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In February 2021, a clinical trial (STEP 1) evaluating the efficacy and safety of sommarlutide compared with placebo as an adjunctive to a lifestyle intervention for the treatment of obese patients or overweight individuals with cardiovascular risk factors showed that sommarlutide has a very good weight loss effect.
STEP 1 is a randomized, double-blind, placebo-controlled clinical trial conducted at 129 sites in 16 countries and territories in Asia, Europe, North America, and South America. Researchers recruited 1,961 overweight or obese adults (18 years of age or older) without diabetes who had failed to lose weight through one or more self-reported dietary approaches. Subjects were randomly assigned to the treatment group (n=1,306) or the control group (n=655) in a ratio of 2:1. The treatment group received subcutaneous injection of 2.4 mg of sommarlutide once a week, while the control group received subcutaneous injection of placebo. The trial lasted for 68 weeks. All participants received a lifestyle intervention. The primary endpoints were percentage change in body weight and the proportion of participants who lost at least 5% of their body weight.
The results found that the average weight loss from baseline to week 68 was 14.9% in the sommarlutide group versus 2.4% in the control group, a treatment difference of 12.4 percentage points (P<0.001). 1047 (86.4%), 838 (69.1%) and 612 (50.5%) people in the somarutide group lost 5%, 10% and 15% of their body weight, respectively, compared with 182 (31.5%), 69 (12.0%) and 28 (4.9%) in the control group. The mean weight loss in the somarlutide group was 15.3 kg compared to 2.6 kg in the control group, with a treatment difference of 12.7 kg. Compared with the control group, the somarlutide group showed greater improvement in both cardiovascular and metabolic risk factors and physical function.
The most common adverse effects in the somarlutide group were nausea and diarrhea, but these adverse effects were usually transient, mild to moderate, and resolved over time. There were more terminations due to gastrointestinal events in the somarlutide group than in the control group, 59 (4.5%) versus 5 (0.8%).
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