The Feinberg School of Medicine at Northwestern University in the US has reported that the results of the STEP 1 clinical trial of the type 2 diabetes drug semaglutide (Ozempic) once a week produced sustained, clinically relevant body weight reductions in obese adults Participants have been linked.
The double-blind study is funded by Novo Nordisk, which makes Rybelsus and Ozempic (semaglutide, used to treat diabetes).
It had 1,961 subjects with a body mass index (BMI) of 30 or more without diabetes. They were randomized in a 2: 1 ratio to receive a weekly subcutaneous injection of 2.4 mg semaglutide or placebo along with lifestyle interventions for 68 weeks.
The percent change in body weight and weight loss of at least 5% were the co-primary endpoints of the study.
According to the results, the semaglutide group showed an average decrease in body weight of 14.9% from baseline versus 2.4% in the placebo group, indicating a treatment difference of 12.4%.
In addition, 86.4% of the subjects in the semaglutide group achieved a weight reduction of 5% compared to 31.5% in the placebo group.
Half of the subjects who received semaglutide achieved a weight loss of 15% or more compared to 4.9% in the placebo group.
Robert Kushner, Internist in Northwest Medicine and Professor of Endocrinology and Medicine for Medical Education, said, “This is by far the most effective intervention we have seen for weight management when compared to many of the drugs currently in existence.
“Semaglutide sets the bar for a new generation of more effective weight loss drugs.”
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In addition, subjects who received semaglutide showed greater improvement in cardiometabolic risk factors and greater improvement in physical function from baseline compared to placebo.
Oral semaglutide is currently being marketed in the EU as Rybelsus for the treatment of type II diabetes as a diet and exercise supplement for adults with an uncontrolled condition.
In September 2019, Novo Nordisk reported positive results from the Phase IIIa PIONEER clinical trial program with oral semaglutide for the treatment of type 2 diabetes patients.
Last December, the company filed for approval of once-weekly semaglutide for weight control with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
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