Research study to investigate how well semaglutide works in people living with obesity and heart failure

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; MedDRA version: 20.1Level: LLTClassification code 10076396Term: Heart failure with preserved ejection fractionSystem Organ Class: 100000004849; Heart failure with preserved ejection fractionObesity

• Registration Number: EUCTR2019-004452-11-HU
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-20
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 516

Inclusion Criteria

- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Body mass index (BMI) equal to or above 30.0 kg/m^2
- New York Heart Association (NYHA) Class II-IV
- Left ventricular ejection fraction (LVEF) equal to or above 45 % at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 258
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 258

Exclusion Criteria

- A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- Glycated haemoglobin A1c (HbA1c) equal to or above 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effects of 2.4 mg semaglutide administered subcutaneously (s.c. under the skin) once-weekly on physical function, symptoms and body weight compared with placebo, both added to standard of care, in subjects with obesity related heart failure with preserved ejection fraction (HFpEF);Secondary Objective: To investigate the effects of semaglutide s.c. 2.4 mg once-weekly on walking distance, biomarker of inflammation, body composition, disease specific aspects, social limitation, and health-related quality of life compared with placebo, both added to standard of care, in subjects with obesity related HFpEF.;Primary end point(s): 1. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score <br>2. Change in body weight;Timepoint(s) of evaluation of this end point: 1.-2. From baseline (week 0) to end of treatment (week 52)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change in C-Reactive Protein (CRP) <br>2. Change in 6 minutes walking distance <br>3. Subject achieving 10 % weight loss or more (Yes/No)<br>4. Subject achieving 15 % weight loss or more (Yes/No)<br>5. Subject improving 5 points or more in KCCQ clinical summary score (Yes/No)<br>6. Subject improving 10 points or more in KCCQ clinical summary score (Yes/No)<br>7. Change in KCCQ overall summary score <br>8. Change in systolic blood pressure (SBP) <br>9. Change in waist circumference;Timepoint(s) of evaluation of this end point: 1. From baseline (week -2) to end of treatment (week 52)<br>2. – 7. From baseline (week 0) to end of treatment (week 52)<br>8. From baseline (week -2) to end of treatment (week 52)<br>9. From baseline (week 0) to end of treatment (week 52)