Novo Nordisk Just Beat Lilly in a Trial. Is the Comeback Finally Taking Shape?

Novo Nordisk (NYSE:NVO) finally has a CagriSema result it can put next to Eli Lilly’s (NYSE:LLY) tirzepatide and come out ahead. In the Phase 3 REIMAGINE 5 trial, adults with type 2 diabetes taking the 1 mg/ 1 mg dose of CagriSema lost an estimated 12.4% of their body weight after 60 weeks, compared with 9.1% for patients receiving 5 mg of tirzepatide, which is the active ingredient in Lilly’s Mounjaro and Zepbound. CagriSema also delivered non-inferior blood-sugar reduction.

For Novo investors, the timing holds significance since CagriSema is one of the company’s most important next-generation obesity assets, and the FDA is expected to decide on its weight-management application in the fourth quarter, with the company targeting a launch early next year.

Bull Case

The latest results give Novo another positive data point for one of its key next-generation obesity candidates. The 12.4% weight-loss result was statistically superior to the 9.1% achieved with tirzepatide 5 mg, and the company also reported that CagriSema reduced HbA1c by 1.71%, compared with 1.67% for tirzepatide, which met the trial’s non-inferiority objective for blood-sugar reduction.

That is not the only encouraging CagriSema data Novo released, as in the separate Phase 3 REDEFINE 9 study, the same 1 mg/1 mg dose produced estimated weight loss of 21% after 68 weeks in adults with overweight or obesity, compared with 2.0% for placebo. The drug combines cagrilintide, a long-acting amylin receptor agonist, with semaglutide, the GLP-1 ingredient in Wegovy.

This is important for investors to pay attention to as Novo prepares for the next stage of its obesity franchise. The company submitted CagriSema to the FDA for weight management in December 2025, and a regulatory decision is expected in the fourth quarter of 2026. Reuters also reported that Novo is targeting an early-2027 launch.

Bear Case

There is one major reason investors shouldn’t read the headline and conclude that CagriSema has now established itself as a better weight-loss drug than Zepbound. This trial compared CagriSema 1 mg/1 mg with tirzepatide 5 mg. Tirzepatide is available at higher doses, and the result follows a much less favorable head-to-head study for Novo earlier this year.

In February, CagriSema fell short against Lilly’s Zepbound in a separate obesity trial. That result follows the February REDEFINE 4 trial, in which CagriSema 2.4 mg/2.4 mg failed to demonstrate non-inferiority to tirzepatide 15 mg for weight loss in adults with obesity. BMO analyst Evan Seigerman therefore described the latest low-dose data as encouraging but less impactful in light of that earlier result.

The market’s initial reaction also suggests investors are looking well beyond a single clinical win. The positive CagriSema data was not enough to lift investor sentiment on Monday, as Novo shares fell while analysts questioned the company’s pricing assumptions and strategy ahead of semaglutide patent expirations. CagriSema consequently carries a lot of strategic importance, with Reuters describing it as a potential successor to Wegovy, whose patents begin expiring after 2030, while Novo is trying to recover ground lost to Lilly in the rapidly growing obesity market.

Conclusion

The latest data make the CagriSema story more interesting, but they don’t settle Novo’s (NYSE:NVO) competition with Lilly. While beating a 5 mg tirzepatide is a positive result, it is not the same as proving superiority to Zepbound across its dosing range.

For Novo investors, the bigger question is whether CagriSema can become a strong enough commercial successor to extend the company’s obesity franchise as competition intensifies and Wegovy moves closer to eventual patent expirations. With an FDA decision expected in the fourth quarter and Novo targeting a launch early next year, investors should soon get a much clearer answer.

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This article is originally published at Insider Monkey.