Novo Nordisk A/S (NYSE:NVO) reportedly said on Tuesday that it intends to seek US regulatory approval for a high-dose version of its weight-loss injection Wegovy (semaglutide), another effort to counter Eli Lilly and Co. (NYSE:LLY).
Martin Holst Lange, chief scientific officer at Novo Nordisk, confirmed the company's intentions Tuesday during the European Association for the Study of Diabetes conference in Vienna. Although the company has not yet formally announced its plans, it is preparing to submit an application to the U.S. Food and Drug Administration (FDA) for approval.
Also Read: Wegovy And Zepbound Cost Effective But They Could Break Drug Budgets
High-dose Wegovy offers the same weight-loss potential as Lilly's Zepbound, giving patients another option, Lange told Bloomberg in an interview.
"Obviously, our competitors have optimized the dosing," Lange said. "Now with high-dose Wegovy, we've done the same."
Novo Nordisk presented data from a sub-analysis of the phase 3 REDEFINE 1 trial at the European Association for the Study of Diabetes (EASD) congress 2025.
This sub-analysis evaluated the efficacy and safety of once-weekly cagrilintide 2.4 mg monotherapy, plus lifestyle intervention, for adults with obesity or overweight and a weight‑related comorbidity without diabetes.1
In REDEFINE 1, cagrilintide provided clinically meaningful weight loss, with an average body weight reduction of 11.8% compared to 2.3% with placebo after 68 weeks.
Additionally, around 1 in 3 participants (31.6%) receiving cagrilintide achieved ≥15% weight loss, compared to around 1 in 20 participants (4.7%) receiving placebo.
When evaluating the treatment effect regardless of adherence, average weight loss with cagrilintide was 11.5% compared to 3.0% with placebo after 68 weeks.
Additionally, 31.0% of participants achieved ≥15% weight loss with cagrilintide compared to 5.2% with placebo.
The dedicated phase 3 RENEW program will investigate the efficacy and safety of cagrilintide in people with obesity or overweight and is due to start in the fourth quarter of 2025.
Citing an internal memo, Bloomberg noted that Novo Nordisk is downgrading the titles of some of its most senior managers as part of a sweeping overhaul by its new CEO, Maziar Mike Doustdar.
As per the memo, many leaders at the company will assume new titles by early next year to better align the drugmaker with global industry peers.
Last week, Novo Nordisk announced a significant restructuring plan that will result in the company cutting 9,000 jobs, representing 11.5% of its workforce. The restructuring is expected to save Novo Nordisk approximately $1.3 billion annually.
Price Action: NVO stock is up 2.93% at $57.25 at the last check on Tuesday.
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