Eli Lilly on Tuesday said its daily weight loss pill helped patients with obesity and Type 2 diabetes shed weight in a late-stage trial, meeting the study’s main goal and clearing the way for the company to file for approval of the drug globally. 

The treatment is inching closer to becoming a new, needle-free alternative in the highly lucrative market for weight loss and diabetes drugs called GLP-1s. More convenient pills could boost supply for the treatments and make them easier to access than the pricey weekly injections currently dominating the space. The Eli Lilly pill also would not come with dietary restrictions, in contrast to a similar oral treatment from chief rival Novo Nordisk.

Eli Lilly shares climbed more than 4% Tuesday.

The highest dose of the pill, orforglipron, helped patients lose 10.5% of their weight, or 22.9 pounds, on average at 72 weeks, compared to 2.2% weight loss among those who took a placebo. The drug’s weight loss in the study was 9.6% when analyzing all patients regardless of discontinuations.     

Eli Lilly’s pill met the trial’s other goals of helping patients lower their hemoglobin A1c, a measure of blood sugar levels. By the end of the study, most patients no longer met the criteria for Type 2 diabetes based on that metric. The rate of side effects and treatment discontinuations in the study, called ATTAIN-2, appeared to be generally consistent with two recent phase three trials on Eli Lilly’s drug.

Eli Lilly said it now has the full clinical trial data package required to file for approvals of the drug for chronic weight management with global regulators. The pharmaceutical giant expects to launch the pill around the world “this time next year,” CEO David Ricks told CNBC in early August. 

In an interview, Eli Lilly’s Chief Scientific Officer Daniel Skovronsky, said the pill had “unprecedented efficacy” in patients with obesity and Type 2 diabetes, who typically have a more difficult time losing weight compared to those without diabetes. Skovronsky said he hopes that diabetes patients will be able to use the pill earlier in their disease to slow down its progression. 

Existing GLP-1 injections have shown greater weight loss than Eli Lilly’s pill, but having an oral option that offers more than 10% for patients with both obesity and Type 2 diabetes is “actually very good, so that’s positive,” said Dr. Caroline Apovian, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital.

But she called it “concerning” that more patients – 10.6% of those on the highest dose – stopped taking the pill due to side effects compared with what has been seen in separate studies on the existing injections, Eli Lilly’s Zepbound and Novo Nordisk‘s Wegovy. Apovian said patients and their prescribers will have to weigh the risks and benefits of the pill and the injections when deciding which to take, including convenience, side effects and efficacy. 

The side effects of Eli Lilly’s pill were mainly gastrointestinal, such as nausea and vomiting, and were mild to moderate in severity. An estimated 23.1% of those who took the highest dose experienced vomiting, while 36.4% and 27.4% had nausea and diarrhea, respectively.

Around 20% of patients stopped taking the pill for any reason, which is roughly the same rate as the placebo group. Skovronsky said that reflects a combination of reasons apart from side effects. Those can include patients who wanted to stop participating in a trial because they were able to access another obesity medication, or those who didn’t lose enough weight because they were taking a lower dose of the drug.

But he said most patients stay on the drug, and said “the most important thing here is the scale of the opportunity,” referring to the number of people around the world could benefit from orforglipron. More than 100 million adults in the U.S. alone have obesity, according to Centers for Disease Control and Prevention data.

Apovian said she’s most excited about an oral option entering the market not because of how much weight loss it can promote, but rather its potential to expand access to obesity treatments, especially since a pill is much easier to manufacture than an injection. Apovian hopes Eli Lilly’s pill will be priced lower than injections — which cost roughly $1,000 per month before insurance — and receive broader insurance coverage.

Tuesday’s results are the third set of late-stage data the company has released on orforglipron this year. In April, the pill succeeded in a shorter phase three trial on diabetes patients without obesity.

Earlier this month, the drug also met the goals of a separate study on patients with obesity and not diabetes, but fell short of Wall Street’s expectations. The pill’s weight loss was higher in that trial compared to Tuesday’s data, but “that’s expected,” given the differences in patient populations, said Dr. Jaime Almandoz, medical director of the Weight Wellness Program at UT Southwestern Medical Center. 

Overall, some doctors have touted the pill’s weight loss in the trials, and some analysts say it will still be a viable competitor in the space due to factors such as its easier manufacturing and lack of dietary restrictions. 

“The convenience and specifically the lack of fasting requirements and water restrictions with orforglipron is likely one of the main differentiators when people think about other oral agents with similar effectiveness for weight change and A1C levels,” said Almandoz.

He said a pill creates additional opportunities for individualized patient care “where there’s more autonomy.”

For example, some people may be hesitant to take injections for weight loss, said Dr. Andrew Krafston, clinical associate professor at the division of metabolism, endocrinology and diabetes at the University of Michigan

“While this is a surmountable barrier for many, oral therapy aligns with traditional medication treatment and may have higher acceptability,” he said, adding that pills are less likely to be in short supply.