Effect of semaglutide 2.4 mg once weekly on function and symptoms in subjects with obesity-related heart failure with preserved ejection fraction.

Effect of semaglutide 2.4 mg once weekly on function and symptoms in subjects with obesity-related heart failure with preserved ejection fraction. - STEP HFpEF

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51952

Enrollment

Registered

2020-12-02

Start date

2021-04-20

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesitas heartfailure obesity

Interventions

Once weekly semaglutide/placebo subcuteneous injection, dose 2.4 mg.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Male or female, age above or equal to 18 years at the time of signing informed consent. • Body mass index (BMI) >= 30.0 kg/m2 • New York Heart Association (NYHA) Class II-IV • Left ventricular ejection fraction (LVEF) >= 45 % at screening

Exclusion criteria

Exclusion criteria: • A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records • Haemoglobin A1c (HbA1c) >= 6.5 % (48 mmol/mol) based on latest available value from medical records, no older than 3 months or if unavailable a local measurement at screening

Design outcomes

Primary

Measure	Time frame
The primary endpoints are change in KCCQ (clinical summary score) and change in body weight from baseline to end of treatment.	—

Secondary

Measure	Time frame
The secondary endpoints are change in C-Reactive Protein (CRP) and change in six-minute walking distance from baseline to end of treatment. Hierarchical composite of: - Time to all-cause death, number of heart failure events requiring hospitalisation or urgent heart failure visit, - time to first heart failure event requiring hospitalisation or urgent heart failure visit, - difference at least 15 in KCCQ clinical summary score change from baseline to 52 weeks, - difference at least 10 in KCCQ clinical summary score change from baseline to 52 weeks, - difference at least 5 in KCCQ clinical summary score change from baseline to 52 weeks, - difference at least 30 metres in sixminute walking distance change from baseline to 52 weeks (assessed by the win ratio)	—

Measure

Time frame

The secondary endpoints are change in C-Reactive Protein (CRP) and change in six-minute walking distance from baseline to end of treatment. Hierarchical composite of: - Time to all-cause death, number of heart failure events requiring hospitalisation or urgent heart failure visit, - time to first heart failure event requiring hospitalisation or urgent heart failure visit, - difference at least 15 in KCCQ clinical summary score change from baseline to 52 weeks, - difference at least 10 in KCCQ clinical summary score change from baseline to 52 weeks, - difference at least 5 in KCCQ clinical summary score change from baseline to 52 weeks, - difference at least 30 metres in sixminute walking distance change from baseline to 52 weeks (assessed by the win ratio)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)