- STEP UP trial showed Wegovy® users lost an average of 21% body weight.
- Semaglutide 7.2 mg and 2.4 mg doses were compared in the trial.
- Novo Nordisk expects EMA decision on Wegovy® by year-end.
- Wegovy® is under review in the EU, UK, and other countries.
Study Findings
The STEP UP trial demonstrated that Wegovy® users achieved significant weight loss, with an average reduction of 21% in body weight. The trial compared the efficacy of semaglutide doses of 7.2 mg and 2.4 mg, showing that more users reached a BMI under 27 and a waist-to-height ratio below 0.53 compared to placebo.
Health Benefits
Participants who met both BMI and waist-to-height ratio targets also saw improvements in cardiovascular risk factors, including blood pressure, cholesterol, and blood sugar levels. Over half of these participants reached healthy levels for all four cardiovascular risk factors, indicating a reduced risk of cardiovascular disease.
Regulatory Review
The new, higher dose of Wegovy® (semaglutide 7.2 mg) is under review by the European Medicines Agency (EMA), with a decision expected around the end of the year. The drug is also under review in the UK and several other countries, with plans to submit to the US Food and Drug Administration.
Trial Details
The STEP UP trial was a 72-week, randomized, double-blinded, placebo-controlled study involving 1,407 adults with a BMI of 30 kg/m² or greater. It aimed to demonstrate the superiority of semaglutide 7.2 mg over placebo in achieving weight loss. A related trial, STEP UP T2D, focused on individuals with obesity and type 2 diabetes, further exploring the efficacy of semaglutide 7.2 mg.
