Hate needles? Lilly’s weight-loss pill could get FDA approval next year, CEO says

Eli Lilly, the Fortune 500 pharma firm that manufactures weight-loss injection Zepbound (tirzepatide), has a comparable oral medication in the works that could be approved by the Food and Drug Administration as early as next year, according to CEO Dave Ricks.

“It’s highly anticipated and really important,” he told Bloomberg TV on Jan. 13 at the annual JPMorgan Healthcare Conference in San Francisco. “The benefit here is not just the convenience of the pill but the ability to scale it. We all know the production systems for injectables have really been stretched—and we continue to build sites and so forth—but with oral technology we can make more and get this medicine to more people around the world.”

The experimental pill for chronic weight management is called orforglipron—Ricks joked that even he had to practice pronouncing it—and designed to be taken once a day. By comparison, Zepbound is injected once a week. And whereas Zepbound is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist medication, orforglipron is classified as a nonpeptide GLP-1 receptor agonist drug.

Clinical trials have been promising, as indicated by Phase 2 results published in 2023 in the New England Journal of Medicine. The nearly 300 participants were adults aged 18 to 75 who were obese or overweight and had at least one weight-related condition, excluding Type 2 diabetes, and weighed an average 240 pounds. They were randomly assigned to take either a placebo or a 12-milligram, 24-milligram, 36-milligram, or 45-milligram dose of the drug for nine months.

On average, trial patients lost 8.6% to 12.6% of their body weight, or 19.8 to 29.3 pounds, after 26 weeks of taking orforglipron, compared to 2%, or 4.6 pounds, among those administered the placebo. After 36 weeks, the placebo group had lost an average of 2.3%, or 5.3 pounds, compared to 9.4% to 14.7%, or 21.6 to 34 pounds, in the orforglipron groups. About 9% of placebo patients lost at least 10% of their body weight over 36 weeks, while 47% to 75% of orforglipron patients lost at least that amount depending on their designated dosage.

“We recognize that obesity is a global epidemic and there is a need for a variety of effective medications and administration routes,” Dr. Sean Wharton, study coauthor and director of the Wharton Medical Clinic in Burlington, Ontario, said in a June 2023 news release about the trial. “These exciting results indicate that orforglipron may be an effective, once-daily oral that can be taken without food or water restrictions.”

Orforglipron has also shown favorable outcomes for adults with Type 2 diabetes. In another Phase 2 trial published in the journal The Lancet in August 2023, patients taking the pill had an average 2.1% reduction in their A1C, a measure of long-term blood sugar, after 26 weeks. By comparison, those taking a placebo or dulaglutide, the generic name for Lilly’s diabetes injection Trulicity, reduced their A1C by 0.4% and 1.1%, respectively. Mounjaro (tirzepatide), another Lilly injection for Type 2 diabetes, wasn’t part of the study.

Ricks told Bloomberg TV that data on the next round of orforglipron studies should be available by the middle of this year, presumably referring to Attain and Achieve, Lilly’s respective orforglipron Phase 3 clinical trials for chronic weight management and Type 2 diabetes.

“Is it as good as Ozempic, essentially, or semaglutide? That’s the goal for us,” Ricks said. Semaglutide is the active ingredient in Type 2 diabetes injection Ozempic and weight-loss injection Wegovy, manufactured by Fortune 500 Europe competitor Novo Nordisk. In December, Lilly announced a trial it had funded showed that over nearly 17 months, Zepbound patients lost an average 20.2% of their body weight compared to 13.7% for Wegovy patients.

Ricks dodged the question of whether orforglipron would be cheaper than Lilly’s injectables but noted, “Our goal will be to reach the masses with that product, and so we need a pricing strategy in concert with that.”

Fortune 500 pharma firms race to develop weight-loss pills

Amid the skyrocketing popularity of obesity drugs—JPMorgan Chase expects the market to exceed $100 billion by 2030—the race to develop a safe, effective oral weight-loss medication is, unsurprisingly, fierce.

Lilly’s Fortune 500 rival Pfizer, for instance, announced last summer that it was advancing development of danuglipron, its investigational oral GLP-1 receptor agonist. Pfizer completed a Phase 1 study for the drug in September and is still recruiting for another Phase 1 trial expected to run through April.

Novo Nordisk already has a semaglutide oral on the market called Rybelsus, but it’s only indicated for adults with Type 2 diabetes. That may change based on the results of a Phase 3 trial completed last year, in which patients who took 25-milligram semaglutide pills lost an average 13.6% of their body weight after 64 weeks, compared to 2.2% who took a placebo. Last year Novo Nordisk also completed a Phase 1 clinical trial for amycretin, an oral amylin (a glucoregulatory hormone) and GLP-1 receptor co-agonist.

Other companies pursuing oral weight-loss medications include Fortune 500 Europe firms AstraZeneca and Roche, as well as Viking Therapeutics and Structure Therapeutics.

For more on weight management:

• Hims & Hers Super Bowl ad slams pricey pharma industry—and fumbles FDA warnings on compounded GLP-1 drugs
• Zepbound vs. Wegovy: New clinical trial says this weight-loss medication sheds more pounds
• Most Americans who want to lose weight don’t want to take GLP-1 drugs like Wegovy and Zepbound, new survey says
• The 5 biggest weight loss myths that ‘need to die,’ according to an obesity doctor
• GLP-1 drugs like Wegovy are all the rage—but people are quitting them too fast to achieve meaningful weight loss, finds 170,000-patient study