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Randomised controlled trial

Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes

N Engl J MedPublished

  • Randomised controlled trial
  • placebo-controlled
Read the original article ↗

Authors' conclusion

Among patients with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide led to larger reductions in heart failure-related symptoms and physical limitations and greater weight loss than placebo at 1 year.

Study context

Population
Patients with HFpEF, BMI ≥30 and T2DM
Participants
616 patients
Comparison
Semaglutide vs placebo
Primary endpoint
Change from baseline in KCCQ-CSS (0–100, higher = fewer symptoms and physical limitations) and change in body weight
Follow-up
52 weeks

Primary result

As reported in the abstract

Semaglutide

13.7 points

Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS) mean change · Body weight mean % change −9.8%

Placebo

6.4 points

KCCQ-CSS mean change · Body weight mean % change −3.4%

Semaglutide vs PlaceboEstimated difference, points (95% CI)P value
KCCQ-CSS
7.3(4.1–10.4)
P < 0.001
Semaglutide vs PlaceboEstimated difference, percentage points (95% CI)P value
body weight
−6.4(−7.6 to −5.2)
P < 0.001

Secondary outcomes

Outcomeestimated between-group difference (m) (95% CI)P value
Change in 6-minute walk distance (confirmatory secondary)14.3 (3.7–24.9)P = 0.008
Outcomewin ratio (95% CI)P value
Hierarchical composite (death, HF events, KCCQ-CSS and 6-minute walk distance change)1.58 (1.29–1.94)P < 0.001
Outcomeestimated treatment ratio (95% CI)P value
Change in CRP level0.67 (0.55–0.80)P < 0.001

Safety

Serious adverse events

Original publication

Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes. N Engl J Med. Published 6 April 2024. doi:10.1056/nejmoa2313917
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Summarised from the published abstract; every number is checked against it