Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial
Weight loss proves to be beneficial for patients with diabetes. A combination of lifestyle intervention, behavioral modifications and pharmacotherapy helps improve various cardio-metabolic risk factors in individuals with overweight and obesity. GLP-1 receptors are used in individuals with diabetes to aid weight loss. Thomas A. Wadden and colleagues thereby conducted a research titled “Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial” and the summary has been given below.
Objective
To analyse the effect of once-a-week subcutaneous semaglutide at a dosage of 2.4 mg vs placebo for weight management as a supplementary aid to behaviour modifications and low-calorie diet in adults having excessive weight.
Method
The study was a randomized double-blind, parallel group, 68-week, phase 3a study in 41 sites across USA where adults who had a BMI higher than 27 kg/m2 and a comorbidity. The participants were arbitrarily allocated (2:1) to a dose of 2.4 mg of semaglutide and a combination of low-calorie diet for the initial 8 weeks and 30 counselling sessions in a period of 68 weeks. 5 % and greater reduction in baseline weight was observed as the prime outcome.
Findings
The weight loss achieved was significantly higher on semaglutide. Besides, an improvement in various profiles such as those of BMI, diastolic blood pressure, levels of CRP, lipid profile and HBA1c were observed. Certain adverse events reported included nausea, vomiting and constipation with most of the participants getting better without stopping treatment. Patients on semaglutide also reported less hunger, cravings and decreased energy intake compared to placebo. These findings propose that the incorporation of intensive therapy in addition to an 8-week low-calorie diet may not add onto weight reduction beyond the level achieved by semaglutide and less-intensive lifestyle modifications. Additional research is needed to establish the lifestyle changes required with 2.4 mg of semaglutide dosage.
Limitations
It could not establish the separate contributions to weight reduction of intensive behavioral therapy and the low-calorie diet in the placebo group or as aforementioned, determine the advantage of combining the interventions with semaglutide. Secondly, it was a short trial that did not inscribe whether participants treated with semaglutide would sustain the weight loss if they continued to receive the medication beyond the allocated time span. Additional research is required of the acceptability to the patients of an injectable prescription for corpulence compared with the customary oral delivery
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