A Phase 2, double-blind, dose-ranging, 52-week trial of 957 obese individuals without diabetes found that once-daily subcutaneous (SC) injection of semaglutide 0.4mg resulted in 83% of participants losing ≥5% of their body weight vs 23% with placebo and 66% with the active control. The full findings were presented at the Endocrine Society’s annual meeting (ENDO) in Chicago.
Semaglutide (Ozempic; Novo Nordisk), a GLP-1 receptor agonist, is approved as an adjunct to diet and exercise to treat type 2 diabetes. This trial investigated once-daily semaglutide 0.05mg, 0.1mg, 0.2mg, 0.3mg or 0.4mg (starting at 0.05mg and escalating every 4 weeks to target dose). Liraglutide 3mg was administered as an active control.
Mean weight of participants at baseline was 111kg (70–244) and BMI was 39kg/m2 (30–80). The primary endpoint was change in body weight (%) from baseline; secondary endpoints included percentage of adults achieving weight loss of ≥5% and ≥10%, change in body weight, HbA1c, and fasting plasma glucose from baseline.
Results showed that the estimated mean weight losses from baseline to Week 52 were -2.3% (placebo) and -7.8% (liraglutide 3mg) compared with -6.0% (0.05mg; P=0.001), -8.6% (0.1mg), -11.6% (0.2mg), -11.2% (0.3mg) and -13.8% (0.4mg; P<0.0001).
Weight loss ≥5% for the semaglutide group occurred in an estimated 54% (0.05mg), 67% (0.1mg), 75% (0.2mg), 81% (0.3mg), and 83% (0.4mg) of subjects (all P<0.0001 vs placebo), compared with 23% for placebo and 66% for liraglutide. Weight loss ≥10% for the semaglutide group occurred in an estimated 19% (0.05mg), 37% (0.1mg), 56% (0.2mg), 58% (0.3mg), and 65% (0.4mg) of subjects (P<0.0001), compared with 10% for placebo and 34% for liraglutide.
The most common adverse events in the semaglutide group were dose-related gastrointestinal events as seen previously with GLP-1 receptor agonists.
Lead author Patrick M. O’Neil, PhD, stated, “In conclusion, in combination with dietary and physical activity counseling, all SEMA doses from 0.05 to 0.4 mg daily were tolerated and resulted in dose-related reductions in body weight that were superior to PBO among people with obesity without diabetes.” A Phase 3 trial is being planned for later this year to evaluate semaglutide in 4,500 individuals who are overweight or obese.
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