A second study of the injectable anti-obesity medication, semaglutide, has confirmed that the major weights reported in an earlier study this month establish the reliability and potency of this new drug. With obesity affecting more than 40 percent of American adults, the findings could have a significant impact on stress management in primary care and other settings. The study is published today in the Journal of the American Medical Association.
The 68-week study was conducted at 41 sites in the United States from August 2018 to April 2020 and was designed to promote total weight loss with semaglutide by combining the medication with a more diet and physical activity program. intensity than that used in the STEP 1 test, published online February 10th in the New England Journal of Medicine. All participants in the new STEP 3 study received 30 sessions of intensive behavioral therapy including diet and physical activity counseling, combined with an 8-week, 1000-1200 kcal food replacement diet. / day, in which snacks, food bars, and entrances are prepared.
“We wanted to encourage extreme weight loss with tight behavior therapy and see what effect semaglutide could add to additional weight loss,” said lead author Thomas Wadden, PHD, professor of psychology in the Department of Science at the Perelman School of Medicine at the University of Pennsylvania.
The 611 participants in the STEP 3 test had an average starting weight of 233 pounds with a body index of 38 kg / m2. Participants taking semaglutide received a 2.4 mg dose once a week. After 68 weeks of treatment, the semaglutide group lost an average of 16 percent of baseline body weight, equivalent to 37 pounds, compared with 5.7 percent, 14 pounds for those who were severely assigned behavioral combined with placebo. Significantly higher proportions of participants with semaglutide treatment (75 percent), compared with placebo (27 percent), achieved 10 percent or more weight loss of baseline weight.
“This is a remarkable weight loss, especially for one-third of participants who lost 20 percent of baseline weight, a reduction that continues with a narrow gastrectomy, a bariatric surgery procedure that is being developed. widely used, “Wadden said. “Further research is needed to determine whether patients can sustain these significant losses with long-term use of 2.4 mg semaglutide.”
The greater weight loss achieved with semaglutide than with placebo was associated with greater improvements in cardiometabolic risk factors, including changes in waist circumference, systolic blood pressure, hemoglobin A1c, and triglycerides.
“These metabolic benefits and marked improvements in risk factors offer great promise for the prevention and treatment of diabetes and cardiovascular disease,” said W. Timothy Garvey, MD, study co-author and professor of medicine at in the Department of Nutritional Sciences at the University of Alabama in Birmingham. “The unprecedented level of weight loss is also sufficient to prevent and treat other obesity problems including osteoarthritis, sleep apnea, and non-alcoholic fatty liver disease,” he said.
Gastrointestinal side effects were reported by 83 percent of semaglutide participants and included moderate-to-severe nausea and diarrhea that improved over time, with no need to discontinue the. drug.
Semaglutide is a glucagon-like receptor agonist 1 (GLP-1) that, at a dose of 1.0 mg once weekly, is approved (as Ozempic) by the U.S. Food and Drug Administration for the management of type 2 diabetes. 2. The higher dose of 2.4 mg, currently being evaluated by the FDA for the management of breast weight, appears to affect desire centers in the brain that control hunger and cravings, leading to a reduction in food and calorie. Patients also report feeling full faster when eating. The medication is given once a week by subcutaneous injection.
“The results with semaglutide appear to be at the forefront of weight management that healthcare providers and their obese patients have been waiting for,” Wadden said. “It is clear that adding semaglutide to intensive behavioral therapy could significantly increase the proportions of patients who lose 10 percent or more of their starting weight, with accompanying improvements in health and mobility.”
A question left unanswered by this study is, how much lifestyle counseling is required with semaglutide to lose about 15 percent of baseline weight. Participants with Semaglutide treatment in the STEP 1 trial lost 14.9 percent of initial weight, with 18 sessions of lifestyle counseling, compared with 2.4 percent for placebo.
“For the placebo-treated participants in STEP 3, the 30 intensive behavioral sessions and a food replacement diet seemed to increase weight loss by about 3 percentage points, compared to the less intensive lifestyle counseling provided in the STEP 1 test, ”Wadden noted. “However, no comparative benefit has been observed in combining strict behavioral treatment with semaglutide, suggesting that further study is needed on the optimal lifestyle counseling program required with semaglutide at the higher dose. is currently being evaluated. “
Source:
University of Pennsylvania School of Medicine
Magazine Reference:
Wadden, TA, et al. (2021) Effect of subcutaneous Semaglutide vs. Placebo in association with behavioral intensity on body weight in obese or obese adults The STEP 3 randomized clinical trial. JAMA. doi.org/10.1001/jama.2021.1831.