Novo, Lilly tout respective early response and weight loss maintenance data as GLP-1 rivalry intensifies

Eli Lilly and Novo Nordisk are building cases for their incretin drugs, both new and old, as attractive weight loss maintenance options and a potentially speedier option to shed pounds, respectively. 

The companies’ new data sets, which focused both on Lilly and Novo’s respective obesity injectables Zepbound (tirzepatide) and Wegovy (semaglutide), as well as the companies’ newer oral launches Foundayo (orforglipron) and the Wegovy pill, were presented early this week at the annual meeting of the European Congress on Obesity in Turkey. 

With regards to the original dosing formats, Lilly assessed the potential of a lower, 5-mg Zepbound dose to help patients keep weight off a year after taking a maximum titrated dose of its GIP/GLP-1 agonist. The Indianapolis drugmaker also took a look at Foundayo’s potential in the same setting, including for patients switching from Novo’s own Wegovy. 

For its part, Novo took the opposite approach with its injectable Wegovy results, highlighting the strength of its newly FDA-approved high-dose shot in a sub-analysis of its Step Up trial to help patients achieve greater weight loss faster than what was seen on the drug’s previous highest strength.

At the same time, Novo unveiled similar “early responder” results on its Wegovy pill, which has enjoyed impressive uptake since it beat Lilly’s Foundayo to the U.S. market at the start of the year. 

Novo’s data could help the company’s obesity franchise regain an edge over Lilly, which has overtaken it in the U.S. despite coming to market second with Zepbound and its Type 2 diabetes counterpart, Mounjaro. 

Lilly’s data, meanwhile, addresses a key concern for the broader GLP-1 class around the ability for patients to maintain weight loss after treatment with a high-dose incretin—a role that some industry watchers have suggested oral GLP-1s could fill. 

Digging into the numbers, Lilly’s Surmount-Maintain trial found that a low, 5-mg dose of Zepbound helped patients maintain weight loss after an initial 60 weeks of treatment with a maximum dose of either 10 or 15 mg. 

Specifically, patients switching to the lower dose injectable went from an average weight of 196.2 lbs after the maximum titrated dose back up to around 208.6 lbs 52 weeks into the maintenance treatment period, Lilly said, noting that its results leveraged an efficacy estimand method, which discounts results from patients who did not properly adhere to their treatment regimen. 

Lilly also highlighted data first dropped in December, which found that patients on its obesity pill Foundayo for maintenance regained some 5 kg (11 lbs) when switching from its own Zepbound and regained 0.9 kg (about 2 lbs) when pivoting from Novo’s Wegovy. 

"Obesity is a chronic disease requiring long-term treatment, and patients need more options they can stay on for the long run,” Kenneth Custer, Ph.D., Lilly’s EVP and president of cardiometabolic health, said in a statement Tuesday. 

He added that Lilly is “committed to providing people with multiple treatment options as they navigate their weight-loss journey."

 

Novo’s Wegovy riposte

 

As for Novo, the company is touting the impressive—and swift—weight loss potential of its new high dose (HD), 7.2 mg injectable Wegovy format, which received a U.S. green light in March. 

In a sub-analysis from its Step Up program, which pitted the HD format against the previous highest Wegovy dose of 2.4 mg over 72 weeks in adults with obesity who don’t have Type 2 diabetes, about 27% of patients on the 7.2 mg dose were classified as ‘early responders’ by Novo, meaning they lost 15% or more of their body weight within the first 24 weeks of treatment. Further, the early response group lost an average nearly 28% of their body weight at week 72, above the roughly 21% weight loss metric that won the HD injection its FDA nod. 

By comparison, roughly 21% of patients on the previous highest Wegovy dose—and 3% who received placebo—fell into that early responder bucket. 

The Danish drugmaker rolled out early responder data on its oral Wegovy option, too, noting that nearly one-third of patients who received the 25 mg semaglutide pill in the Oasis 4 clinical trial lost 13.2% of their weight on average after four months, for a total mean weight loss of 21.6% at the end of the trial, which ran for 64 weeks. 

Moreover, data from a separate Oasis 4 analysis found that the Wegovy pill helped “nearly eight in 10” people who entered the trial with poor physical function chart improvements to activities like range of motion and stamina, with similar weight loss results to the overall oral Wegovy cohort, Novo said. 

“Things many may take for granted, like the ability to stand for a length of time or simply bending down, can all be impacted by excess weight,” Martin Holst Lange, Novo’s chief scientist, explained in a statement. “These analyses of our trial data expand our understanding of the broader benefits of Wegovy pill, while reaffirming its best-in-class efficacy, tolerability and safety profile.”

The companies are rolling out their rival data as Novo currently enjoys a lead over Lilly in the newly unlocked oral obesity front. 

Over the first three months of the year, Novo reported that its Wegovy pill generated some 2.26 billion Danish kroner (around $355 million). As of April 17, some 2 million total oral Wegovy prescriptions had been written in the U.S., Novo’s EVP of U.S. operations, Jamey Millar, said on a conference call last week. 

Regarding Foundayo, Lilly’s obesity tablet generated around 7,335 total prescriptions in its fourth week since an April 9 launch, Citi analysts wrote to clients last week, citing prescribing stats from IQVIA. 

While that rollout looks slower on paper than Novo’s, the tracking of the Lilly drug’s launch—which Lilly said had reached around 20,000 patients on its first-quarter earnings call—may fail to properly account for a substantial volume of telehealth prescriptions for Foundayo, the Citi team said.