In the ongoing quest to expand semaglutide’s clinical pedigree and cement the GLP-1's market position, Novo Nordisk is rolling out new data on a higher-dose injection in obesity.
In the phase 3b STEP UP study, an experimental 7.2-mg semaglutide dose helped patients lose more weight on average at 72 weeks compared to placebo or semaglutide 2.4 mg, which is currently the highest dose of the drug marketed under the Wegovy brand for obesity.
Digging into the data, participants in the 1,407-patient trial started from a mean baseline body weight of 113 kg (about 249 pounds). Those who received once-weekly semaglutide 7.2 mg lost 20.7% of their body weight on average after 72 weeks versus 17.5% weight loss with semaglutide 2.4 mg and just 2.4% weight loss in the trial’s placebo arm.
Further, 33.2% of patients on the highest semaglutide dose achieved weight loss of at least 25% after the 72-week mark, versus 16.7% of patients on semaglutide 2.4 mg and 0% of patients on placebo who hit that magnitude of success.
Overall, semaglutide 7.2 mg appeared safe and well tolerated in the study, with the most common adverse events the sort of mild to moderate gastrointestinal side effects that are consistent across the GLP-1 receptor agonist class of drugs.
“We are very pleased to demonstrate 20.7% weight loss and to see that 33% of patients achieved more than 25% weight loss with semaglutide 7.2 mg, with a safety and tolerability profile comparable to semaglutide 2.4 mg,” Martin Holst Lange, Novo’s executive vice president for development, said in a statement.
Novo said it plans to share detailed results from STEP UP at an upcoming medical meeting. The company is also testing semaglutide 7.2 mg in a separate phase 3 study, STEP UP T2D, which is looking at the higher dose in adults with Type 2 diabetes and obesity. That trial is expected to read out “within the next few months.”
Despite the company’s enthusiasm, questions remain about how Novo's latest numbers can move the needle in a competitive market. The company's stock price decline of 4% on Friday seems to indicate investors aren't convinced yet.
Of course, that stock performance could also be indicative of the fact that Wegovy and Ozempic, along with their oral sibling Rybelsus, have been named as part of the next tranche of drugs to undergo Medicare price negotiations as part of the Inflation Reduction Act.
Meanwhile, Novo has been locked in near-constant competition with its metabolic medicine rival Eli Lilly, which markets counterparts to Ozempic and Wegovy in the forms of Mounjaro and Zepbound.
Early last month, Lilly posted a win in a head-to-head trial pitting the highest doses of Zepbound and Wegovy against one another. Results from the SURMOUNT-5 study, which included 751 participants from the U.S. and Puerto Rico, found that patients on Lilly’s drug lost an average of 20.2% of their weight after 72 weeks, while those taking Wegovy lost 13.7% of their weight in the same span of time.