Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes
- Status
- CompletedResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 18 Years to no upper limit; no BMI minimum stated; conditions: Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2
- Interventions
- Semaglutide; Placebo (Semaglutide)
- Conditions
- Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2
- Phase and size
- Phase 3 · 617 participants
- Dates
- Start 2021-06-15
Primary completion 2023-10-11 - Sponsor
- Novo Nordisk A/S (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary scoreFrom 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 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-Related Heart Failure and Type 2 DiabetesRandomized trial · 2024 · Study tier 2 · Different population · Unclear · Industry funded · 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% at screening * Diagnosed with T2D greater than or equal to 90 days prior to the day of screening * HbA1c of below or equal to 10.0% as measured at the screening visit Exclusion Criteria: * A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
03Change log
Registry changes
No changes recorded since the trial was added.