Garvey WT, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jódar E, Kandler K, Rigas G, Wadden TA, Wharton S; STEP 5 Study Group. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022 Oct;28(10):2083-2091. doi: 10.1038/s41591-022-02026-4. Epub 2022 Oct 10. PMID: 36216945; PMCID: PMC9556320.
Highlights:
- A review and meta-analysis of the scientific literature, involving a total of 3,613 individuals with obesity without diabetes, split into a treatment group receiving Semaglutide and a placebo group
- The group that received Semaglutide showed a weight reduction of 11.85% over the placebo group.
- However, the Semaglutide group showed that gastrointestinal adverse events were more 1.59 times more likely compared to placebo.
Result:
From 5 October 2018 to 1 February 2019, 304 participants were randomly assigned to semaglutide 2.4 mg (n = 152) or placebo (n = 152) and included in the full analysis set (all randomized participants according to the intention-to-treat principle). Observation periods included the in-trial period (that is, while in the trial, regardless of treatment discontinuation or rescue intervention) and the on-treatment period (with trial product). Overall, of 304 participants, 282 (92.8%) completed the trial (attended the end-of-trial safety visit), 272 (89.5%) had a body weight assessment at the end-of-treatment visit at week 104, and 243 (79.9%) adhered to treatment (were on-treatment at the end-of-treatment visit.
Demographics and baseline characteristics were similar between groups (Table (Table1).1). Most participants were female (236 (77.6%) of 304) and most were white (283 (93.1%) of 304). Mean age was 47.3 years. Mean body weight was 106.0 kg and mean BMI was 38.5 kg m–2.
Conclusion:
In summary, in adults with overweight (with at least one weight-related comorbidity) or obesity, semaglutide treatment led to substantial, sustained weight loss over 104 weeks versus placebo.
