STEP 3: Weekly semaglutide results in greater weight loss than placebo
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Adults who received a once-weekly 2.4 mg dose of semaglutide in addition to intensive behavioral therapy lost more weight at 68 weeks than those who received placebo, according to trial data presented at ObesityWeek Interactive.
“As adjunct to intensive behavioral therapy, semaglutide 2.4 mg increased weight loss by 10.3 percentage points compared with placebo,” Thomas A. Wadden, PhD, the Albert J. Stunkard professor of psychiatry at the Perelman School of Medicine, University of Pennsylvania, said during a presentation. “This is the largest placebo-subtracted weight loss that I am aware of for a monotherapy for obesity.”
Wadden presented data from STEP 3, a 68-week, randomized, double-blind, placebo-controlled trial in which 611 adults (81% women; mean age, 46 years; 76.1% white) with overweight or obesity who did not have diabetes were randomly assigned to a 2.4 mg dose of semaglutide (Ozempic, Novo Nordisk) once a week or placebo, in addition to intensive behavioral therapy. Participants received an escalating dose of semaglutide or placebo for the first 16 weeks. The 2.4 mg of semaglutide was then administered for 1 year, ending at week 68 of the trial.
Both the semaglutide and placebo groups had the same intensive behavioral therapy program, which consisted of 30 15-minute sessions delivered by a registered dietitian. Participants ate a low-calorie diet for the first 8 weeks, followed by a hypocaloric diet based on body weight at randomization. Physical activity started at 100 minutes of moderate-intensity exercise per week at randomization. Participants were asked to increase their exercise by 25 minutes every 4 weeks, up to a target of 200 minutes per week.
At week 68, the semaglutide cohort lost 10.3 percentage points (16% vs. 5.7%) more weight than the placebo group (95% CI, –12 to –8.6; P < .0001). In the semaglutide group, 75.3% of participants achieved a weight loss of 10% or greater during the trial period compared with 27% for placebo, and 55.8% of those receiving semaglutide had a weight loss of 15% or greater vs. 13.2% for placebo.
The semaglutide group also had a greater improvement in comorbidities compared with placebo, including larger reductions in waist circumference (estimated difference = –14.6 cm; 95% CI, –10.1 to –6.6; P < .0001), HbA1c (estimated difference = –0.24%; 95% CI, –0.29 to –0.19; P < .0001), systolic blood pressure (estimated difference = –3.9 mm Hg; 95% CI, –6.4 to –1.5; P < .01), diastolic BP (estimated difference = –2.2 mm Hg; 95% CI, –3.9 to –0.6; P < .01) and C-reactive protein (estimated difference = –48%; 95% CI, –55 to –39; P < .0001).
Most adverse events in the trial were considered mild. The most common events in the semaglutide cohort were gastrointestinal disorders, including nausea, vomiting, diarrhea and constipation, with 82.8% of participants reporting these symptoms. The semaglutide group had 9.1% of its participants report severe adverse events. Wadden said this rate was driven by gall bladder-related events, as well as issues unrelated to semaglutide. Wadden added that the safety findings for semaglutide 2.4 mg were comparable to those found with semaglutide 1 mg and liraglutide 3 mg (Saxenda, Novo Nordisk).
“These are promising results that show that combining semaglutide 2.4 mg with intensive behavior therapy will help a greater percentage of patients achieve their goal weight, and those larger weight losses will help to improve comorbidities associated with obesity and to improve patients’ quality of life,” Wadden said.
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Wadden TA. Semaglutide 2.4 mg and intensive behavioral therapy in subjects with overweight or obesity (STEP 3). Presented at: ObesityWeek Interactive; Nov. 5, 2020 (virtual meeting).
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