PHILADELPHIA — A second examine of the injectable anti-obesity remedy, semaglutide, has confirmed the big weight losses reported in a examine earlier this month, establishing the reliability and robustness of this new drug. With weight problems affecting greater than 40 % of American adults, the findings may have a significant impression on weight administration in major care and different settings. The study is printed immediately within the Journal of the American Medical Affiliation.
The 68-week examine was performed at 41 websites in the US from August 2018 to April 2020 and was designed to spice up whole weight reduction with semaglutide by combining the remedy with a extra intensive food regimen and bodily exercise program than what was used within the STEP 1 trial, printed on-line February tenth within the New England Journal of Drugs. All individuals within the new STEP 3 examine acquired 30 classes of intensive behavioral remedy consisting of food regimen and bodily exercise counseling, which was mixed with an preliminary 8-week, 1000-1200 kcal/day meal-replacement food regimen, consisting of shakes, meal bars, and ready entrees.
“We needed to induce a big weight reduction with rigorous behavioral remedy and see how a lot extra weight reduction semaglutide may add,” mentioned lead writer Thomas Wadden, PHD, a professor of psychology within the Division of Psychiatry on the Perelman Faculty of Drugs on the College of Pennsylvania.
The 611 individuals within the STEP 3 trial had a median beginning weight of 233 kilos with a physique mass index of 38 kg/m2. The individuals taking semaglutide got a 2.4 mg dose as soon as weekly. After 68 weeks of remedy, the semaglutide group misplaced a median of 16 % of baseline physique weight, equal to 37 kilos, in contrast with 5.7 %, 14 kilos for these assigned to intensive behavioral remedy mixed with placebo. Considerably higher proportions of semaglutide-treated individuals (75 %), in contrast with placebo (27 %), achieved weight losses of 10 % or extra of baseline weight.
“These are outstanding weight losses, significantly the one third of individuals who misplaced 20 % of baseline weight, a discount that approaches that achieved with sleeve gastrectomy, a extensively used bariatric surgical procedure process,” Wadden mentioned. “Additional examine is required to find out if sufferers can maintain these substantial losses with long-term use of semaglutide 2.4 mg.”
The bigger weight losses achieved with semaglutide than with placebo had been related to higher enhancements in cardiometabolic danger components, together with modifications in waist circumference, systolic blood stress, hemoglobin A1c, and triglycerides.
“These metabolic advantages and marked enhancements in danger components maintain nice promise for the prevention and remedy of diabetes and heart problems,” mentioned W. Timothy Garvey, MD, a examine co-author and professor of medication within the Division of Vitamin Sciences on the College of Alabama at Birmingham. “The unprecedented diploma of weight reduction can also be enough to forestall and deal with different issues of weight problems together with osteoarthritis, sleep apnea, and non-alcoholic fatty liver illness,” he added.
Gastrointestinal negative effects had been reported by 83 % of semaglutide individuals and included mild-to-moderate nausea and diarrhea that typically improved over time, with out the necessity to discontinue the drug.
Semaglutide is a glucagon-like-peptide 1 (GLP-1) receptor agonist which, at a dose of 1.0 mg as soon as weekly, is accredited (as Ozempic) by the U.S. Meals and Drug Administration for the administration of kind 2 diabetes. The upper dose of two.4 mg, at the moment being evaluated by the FDA for persistent weight administration, seems to have an effect on urge for food facilities within the mind that management starvation and cravings, resulting in a discount in meals and calorie consumption. Sufferers additionally report feeling full extra rapidly when consuming. The remedy is taken as soon as weekly by self-injection beneath the pores and skin.
“The outcomes with semaglutide look like the breakthrough in weight administration that well being care suppliers and their sufferers with weight problems have been ready for,” mentioned Wadden. “It is clear that including semaglutide to intensive behavioral remedy may considerably improve the proportions of sufferers who lose 10 % or extra of their beginning weight, with accompanying enhancements in well being and mobility.”
A query left unanswered by the current examine is how a lot way of life counseling is required with semaglutide to lose a median of roughly 15 % of baseline weight. Semaglutide-treated individuals within the STEP 1 trial misplaced 14.9 % of beginning weight, with 18 classes of way of life counseling, in contrast with 2.4 % for placebo.
“For the placebo-treated individuals in STEP 3, the 30 intensive behavioral remedy classes and meal-replacement food regimen appeared to extend weight reduction by roughly 3 proportion factors, as in contrast with the much less intensive way of life counseling offered within the STEP 1 trial,” Wadden famous. “Nonetheless, a comparable profit was not noticed in combining rigorous behavioral remedy with semaglutide, suggesting that additional examine is required of the optimum program of way of life counseling required with semaglutide on the larger dose at the moment being evaluated.”
The examine was funded by Novo Nordisk.
Editor’s Notice: Wadden and Garvey serve on a scientific advisory board for Novo Nordisk.
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