Copyright Benzinga
At the ObesityWeek, Novo Nordisk A/S (NYSE:NVO) presented new findings from the STEP UP phase 3b trial. The Novo Nordisk STEP UP phase 3b trial investigated the efficacy and safety of a higher, 7.2 mg dose of semaglutide compared to the 2.4 mg dose and a placebo for weight management in adults with obesity. It showed that Wegovy helps obese people lose an average of 21% of their body weight. The company on Thursday said Wegovy also enabled the participants to achieve treatment targets linked to a low risk of obesity-related complications. Data The results applied to both the approved semaglutide 2.4 mg dose and the investigational higher 7.2 mg dose. In the STEP UP sub-analysis, more people with obesity who received Wegovy achieved the target BMI of less than 27, as well as a waist-to-height ratio of less than 0.53. Specifically, 19.5% of those on semaglutide 7.2 mg and 13.2% on semaglutide 2.4 mg met these targets, compared to 0% for placebo. People treated with Wegovy who achieved both treatment targets reached healthy levels for two or more cardiovascular risk factors, including blood pressure, cholesterol, and blood sugar levels. Over half of the participants who achieved both BMI and waist-to-height ratio targets with Wegovy reached healthy levels for all four cardiovascular risk factors, indicating a low risk of cardiovascular disease. The new, higher dose of Wegovy (semaglutide 7.2 mg), investigated in two STEP UP trials, is currently under review with the European Medicines Agency (EMA), in the U.K., and several other countries. In the EU, Novo Nordisk expects a regulatory decision around the turn of the year. Novo Nordisk also expects to submit to the U.S. Food and Drug Administration. Novo Nordisk also presented new data from the OASIS 4 phase 3 trial of oral semaglutide 25 mg. Results showed that in the overall trial population, a higher percentage of participants with pre-diabetes at baseline achieved normal blood glucose (sugar) at week 64 in the semaglutide group versus placebo (71.1% versus 33.3%). Participants treated with oral semaglutide 25 mg were more likely to achieve ≥15% body weight reduction, compared with those who received a placebo. Within the semaglutide group, more people who achieved ≥15% body weight reduction saw larger improvements than those with <15% weight reduction in blood pressure readings. 71.1% Achieved Normal Blood Glucose Reductions in levels of inflammatory marker C-reactive protein and in lipids (blood fats) were also observed. Oral semaglutide 25 mg (Wegovy in a pill) is not FDA approved. In February, Novo Nordisk submitted a New Drug Application (NDA) for the once-daily pill formulation of Wegovy. The FDA review of this NDA is anticipated to be completed by the end of this year. Currently, there are no approved oral formulations of a GLP-1 medicine for weight loss. NVO Price Action: Novo Nordisk shares were down 2.31% at $47.34 at the time of publication on Thursday. The stock is near its 52-week low of $45.05, according to Benzinga Pro data. Read Next: China Eases US Tariffs, Scraps Farm Levies As Trump Cuts Fentanyl Duties In Fresh Trade Truce Image via Shutterstock
