← Trials/Trial dossier/NCT06423599

FIT-HF

RecruitingPhase 2, PHASE3

Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure

Lead sponsor

Jens D Hove, MD,PHD

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

100

estimated

Study population

Heart failure, Obesity / overweight

Key I/E criteria

•BMI ≥30•EF ≤40%

Primary endpoint

•Peak oxygen uptake

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06423599

Org study IDU1111-1298-6418

Secondary ID2023-503753-35-01

Timeline

Milestones

Study start2024-05-17actual

Study first posted2024-05-21actual

Last update posted2024-05-24actual

Primary completion2026-06-30estimated

Study completion2026-12-30estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Heart failureObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, age ≥ 18 years at the time of signing informed consent

•Body mass index (BMI) ≥ 30 kg/m2

•Heart failure with New York Heart Association (NYHA)-class 1-3 and reduced ejection fraction (EF≤40%) established by either:

1. echocardiography AND/OR

2. cardiac magnetic resonance

•On stable optimal medical heart failure therapy for at least 4 weeks

Exclusion criteria

1. Cardiovascular-related:

–Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 6 months prior to the day of screening

–Planned coronary, carotid or peripheral artery revascularisation known on the day of screening

–Transient heart failure related to reversible mechanisms like tachycardia, sepsis, etc.

2. Glycaemia-related:

–Type 1 diabetes

–Treatment with any Glucagon-Like Peptide-1 (GLP-1) agonists within 90 days prior to the day of screening

–Type 2 diabetes requiring other pharmacotherapy than metformin and Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

3. General safety:

–Pregnancy or planned pregnancy

–History or presence of chronic pancreatitis

–Presence of acute pancreatitis within the past 180 days prior to the day of screening

–Kidney disease with eGFR < 35ml/min

–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)

–Known or suspected hypersensitivity to trial product(s) or related products

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Heart failure

Cardiovascular outcomes

Other (unclassified)

Patient-reported / QoL

Safety / tolerability / PK

Cardiovascular outcomes

5 endpoints

Other/protocol endpoint

Composite endpoint consisting of all-cause death, non-fatal myocardial infarction, non-fatal stroke, heart failure hospitalisation or urgent heart failure visit

Time frame:Follow-up at 52 weeks

5-point MACE

composite event, event

componentsAll-cause death, Non-fatal MI, Non-fatal stroke, Heart-failure hospitalization, Urgent heart-failure visit

Other/protocol endpoint

First occurrence of a composite heart failure endpoint consisting of: heart failure hospitalisation, urgent heart failure visit, ischemic events or CV death

Time frame:Follow-up at 52 weeks

Expanded / custom MACE composite

time to event, event

componentsHeart-failure hospitalization, Urgent heart-failure visit, CV events (total recurrent), Cardiovascular death

Other/protocol endpoint

All-cause death

Time frame:Follow-up at 52 weeks

All-cause death

time to event, event

SNOMED 419620001

Other/protocol endpoint

Total number of hospitalised days

Time frame:Follow-up at 52 weeks

event count, event

Other/protocol endpoint

Total number of hospitalisations

Time frame:Follow-up at 52 weeks

All-cause hospitalization

event count, event

Heart failure

6 endpoints

Primary/protocol endpoint

Peak oxygen uptake

Time frame:The patients will be examined after 0, 16 and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

The Clinical Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-CSS)

Time frame:The patients will be examined after 0, 16 and 52 weeks.

KCCQ clinical summary

change from baseline, improvement

Secondary/protocol endpoint

6-min walk distance (6MWD)

Time frame:The patients will be examined after 0, 16 and 52 weeks

6-minute walk distance

change from baseline, improvement

Secondary/protocol endpoint/low confidence

End-systolic volume of the left ventricle assessed by Cardiac MRI

Time frame:The patients will be examined after 0, 16 and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

N-terminal pro-B-type natriuretic peptide (NT-proBNP) and C-reactive protein (CRP) change

Time frame:The patients will be examined after 0, 16 and 52 weeks

NT-proBNP, change

change from baseline, improvement

Other/protocol endpoint

Change in heart failure medication

Time frame:Follow-up at 52 weeks

descriptive

Patient-reported / QoL

1 endpoint

Other/protocol endpoint

EuroQol five dimensions five level (EQ-5D-5L) questionnaire

Time frame:The patients will answer a questionnaire after 0, 16 and 52 weeks

EQ-5D index

descriptive, improvement

Safety / tolerability / PK

1 endpoint

Other/protocol endpoint

Total number of Serious Adverse Events (SAEs)

Time frame:Follow-up at 52 weeks

Serious AEs (any)

event count, event

Other (unclassified)

4 endpoints

Other/protocol endpoint/low confidence

Effects of weight loss with either treatment on cardiac metabolism, fibrosis, inflammation, and diastolic function by Cardiac MRI and Cardiac Rubidium-PET

Time frame:The patients will be examined after 0, 16 and 52 weeks

descriptive

Other/protocol endpoint/low confidence

Potentially favorable changes in other organ systems caused by weight loss in this patient group

Time frame:The patients will be examined after 0, 16 and 52 weeks

descriptive

Other/protocol endpoint/low confidence

Feasibility and safety of two modern weight loss programs for aggressive weight lowering in patients with heart failure with reduced ejection fraction.

Time frame:Follow-up at 52 weeks

descriptive

Other/protocol endpoint/low confidence

Changes in systolic and diastolic function and cardiac morphology assessed by echocardiography

Time frame:The patients will be examined after 0, 16 and 52 weeks

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.