The duel of the GLP-1 data sets continues this week, with Novo issuing the latest salvo of updates on its oral obesity candidate and an Ozempic head-to-head trial win against another stalwart diabetes treatment.
In the wake of the results—which concern the performance of an oral formulation of Wegovy and a real-world head-to-head study of Ozempic against Eli Lilly’s legacy GLP-1 Trulicity—Novo’s stock was up more than 7% in premarket trading Thursday.
Over the past year, Novo’s share price has dropped precipitously as the company lost commercial ground to Lilly and compounding pharmacies producing copycat GLP-1s.
The obesity data on oral semaglutide 25 mg, which Novo has dubbed “Wegovy in a pill,” come at a crucial time, given Lilly’s data drop on its own oral weight loss candidate, orforglipron, earlier this week.
At the 64-week mark in Novo’s Oasis 4 trial, oral Wegovy participants that adhered to treatment achieved an average weight loss of 16.6%, compared to just 2.7% average weight loss for patients on placebo. Further, 34.4% of patients who took Novo’s oral obesity option as prescribed lost 20% or more of their body weight, versus 2.9% of patients in the trial’s control arm, Novo said in a Sept. 17 press release.
Those results are largely on par with the efficacy observed in prior studies of injectable Wegovy, Novo said.
When accounting for adherence issues, the average weight loss observed in the study’s Wegovy arm worked out to 13.6%, versus 2.2% on placebo, according to data published in The New England Journal of Medicine on Wednesday. By that same token, the overall proportion of oral Wegovy patients who achieved 20% or greater average weight—regardless of whether they “took the medicine exactly as they should”—rounded out to 29.7%, Novo said.
In the trial, 205 participants received oral Wegovy, while the remaining 102 patients were given a dummy drug. Patients in the Wegovy arm were “significantly more likely” to hit several ascending weight loss benchmarks than those on placebo, but rates of gastrointestinal side effects were also higher in the treatment cohort, according to the NEJM publication.
The study specifically looked at patients with obesity or who were overweight with at least one weight-related comorbidity but who did not have diabetes.
Aside from its weight loss showing, oral Wegovy also appeared to improve cardiovascular risk factors and help patients become more active in daily life versus placebo, Novo said in its release.
“Currently, less than 2% of individuals with obesity in the U.S. receive obesity medication and Wegovy in a pill may also address patient preference for oral treatment,” Martin Holst Lange, M.D., Ph.D., Novo’s chief scientific officer and executive vice president of R&D, said in a statement.
As Novo and Lilly race toward approvals of their oral GLP-1s for obesity, Novo currently has the lead. The company submitted a regulatory filing for its Wegovy pill in April, and the FDA is currently expected to render its verdict on approval sometime in the fourth quarter. Lilly, by contrast, has indicated that it’s gearing up for global regulatory submissions for orforglipron, with the expectation that obesity nods could start rolling in next year.
In its release, Novo stressed that its Wegovy pill will be “fully made in the U.S.,” adding that it has already started manufacturing the oral GLP-1 ahead of the FDA approval decision.
“Pending FDA approval, ample supply will be available to meet the expected US demand as we hope to set a new treatment benchmark for oral weight loss medications for people with overweight or obesity,” said Lange.
As it stands, Novo’s oral Wegovy data look slightly better than those for orforglipron, which helped patients lose, on average, 12.4% of their body weight in a phase 3 trial. Nevertheless, cross-trial comparisons are fickle, failing to account for differences in trial populations and other factors.
Challenging Trulicity
Following the oral Wegovy data drop, Novo on Thursday unveiled Trulicity-topping results from a real-world Ozempic head-to-head trial.
In that study, dubbed Reach, once-weekly injectable Ozempic curbed the risk of major adverse cardiovascular events—like heart attack or stroke—by 23% compared to Trulicity in Type 2 diabetes patients who also had cardiovascular disease. The data, which span nearly 60,000 U.S. Medicare patients ages 66 years and older, were presented at the annual meeting of the Association for the Study of Diabetes in Vienna this week.
Novo’s Ozempic—which was first approved for diabetes in 2017—was also linked to a 25% risk reduction for heart attack, stroke, hospitalization for unstable angina or heart failure, and death from any cause, the company said.
Lilly’s drug Trulicity, also approved in diabetes, was originally cleared by the FDA in 2014. Both medicines carry additional indications for cardiovascular risk reduction.