Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
1
Obesity and Heart Failure with reduced Ejection Fracition
To examine whether weight loss with semaglutide is superior to weight loss with calorie restricted diet in improving the peak oxygen uptake as a marker of physical performance (and with prognostic implications) in patients with obesity and heart failure with reduced EF.
Key facts
- Sponsor
- Region Hovedstaden
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 20 Mar 2024 → ongoing
- Decision date (initial)
- 2024-02-09
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Supported by a grant from Sygeforsikringen Danmark
External identifiers
- EU CT number
- 2023-503753-35-01
- WHO UTN
- U1111-1298-6418
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To examine whether weight loss with semaglutide is superior to weight loss with calorie restricted diet in improving the peak oxygen uptake as a marker of physical performance (and with prognostic implications) in patients with obesity and heart failure with reduced EF.
Secondary objectives 1
- • To examine the effect of a weight loss with either calorie restricted diet or semaglutide on quality of life in patients with obesity and heart failure with reduced EF. • To examine effects of weight loss with either treatment on cardiac metabolism, fibrosis, inflammation, and diastolic function in patients with clinical heart failure. • To examine potentially favorable changes in other organ systems caused by weight loss in this patient group • To examine the feasibility and safety of two modern weight loss programs for aggressive weight lowering in patients with heart failure with reduced ejection fraction.
Conditions and MedDRA coding
Obesity and Heart Failure with reduced Ejection Fracition
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10078289 | Heart failure with reduced ejection fraction | 10007541 |
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | FIT-HF : Effect of weight loss on physical and cardiac performance in obese heart failure patients A randomised, controlled, parallel group trial of the effect of weight loss with either dietary changes or semaglutide in patients with heart failure with reduced ejection fraction
|
Randomised Controlled | None | Low calory diet arm: Treatment with a meal replacement of 800kcal/day for 8 weeks Semaglutide arm: Treatment with semaglutide. Uptitration for 16 weeks with subsequent maintenance therapy for 26 weeks |
Regulatory references
- Scientific advice from competent authorities
- Frederiksberg Hospital
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-503753-35-00 | FIT-HF - Effect of weight loss on physical and cardiac performance in patients with heart failure and obesity | Hvidovre Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Informed 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
- Age>18 years at the time of inclusion
- Body mass index (BMI) ≥ 30 kg/m2
- Have heart failure with reduced ejection fraction (EF<=40%) established by: a. echocardiography b. cardiac magnetic resonance
- Being on stable optimal-medical-heart failure treatment for 4 weeks.
Exclusion criteria 3
- Cardiovascular-related: 1. Any 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 2. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening 3. Presently classified as being in New York Heart Association (NYHA) Class IV heart failure 4. Transient tachycardic induced heart failure
- Glycaemia-related: 5. History of type 1 diabetes 6. Treatment with any GLP-1 RA within 90 days before screening 7. Type 2 diabetes and treatment other than metformin or SGLT-2 inhibitor
- General safety: 8. History or presence of chronic pancreatitis 9. Presence of acute pancreatitis within the past 180 days prior to the day of screening 10. Kidney disease with eGFR<35ml/min 11. Presence 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 12. Severe psychiatric disorder which in the investigator’s opinion could compromise compliance with the protocol 13. Known or suspected hypersensitivity to trial product(s) or related products 14. Previous participation in this trial. Participation is defined as randomisation 15. Receipt of any investigational medicinal product within 30 days before screening 16. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method 17. Any disorder, unwillingness or inability, which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is change in peak oxygen uptake per kg per min (Vo2max) at 52 weeks between groups.
Secondary endpoints 1
- • To compare the effect of weight loss on quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). • To compare the effect of weight loss on the 6MWD • To compare the effect of weight loss on the end-systolic volume assessed by Cardiac MR • To compare the effect of weight loss on the change in biomarkers as high-sensitivity CRP and pro-BNP • Feasibility and safety of a modern weight loss program for weight lowering in high-risk symptomatic patients.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
Wegovy 1.7 mg solution for injection in pre-filled pen
PRD9446838 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.35 mg milligram(s)
- Max total dose
- 2.4 mEq/ml milliequivalent(s)/millilitre
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/004
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 2.4 mg solution for injection in pre-filled pen
PRD9446839 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.35 mg milligram(s)
- Max total dose
- 2.4 mg milligram(s)
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/005
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 1 mg solution for injection in pre-filled pen
PRD9446837 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0.35 mg milligram(s)
- Max total dose
- 2.4 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/003
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 0.25 mg solution for injection in pre-filled pen
PRD9446835 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.35 mg milligram(s)
- Max total dose
- 2.4 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/001
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 0.5 mg solution for injection in pre-filled pen
PRD9446836 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.35 mg milligram(s)
- Max total dose
- 2.4 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/002
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Hovedstaden
- Sponsor organisation
- Region Hovedstaden
- Address
- Kettegaard Alle 30
- City
- Hvidovre
- Postcode
- 2650
- Country
- Denmark
Scientific contact point
- Organisation
- Hvidovre Hospital
- Contact name
- Jens Dahlgaard Hove
Public contact point
- Organisation
- Hvidovre Hospital
- Contact name
- Jens Dahlgaard Hove
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| GCP-enheden ved Københavns Universitetshospital ORL-000002325
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-03-20 | 2024-04-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol CT_2023-503753-35-01 | 3 |
| Protocol (for publication) | D2_Protocol modification nr 1_ CT_2023-503753-35-01 final | 1 |
| Protocol (for publication) | D2_Protocol modification nr 1_ CT_2023-503753-35-01 Track | 1 |
| Protocol (for publication) | D4_EQ-5D-5L questionaire | 1 |
| Protocol (for publication) | D4_KCCQ questionaire | 1 |
| Recruitment arrangements - Extract (for publication) | K1_Recruitement arrangements modification nr 2 CT_2023-503753-35-01 | 3 |
| Recruitment arrangements (for publication) | K1_Recruitement arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitement arrangements - informed contsent | 2 |
| Recruitment arrangements (for publication) | K1_Recruitement arrangements - informed contsent track | 1 |
| Recruitment arrangements (for publication) | K1_Recruitement arrangements modification nr 1 final | 2 |
| Recruitment arrangements (for publication) | K1_Recruitement arrangements modification nr 1 Track | 2 |
| Recruitment arrangements (for publication) | K1_Recruitement arrangements modification nr 2 Track CT_2023-503753-35-01 | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment arrangements - Annonce | 2 |
| Subject information and informed consent form (for publication) | L1_Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Subject information and informed consent form (for publication) | L1_Subject information and consent form | 3 |
| Subject information and informed consent form (for publication) | L1_Subject information modification nr 1 final | 1 |
| Subject information and informed consent form (for publication) | L1_Subject information modification nr 1 Track | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG CT_2023-503753-35-01 | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-29 | Denmark | Acceptable 2024-02-09
|
2024-02-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-10 | Denmark | Acceptable 2024-10-21
|
2024-10-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-21 | Denmark | Acceptable 2025-04-03
|
2025-04-03 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-22 | Denmark | Acceptable 2025-04-03
|
2025-08-22 |