Lilly’s weight-loss pill moves ahead after pivotal trial

Eli Lilly and  Co.’s experimental obesity pill helped patients lose 9.6% of their body weight in a trial that moves the company one step closer to a potential approval.

The company’s shares rose as much as 4.3% Tuesday after Lilly announced the trial results.

It’s the second of two pivotal trials that Indianapolis-based Lilly plans to use to show global health regulators that its drug, called orforglipron, is safe and effective for patients with obesity. The first trial disappointed investors earlier this month who had been expecting higher weight loss and lower rates of side effects.

Weight-loss injections from Lilly and rival Novo Nordisk A/S have revolutionized the way obesity is treated, but pills are the key to reaching more patients in the market that’s expected to grow to $95 billion by 2030. So far, however, the science has been a challenge and recent studies have fallen short of investors’ expectations.

Shares in Novo were down 3.8% on Tuesday.

Lilly’s latest trial enrolled people with obesity who also have type 2 diabetes, a patient population that typically has more difficulty losing weight. Patients given the highest dose of orforglipron lost around 21 pounds and saw significant improvements in blood sugar levels.

“This is normally where you’d expect to see some more challenges,” Kenneth Custer, president of Lilly Cardiometabolic Health, said in an interview. The data, however, is “really encouraging to us.”

Side effects in the trial were mostly gastrointestinal. About 10.6% of patients dropped out due to side effects, Lilly said. More detailed results will be presented at an upcoming medical meeting and published in a peer-reviewed journal.

With these latest data in hand, the company is on track to file for regulatory approval by the end of the year. If approved, the drug could hit pharmacy shelves sometime in 2026.

“We’re excited to get this potential medicine to patients as soon as possible,” Custer said.

Analysts have been lukewarm on orforglipron and have questioned whether Lilly can meet Wall Street’s estimates of $12 billion in annual sales by 2030. Some have even lowered their long-term forecasts.

“Oral weight-loss programs continue to be highly controversial in terms of how they are perceived by the Street,” Mizuho Securities Managing Director Jared Holz said earlier this month.

Lilly, for its part, remains confident that its drug will be a game-changer for patients living with obesity and it’s made substantial investments to meet anticipated demand at launch.

“Alongside that weight loss, we’ve seen compelling impacts on blood glucose, blood pressure, lipids, inflammatory biomarkers,” said Custer, “and you get all of that in a single pill that uses a different underlying technology.”