Once weekly administration of the type-2 diabetes drug semaglutide (Ozempic) was linked to a sustained, clinically relevant reduction in body weight in obese adult participants in the STEP 1 clinical trial, according to the Northwestern University Feinberg School of Medicine, US.
The double-blind trial was funded by the pharmaceutical company Novo Nordisk. The study 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 co-primary endpoints of the study was a percentage change in body weight and weight reduction of at least 5%.
Participants started from an average baseline weight of 230 pounds and a body mass index of 38 kg/m2. They saw an average weight loss of 14.9% (34 pounds) compared with 2.4% (5 pounds) for the placebo group, according to the press release.
Approximately 70% of study participants reached a clinically relevant weight loss of at least 10% of their baseline body weight, said corresponding author Robert Kushner, MD, a professor of medicine and medical education at Northwestern University Feinberg School of Medicine, in a press release.
“A lot of the health concerns we see in people who are struggling with their weight, such as diabetes, high blood pressure, or gastroesophageal reflux disease, tend to improve when they reach a weight loss of 10%,” Kushner said in the press release.
Furthermore, the investigators said one-third of study participants treated with semaglutide lost at least 20% (46 pounds) of their baseline weight, which is a common reduction for many patients who have had bariatric surgery in the 1 to 3 years following their procedure.
“It’s the very first time we have a medication that even begins to approach the weight loss people achieve with bariatric surgery,” Kushner said adding that bariatric surgery is still more effective than this medication, but surgery carries additional risks
In addition, subjects receiving semaglutide had a greater improvement on cardiometabolic risk factors and a greater betterment in physical function from baseline versus placebo, said the researchers.
Novo Nordisk, in September 2019, had reported positive results from the phase IIIa PIONEER clinical trial programme of oral semaglutide to treat type 2 diabetes patients. 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.
The company sought approval in December 2020 for semaglutide for weight management from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).