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

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-12
• Last Update Posted: 30 May 2022

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