Results from the STEP UP trial show that a high-dose formulation of Wegovy can significantly increase the weight loss effects the drug is known for.
Novo Nordisk has announced topline results from the phase 3b trial STEP UP, which investigated the effects of two doses of Wegovy (semaglutide) in over 1,400 patients over the course of 72 weeks. Both formulations were delivered subcutaneously once a week and were accompanied by lifestyle changes.
The results have shown that patients treated with the higher dose (7.2 mg) achieved a 20.7% weight loss after 72 weeks, while patients treated with the standard approved dose (2.4 mg) showed a 17.5% weight reduction.
Furthermore, 33.2% of patients treated with the higher dose reached a weight loss of 25% or more, while only 16.7% of patients treated with the lower dose achieved the same.
In comparison, those who were treated with a placebo showed a 2.4% weight reduction, and none achieved a weight loss of 25% or more.
Detailed results will be presented at a scientific conference later this year.
Safety and tolerability profile
The higher dose showed a safe and well-tolerated profile during the trial, with the most common adverse effects being mild to moderate gastrointestinal symptoms that diminished over time, consistent with the effects of drugs targeting the glucagon-like protein-1 (GLP-1) receptor.
“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,” said Martin Holst Lange, executive vice president for development at Novo Nordisk.
Effects of semaglutide
Building on the massive success that GLP-1 drugs, including Wegovy and Ozempic, have seen in the past year, Novo Nordisk has been conducting multiple studies to further investigate the effects of semaglutide, the active ingredient in both drugs.
In November, the company released results from the SELECT trial showing that the drug could significantly reduce hospital admissions in overweight and obese adults with heart disease.
Another phase 3 study, STEP UP T2D, is currently ongoing to compare the effects of the higher and standard doses of Wegovy in patients with T2 diabetes.
“Results from STEP UP further strengthen the clinical profile of semaglutide for the treatment of obesity, in addition to the health benefits already established with Wegovy, including cardiovascular risk reduction as seen in SELECT,” said Lange.
