Lilly has its Ozempic-beating data from a head-to-head diabetes trial. Should Novo Nordisk be worried?

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Eli Lilly's dual GIP/GLP-1 candidate tirzepatide has topped Novo Nordisk's Ozempic in a head-to-head clinical trial, but analysts believe the difference runs short to completely transform the diabetes market. (Pixabay)

Eli Lilly has posted several sets of pivotal trial data portraying its dual-action drug candidate tirzepatide as a potentially better diabetes option than Novo Nordisk’s Ozempic. But those cross-trial comparisons made the argument less compelling, and industry watchers had been holding out for results from a head-to-head study.

This week, the conclusion from the phase 3 Surpass-2 trial was clear: In terms of reducing blood sugar levels and body weight, Lilly’s dual GIP/GLP-1 agonist, at all three doses tested, was better than Novo’s GLP-1 drug at its highest approved dose.

Now that tirzepatide has directly trumped Ozempic, does it mean the diabetes market is set for a major shakeup? Not necessarily, analysts said.

As Bernstein analyst Ronny Gal sees it, 5 mg tirzepatide and 1 mg Ozempic are the “work-horse” doses of the drugs. At those doses, tirzepatide achieved a reduction of A1C—a measurement of blood sugar—of 2.09% and a weight loss of 7.8 kg (17 lbs). In contrast, Ozempic posted a drop of 1.86% in A1C and 6.2 kg (14 lbs) in body weight.

The difference was “not jaw-dropping,” Gal wrote in a Thursday note to clients, though he acknowledged that 5 mg tirzepatide now sets “a bit better efficacy/side-effect benefit” for the base regimen. Another analyst at Bernstein, Wimal Kapadia, also said the difference between the two drugs was “a little smaller” than he had anticipated.

RELATED: Lilly's tirzepatide beats Novo's semaglutide in diabetes phase 3, but another study muddies picture

The size of tirzepatide’s benefit over Novo’s entrenched Ozempic could make all the difference. “I still question usage of a dual agonist if efficacy is only slightly better,” Kapadia said in an email. In his investor note, Gal said tirzepatide’s edge is “likely not sufficient to drive the transformation of the GLP-1 market.” 

The Surpass-2 study didn’t test Ozempic at the 2 mg once-weekly dosing, which Novo recently filed for U.S. approval. Gal has previously predicted that the majority of patients will stick to the lower doses of Ozempic and tirzepatide due to the increased side effects linked to the higher doses. Only a small proportion of patients who didn’t achieve their treatment goals will opt for the stronger drug, he's said. For the higher 10 mg and 15 mg doses of tirzepatide, Gal predicts around 20% to 30% of patients total will reach those doses.

In a statement Thursday, Novo pointed to Ozempic’s various doses as well as its sister oral med Rybelsus as ways to “help meet the individualized needs of millions of people living with Type 2 diabetes based on where they are in their disease progression.”

RELATED: Watch out, Novo Nordisk. Lilly's new dual action diabetes med could pressure Ozempic: analyst

Ozempic also boasts an approval for its ability to reduce the risk of cardiovascular events in diabetes patients with an established heart condition. For that marker, Lilly has the phase 3 Surpass-CVOT trial that’s pitting tirzepatide against its own GLP-1 agonist Trulicity, which also bears a CV outcomes label.

“[E]xperts we have spoken with would also like to see data from the ongoing cardiovascular outcomes trial … before using the product widely in their patients, given tirzepatide’s novel dual mechanism of action as a GLP-1 and GIP agonist,” Mizuho analyst Vamil Divan wrote in his note Thursday.

Since its launch in 2018, Ozempic has been prescribed to over 1.1 million people, Novo said. The company is confident the drug “will remain an important treatment option for adults with Type 2 diabetes based on its well-established efficacy, safety and tolerability profile, regardless of potential new treatment options that may become available,” Novo said in its statement.

RELATED: Novo Nordisk, following in Lilly's Trulicity footsteps, files higher Ozempic dose for diabetes

Plus, the growing GLP-1 class offers opportunities for multiple players, Jefferies analyst Peter Welford wrote in a Thursday note. With the new Lilly data, he still projects peak Ozempic sales of $7.8 billion after the drug generated $3.4 billion last year.

The new med will likely bring some pressure on Novo's market share, analysts say. Tirzepatide may tip the current GLP-1 balance in favor of Eli Lilly, even though it could cannibalize Lilly’s own fast-growing Trulicity, Welford said. For his part, Gal estimates the current 47% to 53% GLP-1 market split between Lilly and Novo, respectively, will shift in Lilly's favor, 55% to 45%, with tirzepatide’s launch.

The tirzepatide versus Ozempic head-to-head data also portend potential competition ahead for Novo in obesity, Gal and Welford both noted. The Danish company is seeking approvals for a 2.4 mg version of Ozempic as an obesity treatment. Gal viewed 15 mg tirzepatide’s efficacy in weight loss as favorable against Ozempic in the meds' separate trials, and Welford called the Lilly option a possible “strong competitor” to 2.4 mg Ozempic.