cost $149 a month for anyone who gets them through the direct-to-consumer website TrumpRx. This site launches in January.
The overall safety and tolerability – or how well patients handle treatment – of the pill was consistent with previous late-stage studies. The most common side effects were gastrointestinal in origin and were generally mild to moderate in intensity.
About 4.8% of people who switched to Wegovy’s pill stopped treatment due to side effects, while 7.2% of those who switched to Zepbound’s oral medication did the same. Meanwhile, these rates were 7.6% and 6.3%, respectively, in patients who switched to a placebo from Wegovy and Zepbound.
No liver safety concerns were observed, according to Eli Lilly. Full results from the trial, called ATTAIN-MAINTAIN, will be presented at an upcoming medical meeting and published in a peer-reviewed journal next year.
Eli Lilly’s pill works similarly to the diabetes pill Rybelsus from Wegovy, Ozempic and Novo Nordisk, targeting a gut hormone called GLP-1 to suppress a person’s appetite and regulate blood sugar. Novo Nordisk is also seeking approval for an oral version of Wegovy for the treatment of obesity, which could arrive by the end of the year.
But unlike these three treatments, Eli Lilly’s pill is not a peptide drug. This means it is absorbed more easily by the body and does not require dietary restrictions like Rybelsus or Wegovy oral do.
In an August note, Goldman Sachs analysts predicted that pills will account for 24% — or about $22 billion — of the global weight-loss drug market in 2030, which they expect to be worth a total of $95 billion.
They said they expect Eli Lilly’s pill to have a 60% share – or about $13.6 billion – of the daily oral segment of the market in 2030. They expect Novo Nordisk’s oral semaglutide to have a 21% share – or about $4 billion – of that segment.