Northwestern University Feinberg School of Medicine in the US has reported that results from STEP 1 clinical trial of type-2 diabetes drug semaglutide (Ozempic) once weekly was linked to a sustained, clinically relevant reduction in body weight in obese adult participants.
The double-blind trial is funded by Novo Nordisk, which manufacturers Rybelsus and Ozempic (semaglutides for treating diabetes).
It had 1,961 subjects with a body-mass index (BMI) of 30 or above without diabetes. They were randomised into a 2:1 ratio to receive a once-weekly subcutaneous injection of semaglutide 2.4mg or placebo, along with lifestyle interventions, for 68 weeks.
The percentage change in body weight and weight reduction of at least 5% were the study’s co-primary endpoints.
According to the results, Semaglutide group showed an average reduction in body weight from baseline of 14.9% versus 2.4% in the placebo group, indicating a treatment difference of 12.4%.
Furthermore, 86.4% of subjects in the semaglutide group achieved weight reductions of 5% as compared with 31.5% in the placebo group, respectively.
Half of the subjects receiving semaglutide achieved a weight reduction of 15% or more versus 4.9% in the placebo group.
Northwestern Medicine internal medicine physician and Division of Endocrinology and of Medical Education Medicine professor Robert Kushner said: “This is by far the most effective intervention we have seen for weight management when you compare it to many of the currently existing drugs.
“Semaglutide sets the bar for a new generation of more effective weight-loss medications.”
In addition, subjects receiving semaglutide had a greater improvement on cardiometabolic risk factors and a greater betterment in physical function from baseline versus placebo.
Currently, oral semaglutide is marketed in the EU as Rybelsus for treating type II diabetes as an adjunct to diet and exercise for adults with uncontrolled condition.
In September 2019, Novo Nordisk reported positive results from the Phase IIIa PIONEER clinical trial programme of oral semaglutide to treat type 2 diabetes patients.
Last December, the company sought approval for the once-weekly semaglutide for weight management from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).