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OpenTrials
Completed

NCT Number: NCT04916470

Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes

This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight.

This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms.

Participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance.

Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm.

During the study participants will have talks with the study staff about healthy lifestyle and physical activity.

The study will last for about 59 weeks, that is a little more than 1 year. Participants will have 12 clinic visits with the study doctor.

* At 6 of the visits participants will have blood samples taken. * At 5 of the visits participants will be asked to fill in a questionnaire * At 4 of the visits participants will have to do a 6-minute walking test * At 3 of the visits participants will have a test to check the heart. * participants will have their eyes checked before or at the start of the study and at the end of the study

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CEMEDIC, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

semaglutide

Drug

Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly for 52 weeks. Dose will be gradually increased to 2.4 mg: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 52.

Placebo (semaglutide)

Drug

Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly for 52 weeks.

Primary outcomes

  1. Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score

    Time frame: From baseline (week 0) to end of treatment (week 52)

    Score on a scale of 0 to 100 where the score 100 means the least burden for the participant.

  2. Change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 52)

    Percentage (%)

Secondary outcomes

  1. Change in 6-minute walking distance

    Time frame: From baseline (week 0) to end of treatment (week 52)

    Measured in metres

  2. Hierarchical composite of time to all-cause death

    Time frame: From baseline (week 0) to end of study (week 57)

    Measured as total wins for each treatment group.

  3. Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit

    Time frame: From baseline (week 0) to end of study (week 57)

    Measured as total wins for each treatment group

  4. Hierarchical composite of time to first heart failure event requiring hospitalisation or urgent heart failure visit

    Time frame: From baseline (week 0) to end of study (week 57)

    Measured as total wins for each treatment group.

  5. Hierarchical composite of difference at least 15 inKansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score change from baseline to 52 weeks

    Time frame: From baseline (week 0) to end of study (week 57)

    Measured as total wins for each treatment group.

  6. Hierarchical composite of difference at least 10 in KCCQ clinical summary score change from baseline to 52 weeks

    Time frame: From baseline (week 0) to end of study (week 57)

    Measured as total wins for each treatment group.

  7. Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 52 weeks

    Time frame: From baseline (week 0) to end of study (week 57)

    Measured as total wins for each treatment group.

  8. Hierarchical composite of difference at least 30 metres in six-minute walking distance change from baseline to 52 weeks (assessed by the win ratio)

    Time frame: From baseline (week 0) to end of study (week 57)

    Measured as total wins for each treatment group.

  9. Change in C-Reactive Protein

    Time frame: From baseline (week -2) to end of treatment (week 52)

    Presented as ratio to baseline

  10. Participant achieving 10% weight loss or more (Yes/No)

    Time frame: From baseline (week 0) to end of treatment (week 52)

    Count of participants

  11. Participant achieving 15% weight loss or more (Yes/No)

    Time frame: From baseline (week 0) to end of treatment (week 52)

    Count of participants

  12. Participant achieving 20% weight loss or more (Yes/No)

    Time frame: From baseline (week 0) to end of treatment (week 52)

    Count of participants

  13. Participant improving 5 points or more in KCCQ clinical summary score

    Time frame: From baseline (week 0) to end of treatment (week 52)

    Count of participants

  14. Participant improving 10 points or more in KCCQ clinical summary score (Yes/No)

    Time frame: From baseline (week 0) to end of treatment (week 52)

    Count of participants

  15. Change in KCCQ overall summary score

    Time frame: From baseline (week 0) to end of treatment (week 52)

    Score on a scale of 0 to 100 where the score 100 means the least burden for the participant.

  16. Participant achieving threshold for clinically meaningful within-subject change in KCCQ-CSS

    Time frame: From baseline (week 0) to end of treatment (week 52)

    Count of participants

  17. Participant achieving threshold for clinically meaningful within-subject change in 6MWD

    Time frame: From baseline (week 0) to end of treatment (week 52)

    Count of participants

  18. Change in waist circumference

    Time frame: From baseline (week 0) to end of treatment (visit 52)

    Measured in centimetre (cm)

  19. Change in systolic blood pressure

    Time frame: From baseline (week -2) to end of treatment (week 52)

    Measured in millimetre of mercury (mmHg)

  20. Change in glycated haemoglobin (HbA1c)

    Time frame: From baseline (week 0) to end of treatment (week 52)

    Measured in percentage (%)-point

  21. Number of treatment emergent severe or clinically significant hypoglycaemia episodes

    Time frame: From baseline (week 0) to end of trial (week 57)

    Count of events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Effect of Semaglutide 2.4 mg Once-weekly on Function and Symptoms in Subjects With Obesity-related Heart Failure With Preserved Ejection Fraction, and Type 2 Diabetes

Acronym: STEP HFpEF DM

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 7, 2021
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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