4 Semaglutide 2.4 mg and Intensive Behavioral Therapy in Subjects With Overweight or Obesity (STEP 3)

Zusammenfassung

In adults with overweight or obesity, semaglutide 2.4 mg as an adjunct to IBT led to significantly greater weight loss and improvements in CVD risk factors and glucose metabolism vs. placebo plus IBT.

Einleitung

Semaglutide, a glucagon-like peptide-1 receptor agonist, has shown clinically relevant weight loss vs. placebo. Studies have shown additive effects of lifestyle interventions in combination with weight loss medication.

Material und Methodik

This 68-week, randomized, double-blind, multicenter, placebo-controlled, phase 3 trial compared the effect on body weight of once-weekly subcutaneous semaglutide 2.4 mg vs. placebo, both as adjunct to low-calorie meal replacement diet for the first 8 weeks and intensive behavioral therapy (IBT; decreased energy intake, increased physical activity, and counseling) for the trial duration in adults with overweight (body mass index [BMI]≥27 kg/m2)+≥1 comorbidity, or obesity (BMI≥30 kg/m2), without type 2 diabetes. Effects on cardiovascular disease (CVD) risk factors, glucose metabolism, patient-reported outcomes, and safety/ tolerability were also assessed.

Ergebnisse

611 randomized subjects (mean age 46 years, body weight 106 kg, BMI 38 kg/m2; 81% female) were included. At week 68, mean body weight decreased from baseline by 16.0% with semaglutide vs. 5.7% with placebo (estimated treatment difference [95% confidence interval]: –10.3 [–12.0, –8.6]; p<0.0001). More subjects achieved weight loss≥5%,≥10%,≥15%, and≥20% with semaglutide vs. placebo (87% vs. 48%; 75% vs. 27%; 56% vs. 13%; 36% vs. 4%, respectively; all p<0.0001). From baseline to week 68, the proportion of subjects with prediabetes decreased from 48% to 7% in the semaglutide group, and from 53% to 26% in the placebo group. Greater improvements were seen with semaglutide in waist circumference, BMI, blood pressure and lipids (total cholesterol, LDL, VLDL, FFA, and triglycerides). No new safety signals with semaglutide were detected; gastrointestinal adverse events were most common (semaglutide: 83%; placebo: 63%).

Publication History

Article published online:
24 September 2021