Outcomes exhibiting once-weekly subcutaneous semaglutide, as an adjunct to intensive behavioral remedy and an preliminary low calorie weight loss plan, induced weight reduction that was 10.3% better in contrast with placebo over 68 weeks in individuals with obesity or chubby, have been published today in JAMA.
The findings, from the part 3, randomized, double-blind STEP 3 examine for the glucagon-like peptide-1 (GLP-1) agonist, have been first reported in the course of the virtual ObesityWeek® Interactive 2020 meeting.
The STEP 3 examine is a part of the worldwide Semaglutide Remedy Impact in Individuals With Weight problems program of 4 trials (STEP 1, 2, 3, and 4) of the security and efficacy of subcutaneous semaglutide 2.4 mg/week for weight reduction.
Subcutaneous semaglutide is already accepted for treating type 2 diabetes (as Ozempic, Novo Nordisk) in adults at doses of as much as 1 mg/week; larger doses are wanted for weight reduction.
The STEP trial program is now full, and Novo Nordisk submitted information to the US Food and Drug Administration and the European Medicines Agency final December. A call on approval is predicted inside 6 months from submitting. The proposed indication is for the remedy of adults with weight problems (physique mass index [BMI] ≥ 30 kg/m2) or chubby (BMI ≥ 27 kg/m2) and not less than one weight-related comorbidity, as an adjunct to a reduced-calorie weight loss plan and elevated bodily exercise.
“The current findings counsel that the addition of semaglutide to intensive behavioral remedy could assist sufferers obtain greater than the common 5% to 10% discount in physique weight sometimes produced by behavioral interventions at 6 to 12 months,” write Thomas A. Wadden, PhD, from the Perelman Faculty of Drugs on the College of Pennsylvania, Philadelphia, and colleagues.
“Weight reduction with behavioral remedy typically plateaus at this degree, regardless of sufferers’ persevering with to have weight problems,” they add.
Outcomes from the STEP 1 trial have been additionally just lately printed within the New England Journal of Drugs, as reported by Medscape Medical Information.
One of many coauthors of that trial, Rachel Batterham, MBBS, PhD, of the Centre for Weight problems Analysis at College School, London, UK, mentioned: “The findings of this examine symbolize a significant breakthrough for enhancing the well being of individuals with weight problems. No different drug has come near producing this degree of weight reduction — this actually is a sport changer. For the primary time, individuals can obtain by means of medicine what was solely doable by means of weight-loss surgery.”
STEP 3 Outcomes: Extra GI Facet Results With Semaglutide
STEP 3 concerned 611 adults with out diabetes who have been both chubby and had a least one comorbidity or had weight problems. All individuals acquired a low-calorie weight loss plan (1000-1200 kcal/day) for 8 weeks post-randomization, adopted by a weight loss plan of 1200-1800 kcal/day for the rest of the 68 weeks. They have been additionally requested to train for 100-200 minutes/week and acquired 30 particular person intensive behavioral remedy visits. Members have been randomized (2:1) to semaglutide 2.4 mg (n = 407) or placebo (n = 204).
At week 68, imply physique weight reduction was –16.0% for semaglutide in contrast with –5.7% for placebo, a imply distinction of −10.3 proportion factors (P < .001). And extra individuals handled with semaglutide versus placebo misplaced not less than 5% of their baseline physique weight (86.6% vs 47.6%; P < .001). Collectively these have been the coprimary endpoints.
Extra individuals within the semaglutide group achieved weight lack of not less than 10% (75.3% vs 27.0%; P < .001) or 15% (55.8% vs 13.2%; P < .001) in contrast with placebo.
Extra sufferers taking semaglutide skilled gastrointestinal adversarial occasions in contrast with placebo (82.8% vs 63.2%), and three.4% of individuals taking semaglutide discontinued remedy in comparison with none taking placebo.
As a comparability, an identical program of intensive behavioral remedy (with out meal replacements) of sufferers taking the GLP-1 agonist liraglutide 3.0 mg (Saxenda, Novo Nordisk) or placebo resulted in imply losses of seven.5% and 4.0% of baseline physique weight, respectively, at 56 weeks.
A head-to-head comparison of liraglutide and semaglutide is at the moment underway (in STEP 8).
Wadden and colleagues say the query stays as as to whether long-term weight reduction with semaglutide requires intensive behavioral remedy and an preliminary low-calorie meal alternative weight loss plan as a result of, in STEP 1, individuals misplaced 14.9% of baseline weight with semaglutide, in comparison with 2.4% with placebo, at 68 weeks with a a lot much less intensive way of life intervention and no preliminary low-calorie weight loss plan.
Semaglutide is also approved as a once-daily oral agent for sort 2 diabetes (Rybelsus, Novo Nordisk) in doses of seven mg and 14 mg to enhance glycemic management together with weight loss plan and train. It’s the first GLP-1 agonist accessible in pill type.
JAMA. Revealed on-line February 24, 2020. Abstract
The trial was funded by Novo Nordisk. Wadden has reported receiving grants and private charges from Novo Nordisk, in addition to private charges from WW Worldwide (previously Weight Watchers). Disclosures for the opposite authors are listed within the article.