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-HFpEF: semaglutide 2.4 mg for heart failure with obesity
At 52 weeks, the KCCQ-CSS score improved by 16.6 points with semaglutide and 8.7 with placebo (difference of 7.8 points; 95% CI, 4.8 to 10.9), and weight changed by −13.3% versus −2.6% (difference of −10.7 percentage points; 95% CI, −11.9 to −9.4).
Kosiborod MN et al. Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity. New England Journal of Medicine, 2023. DOI: 10.1056/NEJMoa2306963
- Prepared by
- Alex Gonzalez
- Last updated
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- 3 sources
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Key facts
- Drug
- semaglutide
- Design
- Randomized controlled trial
- Participants
- 529
- Duration
- 52 weeks
- Funding
- Novo Nordisk
- Registry
- NCT04788511
- Population
- 529 adults with heart failure with preserved ejection fraction (left ventricular ejection fraction of 45% or more and NYHA class II to IV symptoms) and a BMI of 30 or more, without diabetes (HbA1c below 6.5%), randomized to semaglutide 2.4 mg once weekly (263) or placebo (266); mean age 68 years and 297 women.
- Primary outcome
- Two primary objectives at 52 weeks: the change in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS, from 0 to 100, where more points mean fewer symptoms and physical limitations) and the percentage change in body weight.
What it found
- Semaglutide 2.4 mg weekly−13.3%
- Placebo−2.6%
Difference: −10.7 points vs placebo (95% CI, −11.9 to −9.4).
Figures from the paperSee the results in a chart
At 52 weeks, the KCCQ-CSS score improved by 16.6 points with semaglutide and 8.7 with placebo (difference of 7.8 points; 95% CI, 4.8 to 10.9), and weight changed by −13.3% versus −2.6% (difference of −10.7 percentage points; 95% CI, −11.9 to −9.4). The distance covered in the 6-minute walk test increased by 21.5 m with semaglutide and 1.2 m with placebo (difference of 20.3 m; 95% CI, 8.6 to 32.1). C-reactive protein, a marker of inflammation, fell by 43.5% with semaglutide and 7.3% with placebo. Serious adverse events occurred in 13.3% on semaglutide and 26.7% on placebo.
Limitations
Funded by Novo Nordisk. It lasted 52 weeks and, with 529 participants, it does not allow conclusions about deaths or hospitalizations for heart failure. The improvement in symptoms is measured with a questionnaire that participants fill in themselves. People with diabetes were excluded. According to the trial registry, the results use the data of everyone randomized for as long as they stayed in the trial, whether or not they had stopped treatment.
What it means for you
In people with heart failure with preserved ejection fraction and obesity, semaglutide 2.4 mg (the Wegovy dose) improved symptoms, walking distance and weight (13.3% on average) over 52 weeks compared with placebo. The trial does not show that it reduces deaths or hospital admissions. If you have heart failure, any change to your treatment should be decided by your cardiologist or 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/10.1056/NEJMoa2306963
Sources
The original paper and the records consulted for this summary, with the date they were accessed.
- New England Journal of Medicine.Kosiborod MN, et al. Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity. N Engl J Med. 2023;389(12):1069-1084.accessed .
- National Library of Medicine (PubMed).PubMed record PMID 37622681 (abstract).accessed .
- ClinicalTrials.gov (National Library of Medicine).ClinicalTrials.gov record NCT04788511 (eligibility, arm sizes, baseline and analysis period).accessed .