semaglutide · 72 weeks
STEP UP
At 72 weeks, weight changed by −18.7% with semaglutide 7.2 mg, −15.6% with 2.4 mg and −3.9% with placebo.
Randomized controlled trial
STEP 5: two years of semaglutide 2.4 mg (Wegovy) for obesity
At 104 weeks, weight changed by −15.2% with semaglutide 2.4 mg and −2.6% with placebo; the estimated difference was −12.6 percentage points (95% CI, −15.3 to −9.8).
Garvey WT et al. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nature Medicine, 2022. DOI: 10.1038/s41591-022-02026-4
- Prepared by
- Alex Gonzalez
- Last updated
- Sources
- 3 sources
No clinical review. No advertising from drug companies and no affiliate links.How we work
Key facts
- Drug
- semaglutide
- Design
- Randomized controlled trial
- Participants
- 304
- Duration
- 104 weeks
- Funding
- Novo Nordisk
- Registry
- NCT03693430
- Population
- 304 adults with obesity, or overweight with at least one weight-related comorbidity, without diabetes, at 41 sites in five countries (Canada, Hungary, Italy, Spain and the United States), randomized to semaglutide 2.4 mg once weekly (152) or placebo (152); 77.6% women, mean age 47.3 years, mean BMI 38.5 and mean weight 106.0 kg.
- Primary outcome
- Percentage change in body weight and proportion of participants who lost at least 5% of their weight at 104 weeks (two years) with semaglutide 2.4 mg once weekly versus placebo, both with a behavioral intervention.
What it found
- Semaglutide 2.4 mg weekly−15.2%
- Placebo−2.6%
Difference: −12.6 points vs placebo (95% CI, −15.3 to −9.8).
Figures from the paperSee the results in a chart
At 104 weeks, weight changed by −15.2% with semaglutide 2.4 mg and −2.6% with placebo; the estimated difference was −12.6 percentage points (95% CI, −15.3 to −9.8). Of the participants on semaglutide, 77.1% lost at least 5% of their weight, compared with 34.4% on placebo. The main analysis included everyone who was randomized, whether or not they stopped treatment or received another intervention (treatment-policy estimand), and 92.8% completed the trial. Digestive adverse effects, mostly mild or moderate, were more frequent with semaglutide (82.2% versus 53.9%).
Limitations
Funded by Novo Nordisk, which designed the trial, oversaw its conduct and collected and analyzed the data. Small sample (304 participants), mostly women and mostly white (93.1%). People with diabetes were excluded. All participants received a behavioral intervention. It does not report what happens when the drug is stopped after the two years.
What it means for you
STEP 5 followed people with obesity without diabetes for two years: on weekly semaglutide 2.4 mg (the Wegovy dose), average weight loss was 15.2% at 104 weeks and it held for as long as treatment continued. It is a small trial, and an average does not predict any one person’s result. If you wonder how long the effect lasts, these figures are a good starting point for a conversation with your doctor.
Further reading
- How Much Weight Do People Lose on Ozempic, Wegovy or Zepbound? Trial Data
- Ozempic vs Mounjaro (and Zepbound): Real Differences From the Trials and Labels
- What Happens When You Stop Ozempic, Wegovy or Zepbound: Weight Regain, Explained
- GLP-1 drug pages
- All study summaries
- Original paper: doi.org/10.1038/s41591-022-02026-4
Sources
The original paper and the records consulted for this summary, with the date they were accessed.
- Nature Medicine.Garvey WT, et al. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022;28(10):2083-2091.accessed .
- National Library of Medicine (PubMed).PubMed record PMID 36216945 (abstract).accessed .
- PubMed Central (National Library of Medicine).Full text PMC9556320 (sites, estimands and funding).accessed .