Research study to look at how well semaglutide works in people living with heart failure, obesity and type 2 diabetes

Phase 1

• Conditions: Heart failure with preserved ejection fractionDiabetes Mellitus, type 2; 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: EUCTR2020-004170-22-PL
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-16
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 610

Inclusion Criteria

- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Body mass index (BMI) at least 30.0 kg/m^2
- New York Heart Association (NYHA) Class II-IV
- Left ventricular ejection fraction (LVEF) at least 45% at screening
- Diagnosed with T2D at least 90 days prior to the day of screening
- HbA1c of maximum 10.0% as measured at the screening visit
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 305
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 305

Exclusion Criteria

- A self-reported change in body weight more 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.

Study & Design

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