Trial results for the STEP UP study (NCT05646706) investigating semaglutide for people with obesity were posted on ClinicalTrials.gov on 2026-04-23. The Phase 3 study showed that participants receiving semaglutide 7.2 mg achieved a mean body weight reduction of -19.5%, compared to -3.8% for those on placebo.
Background
The STEP UP study, also known as "A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight," aimed to evaluate the efficacy of semaglutide in individuals with obesity. The study compared an investigational dose of semaglutide to a placebo for weight loss.
Trial design
The STEP UP study (NCT05646706) was a Phase 3, randomized, placebo-controlled trial that enrolled 1407 participants. The study investigated semaglutide in people diagnosed with obesity. Participants were randomly assigned to receive either semaglutide or placebo, in addition to lifestyle counseling on healthy food choices and physical activity.
Key results
The trial results demonstrated significant differences in weight reduction between the semaglutide 7.2 mg and placebo groups. For the outcome of "Relative Change in Body Weight":
- Participants receiving semaglutide 7.2 mg achieved a mean body weight reduction of -19.5% (Standard Deviation: 10.6).
- Participants receiving placebo achieved a mean body weight reduction of -3.8% (Standard Deviation: 7.1).
An ANCOVA analysis showed a treatment difference of -14.81% (95.0% CI: -16.21 to -13.41) with a p-value of 0.0001.
Regarding the proportion of participants achieving specific weight loss thresholds:
- Weight loss ≥ 5%: 862 participants in the semaglutide 7.2 mg group achieved this, compared to 63 in the placebo group.
- Weight loss ≥ 10%: 783 participants in the semaglutide 7.2 mg group achieved this, compared to 35 in the placebo group.
- Weight loss ≥ 15%: 632 participants in the semaglutide 7.2 mg group achieved this, compared to 13 in the placebo group.
A binary regression model for achieving weight loss ≥ 5% showed an Odds Ratio (OR) of 12.1 (95.0% CI: 8.32 to 17.61) with a p-value of 0.0001.
What this means
The results from the STEP UP trial indicate that semaglutide 7.2 mg significantly reduced body weight in individuals with obesity compared to placebo. The substantial mean percentage change in body weight and the higher proportion of participants achieving clinically meaningful weight loss thresholds (≥5%, ≥10%, ≥15%) suggest that this dose of semaglutide could be a highly effective therapeutic option for weight management in this population. These findings provide important data for clinicians considering treatment strategies for obesity.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05646706, titled "A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)," were posted on 2026-04-23 on clinicaltrials.gov.