Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity
- Status
- CompletedResults posted
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 18 Years to no upper limit; no BMI minimum stated; conditions: Obesity
- Interventions
- Semaglutide; Placebo (semaglutide)
- Conditions
- Obesity
- Phase and size
- Phase 3 · 529 participants
- Dates
- Start 2021-03-16
Primary completion 2023-04-18 - Sponsor
- Novo Nordisk A/S (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)From baseline (week 0) to end of treatment (week 52)
- Change in Body WeightFrom baseline (week 0) to end of treatment (week 52)
Published results in the collection
- Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and ObesityRandomized, double-blind, placebo-controlled, parallel-group, multicentre, phase 3 trial; 52-week treatment period · 2023 · Study tier 2 · Different population · Benefit
- Semaglutide and Exercise Function in Obesity-Related HFpEF: Insights From the STEP-HFpEF ProgramRandomized trial · 2025 · Study tier 1 · Different population · Benefit · Unreviewed automatic assessment
- Atrial Fibrillation and Semaglutide Effects in Obesity-Related Heart Failure With Preserved Ejection Fraction: STEP-HFpEF ProgramRandomized trial · 2024 · Study tier 1 · Different population · Benefit · Unreviewed automatic assessment
- Inflammation in Obesity-Related HFpEF: The STEP-HFpEF ProgramRandomized trial · 2024 · Study tier 1 · Different population · Benefit · Unreviewed automatic assessment
- Semaglutide and NYHA Functional Class in Obesity-Related Heart Failure With Preserved Ejection Fraction: The STEP-HFpEF ProgramRandomized trial · 2024 · Study tier 1 · Different population · Benefit · Unreviewed automatic assessment
- Efficacy of Semaglutide by Sex in Obesity-Related Heart Failure With Preserved Ejection Fraction: STEP-HFpEF TrialsRandomized trial · 2024 · Study tier 1 · Different population · Benefit · Unreviewed automatic assessment
- Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trialsRandomized trial · 2024 · Study tier 3 · Different population · Benefit · Partly industry funded · Unreviewed automatic assessment
- Semaglutide in Patients With Obesity and Heart Failure Across Mildly Reduced or Preserved Ejection FractionDesign unknown · 2023 · Not rated · Population unclear · Benefit · Unreviewed automatic assessment
- Effects of Semaglutide on Symptoms, Function, and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction and Obesity: A Prespecified Analysis of the STEP-HFpEF TrialRandomized trial · 2024 · Study tier 2 · Different population · Benefit · Unreviewed automatic assessment
02Eligibility
Who can take part
Inclusion Criteria: * Male or female, age above or equal to 18 years at the time of signing informed consent. * Body mass index (BMI) greater than or equal to 30.0 kg/m\^2 * New York Heart Association (NYHA) Class II-IV * Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at screening Exclusion Criteria: * A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Haemoglobin A1c (HbA1c) greater than or equal to 6.5 percentage (48 mmol/mol) based on latest available value from medical records, no older than 3 months or if unavailable a local measurement at screening
03Change log
Registry changes
No changes recorded since the trial was added.