SEMAGLUTIDE for Obesity|Heart failure with reduced ejection fraction

Inclusion criteria

• {"criterion_text":"- 1.\tInformed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial\n- 2.\tAge>18 years at the time of inclusion\n- 3.\tBody mass index (BMI) ≥ 30 kg/m2\n- 4.\tHave heart failure with reduced ejection fraction (EF<=40%) established by: a.\techocardiography b.\tcardiac magnetic resonance\n- 5.\tBeing on stable optimal-medical-heart failure treatment for 4 weeks."}

Exclusion criteria

• {"criterion_text":"- Cardiovascular-related: 1.\tAny of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening\n- 2.\tPlanned coronary, carotid or peripheral artery revascularisation known on the day of screening\n- 3.\tPresently classified as being in New York Heart Association (NYHA) Class IV heart failure\n- 4.\tTransient tachycardic induced heart failure\n- Glycaemia-related: 5.\tHistory of type 1 diabetes\n- 6.\tTreatment with any GLP-1 RA within 90 days before screening\n- 7.\tType 2 diabetes and treatment other than metformin or SGLT-2 inhibitor\n- General safety: 8.\tHistory or presence of chronic pancreatitis\n- 9.\tPresence of acute pancreatitis within the past 180 days prior to the day of screening\n- 10.\tKidney disease with eGFR<35ml/min\n- 11.\tPresence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed\n- 12.\tSevere psychiatric disorder which in the investigator’s opinion could compromise compliance with the protocol\n- 13.\tKnown or suspected hypersensitivity to trial product(s) or related products\n- 14.\tPrevious participation in this trial. Participation is defined as randomisation\n- 15.\tReceipt of any investigational medicinal product within 30 days before screening\n- 16.\tFemale who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method\n- 17.\tAny disorder, unwillingness or inability, which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is change in peak oxygen uptake per kg per min (Vo2max) at 52 weeks between groups.","definition_or_measurement_approach":"Change in peak oxygen uptake per kg per min (Vo2max) measured at 52 weeks between treatment groups."}

Secondary endpoints

• {"endpoint_text":"- To compare the effect of weight loss on quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ).\n- To compare the effect of weight loss on the 6MWD\n- To compare the effect of weight loss on the end-systolic volume assessed by Cardiac MR\n- To compare the effect of weight loss on the change in biomarkers as high-sensitivity CRP and pro-BNP\n- Feasibility and safety of a modern weight loss program for weight lowering in high-risk symptomatic patients.","definition_or_measurement_approach":"Quality of life: Kansas City Cardiomyopathy Questionnaire (KCCQ). 6MWD: six-minute walk distance measured in metres. End-systolic volume: assessed by cardiac magnetic resonance imaging. Biomarkers: changes in high-sensitivity CRP and pro-BNP. Feasibility and safety: protocol-defined safety and feasibility assessments."}

Denmark

Earliest CTIS Part Ii Submission Date

26-01-2024

Latest Decision Or Authorization Date

22-08-2025

Processing Time Days

574

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Region Hovedstaden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Health care"}