Novo Nordisk’s high-dose version of its obesity drug, Wegovy, showed greater weight loss than the currently approved dose in a Phase III trial, the company announced on Friday. However, the results indicate that Eli Lilly’s competing GLP-1 drug, Zepbound, may still have a slight advantage over Wegovy.
Wegovy, which contains semaglutide, is currently prescribed at a maintenance dose of 2.4 mg. Novo Nordisk conducted the STEP UP Phase III trial to test whether increasing the dose to 7.2 mg could produce better results. The trial involved 1,407 adults with obesity, but without diabetes, who were randomly assigned to receive either 7.2 mg or 2.4 mg of semaglutide, or a placebo.
After 72 weeks of weekly injections, patients on the 7.2 mg dose lost an average of 18.7% of their body weight. In comparison, those on the 2.4 mg dose lost 15.6%, while placebo users lost only 3.9%. Notably, one-third of participants on the higher dose lost at least 25% of their body weight, compared to 16.7% of those on the lower dose. Novo Nordisk indicated that the higher dose could significantly increase the weight loss benefits for users of Wegovy.
This improvement in efficacy could be key for Novo Nordisk as it competes for market share. In December, Eli Lilly’s Zepbound outperformed Wegovy in a Phase IIIb trial. The SURMOUNT-5 trial showed that patients using Zepbound lost 20.2% of their body weight over 72 weeks, slightly higher than Wegovy’s latest results. However, cross-trial comparisons can be misleading.
Martin Holst Lange, executive vice president of development at Novo Nordisk, previously set expectations for the 7.2 mg dose during the company’s capital markets day in March. He noted that the company’s models suggested the higher dose could lead to weight loss of 20% to 21% without compromising safety or tolerability.
Novo also presented an analysis of the STEP UP trial, showing a potential weight loss of 20.7% with the 7.2 mg dose if all participants adhered to treatment. For the 2.4 mg dose, the weight loss was 17.5%, while those on the placebo lost only 2.4%.
In a note to investors, analysts from Leerink Partners compared the 7.2 mg Wegovy data to results from Eli Lilly’s tirzepatide, which showed a 20.1% weight loss after 72 weeks in a similar Phase III trial. They stated that these results increase their confidence in tirzepatide’s long-term market share, adding that historical data showed better tolerability for tirzepatide compared to semaglutide at the 2.4 mg dose. They are awaiting further results from the STEP UP trial, expected to be presented at a medical conference later this year.
