Novo Nordisk has applied to the European Medicines Agency (EMA) for a new, increased dosage of Wegovy® (semaglutide), a well-known medication for weight loss, of 7.2 mg. Given that clinical trial data indicates a substantially higher reduction in weight than the currently available doses, this move intends to provide individuals with obesity a more potent option.
Data from the STEP UP and STEP UP T2D clinical studies support the application. Adults with obesity but not type 2 diabetes who took 7.2 mg of Wegovy® experienced an average weight loss of 21% in the STEP UP study. Remarkably, over one-third of trial participants lost at least 25% of their body weight. The greater dose was tested in individuals with type 2 diabetes and obesity in the STEP UP T2D experiment, which also showed promising outcomes.
The submission of this new dose of Wegovy® is another step forward in providing innovative solutions that meet the specific needs of people with obesity,
This new dose was developed as a tailored option for people in need of additional support to achieve meaningful, sustained weight loss. With a reaffirmed safety and tolerability profile, we strongly believe in its potential to help even more people with obesity reach their individual weight loss as well as their broader health goals, including improvements in cardiovascular and kidney health, liver disease, type 2 diabetes and mobility through knee osteoarthritis pain reduction.
Ludovic Helfgott
Other clinical investigations of semaglutide and the previously approved 2.4 mg dose of Wegovy® were found to be consistent with the safety profile of the 7.2 mg dose. This implies that patients are able to handle the increased dosage.
About the STEP UP trials
The purpose of the 72-week STEP UP experiment was to examine the safety and effectiveness of semaglutide 7.2 mg vs semaglutide 2.4 mg and placebo as a supplement to a lifestyle intervention. It was a parallel-group, double-blind, placebo-controlled, superiority trial. 1,407 adults without diabetes who had a BMI of 30 kg/m2 were involved in the trial. The main goal was to show that semaglutide 7.2 mg was more effective at promoting weight loss than a placebo. Important secondary endpoints for confirmation were the proportion of participants who lost 10%, 15%, 20%, and 25% of their body weight, respectively.
Two studies, STEP UP and STEP UP T2D, have been finished by Novo Nordisk to examine the safety and effectiveness of semaglutide 7.2 mg in obese individuals with or without type 2 diabetes.
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