Lose Weight on Zepbound, Keep It Off With Eli Lilly’s New Pill? Data Say That Works.

Eli Lilly has a new pill, called orforglipron, it plans to launch next year. (Scott Olson/Getty Images)

Key Points

• Eli Lilly plans to launch orforglipron, a new pill, next year, after submitting an application for FDA approval.
• Orforglipron demonstrated effectiveness as a maintenance therapy, helping patients sustain weight loss after using injectables.
• Patients switching from Wegovy to orforglipron regained 2 pounds, while those from Zepbound regained 11 pounds after one year.

Patients on the highly effective obesity treatments from Novo Nordisk and Eli Lilly face a dilemma after they lose weight on the drugs: Do you stay on the shots forever, or stop and risk gaining the weight back?

Now, it looks like Eli Lilly has a solution.

One idea, long discussed by Wall Street analysts, has been that Lilly and its peers could lock in long-term users with a pill for patients to switch to after shedding pounds on a shot like Lilly’s Zepbound or Novo Nordisk’s Wegovy.

Lilly has a new pill, called orforglipron, it plans to launch next year. On Thursday, the company reported the results of a study showing that orforglipron could work well as a maintenance therapy, helping them to keep their weight off after losing it on Wegovy or Zepbound.

The company also said Thursday that it had submitted its application for approval of orforglipron to the Food and Drug Administration. The drug has received what’s known as a Commissioner’s National Priority Voucher, a controversial new program that dramatically shortens drug approval timelines. Democratic Senators wrote in a letter last month that the review timelines under the new program are “absurdly short,” and could undermine public confidence in FDA approval decisions. Top FDA leaders have also raised concerns about the program, according to a Washington Post report.

The FDA says that reviews conducted under the new program should take “just 1-2 months,” which could mean that orforglipron would be ready for launch early in 2026.

Data on orforglipron have been largely uninspiring. Lilly shares fell 14% on Aug. seven after the company reported data showing that patients on orforglipron had lost 12.4% of their weight over 72 weeks, well short of expectations. Investors had hoped the pill would work as well as Novo’s injectable Wegovy, but the August data failed to clear that bar, raising questions about demand.

The results announced Thursday, however, lay out a new pathway for Lilly to find patients to use orforglipron. The company could sell the drug to people looking to stop taking Zepbound or Novo’s Wegovy. The new results, Leerink Partners analyst David Risinger wrote Thursday, “will help drive commercial success and upside to consensus expectations.” Lilly shares were up 2.3% on Thursday.

The trial recruited around 300 patients from among the participants in a larger study that had tested Lilly’s Zepbound against Novo’s Wegovy, and found that Zepbound worked better. After that 72-week study, patients who enrolled in the follow-up were given either orforglipron or a placebo, to test how effective orforglipron was at maintaining their weight loss.

After a year on orforglipron, patients who had been on Wegovy before switching had regained just two pounds on average, while patients who had been on Zepbound before switching had regained 11 pounds. Patients who had taken Zepbond during the earlier trial had lost significantly more weight than those on Wegovy when they started on orforglipron.

Lilly’s news release is light on details, and comparisons with the placebo group appear to be complicated by a quirk of the trial design, by which patients in the placebo group who regained half or more of their body weight were offered orforglipron.

But the company said that after 24 weeks, patients who had been on Wegovy and then a placebo pill had regained 20.7 pounds, while patients who had switched from Wegovy to orforglipron had lost another 0.2 pounds. Patients who had been on Zepbound and switched to a placebo pill had regained 20.1 pounds after 24 weeks while patients who had gone from Zepbound to orforglipon had regained just 5.7 pounds.

Orforglipron appears to have been well-tolerated in the study. Lilly said that the trial had hit all its primary and secondary endpoints.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com