November 13, 2020
2 min learn
Wadden TA. Semaglutide 2.4 mg and intensive behavioral remedy in topics with chubby or weight problems (STEP 3). Offered at: ObesityWeek Interactive; Nov. 5, 2020 (digital assembly).
Wadden stories he has served on the scientific advisory board for Novo Nordisk and has served on the scientific advisory board and acquired grants from Weight Watchers.
Adults who acquired a once-weekly 2.4 mg dose of semaglutide along with intensive behavioral remedy misplaced extra weight at 68 weeks than those that acquired placebo, based on trial information introduced at ObesityWeek Interactive.
Thomas A. Wadden
“As adjunct to intensive behavioral remedy, semaglutide 2.4 mg elevated weight reduction by 10.3 share factors in contrast with placebo,” Thomas A. Wadden, PhD, the Albert J. Stunkard professor of psychiatry on the Perelman College of Drugs, College of Pennsylvania, mentioned throughout a presentation. “That is the most important placebo-subtracted weight reduction that I’m conscious of for a monotherapy for weight problems.”
Wadden introduced information from STEP 3, a 68-week, randomized, double-blind, placebo-controlled trial through which 611 adults (81% ladies; imply age, 46 years; 76.1% white) with chubby or weight problems who didn’t have diabetes had been randomly assigned to a 2.4 mg dose of semaglutide (Ozempic, Novo Nordisk) as soon as per week or placebo, along with intensive behavioral remedy. Contributors acquired an escalating dose of semaglutide or placebo for the primary 16 weeks. The two.4 mg of semaglutide was then administered for 1 12 months, ending at week 68 of the trial.
Each the semaglutide and placebo teams had the identical intensive behavioral remedy program, which consisted of 30 15-minute classes delivered by a registered dietitian. Contributors ate a low-calorie weight loss program for the primary 8 weeks, adopted by a hypocaloric weight loss program based mostly on physique weight at randomization. Bodily exercise began at 100 minutes of moderate-intensity train per week at randomization. Contributors had been requested to extend their train by 25 minutes each 4 weeks, as much as a goal of 200 minutes per week.
At week 68, the semaglutide cohort misplaced 10.3 share factors (16% vs. 5.7%) extra weight than the placebo group (95% CI, –12 to –8.6; P < .0001). Within the semaglutide group, 75.3% of individuals achieved a weight lack of 10% or larger through the trial interval in contrast with 27% for placebo, and 55.8% of these receiving semaglutide had a weight lack of 15% or larger vs. 13.2% for placebo.
The semaglutide group additionally had a larger enchancment in comorbidities in contrast with placebo, together with bigger reductions in waist circumference (estimated distinction = –14.6 cm; 95% CI, –10.1 to –6.6; P < .0001), HbA1c (estimated distinction = –0.24%; 95% CI, –0.29 to –0.19; P < .0001), systolic blood stress (estimated distinction = –3.9 mm Hg; 95% CI, –6.4 to –1.5; P < .01), diastolic BP (estimated distinction = –2.2 mm Hg; 95% CI, –3.9 to –0.6; P < .01) and C-reactive protein (estimated distinction = –48%; 95% CI, –55 to –39; P < .0001).
Most hostile occasions within the trial had been thought-about gentle. The most typical occasions within the semaglutide cohort had been gastrointestinal issues, together with nausea, vomiting, diarrhea and constipation, with 82.8% of individuals reporting these signs. The semaglutide group had 9.1% of its individuals report extreme hostile occasions. Wadden mentioned this price was pushed by gall bladder-related occasions, in addition to points unrelated to semaglutide. Wadden added that the protection findings for semaglutide 2.4 mg had been corresponding to those found with semaglutide 1 mg and liraglutide 3 mg (Saxenda, Novo Nordisk).
“These are promising outcomes that present that combining semaglutide 2.4 mg with intensive conduct remedy will assist a larger share of sufferers obtain their objective weight, and people bigger weight losses will assist to enhance comorbidities related to weight problems and to enhance sufferers’ high quality of life,” Wadden mentioned.