Summary:
In adults aged 18 or older with obesity and prediabetes, once-weekly subcutaneous semaglutide 2.4 mg combined with diet and physical activity counselling significantly reduced bodyweight (-13.9% vs. -2.7%) and increased reversion to normoglycaemia (81% vs. 14%) compared to placebo with the same lifestyle counselling, though it was associated with a higher rate of treatment discontinuation due to adverse events (6% vs. 1%).
PICO | Description |
---|---|
Population | Adults aged 18 or older with obesity (BMI ≥30 kg/m2) and prediabetes (defined as HbA1c of 6.0–6.4% or fasting plasma glucose of 5.5–6.9 mmol/L), who were part of a 52-week multicentre phase 3 trial involving 207 participants (71% female, 29% male, and 88% White). |
Intervention | Once-weekly subcutaneous semaglutide 2.4 mg combined with diet and physical activity counselling over 52 weeks, followed by a 28-week off-treatment period. |
Comparison | Placebo combined with the same diet and physical activity counselling over the same treatment and off-treatment periods. |
Outcome | Semaglutide led to significantly greater reductions in bodyweight (-13.9%, SD 0.7 vs. -2.7%, SD 0.6; p<0.0001) and higher rates of reversion to normoglycaemia (81% vs. 14%, odds ratio 19.8; p<0.0001). The safety profile was consistent with prior studies, with no new safety signals. Serious adverse events were reported in 9% of both groups, and adverse events leading to discontinuation were more common with semaglutide (6% vs. 1%). |
Source: Wilding, John P. H., et al. “Efficacy and safety of once-weekly semaglutide 2·4 mg versus placebo in people with obesity and prediabetes (STEP 10): a randomised, double-blind, placebo-controlled, multicentre phase 3 trial.” The Lancet Diabetes & Endocrinology. Read article here.