A late-breaking abstract was released today on a study in which patients were given a higher dose (2.4 mg) of semaglutide than is currently approved for weight management. Semaglutide, a GLP-1 analog drug approved at a higher dose (2mg) in March for type 2 diabetes, only received approval to treat obesity last year.
In the STEP 1 trial, 1,961 patients began a diet and physical activity regimen while half were randomized to receive semaglutide 2.4 mg weekly and half to placebo. At 68 weeks, patients on semaglutide saw a 16.9% weight loss compared to 2.4% weight loss for placebo.
In STEP 4, all 803 patients did the diet and exercise regimen while receiving semaglutide for the first 20 weeks, during which they had an average 10.6% weight loss. When then randomized to continue semaglutide or receive placebo through week 68, the semaglutide group lost another 8.8% while the placebo group regained 6.5%.
The studies’ aim was to assess the Cardiometabolic Disease Staging (CMDS) score, a validated predictor of patients’ 10-year risk of developing type 2 diabetes, in both trials. At baseline in STEP 1, scores were similar in the semaglutide (18.2% risk) and placebo (17.8%) groups, but at week 68, the semaglutide group dropped to 7.1% while placebo only fell to 15.6%. In STEP 4, all participants had a baseline 20.6% score that was cut in half by week 20. At week 68, however, the semaglutide group continued the decrease, from 11.4% at 20 weeks to 7.7%, while the placebo group lost its gains, climbing from 10.7% at 20 weeks to 15.4%.
The semaglutide benefits were similar whether patients had normal glucose levels at baseline (CMDS fell from 15.5% to 6.3%) or had prediabetes (22.4% to 8.3%).
Across all participants in both trials, patients taking semaglutide 2.4mg over 68 weeks experienced an approximately 50%-57% greater reduction in CMDS scores than patients on placebo.
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