Heart FailurePhase 1/2SEMAHEARTNCT06541509
Mechanisms of Semaglutide Therapy in Heart Failure Patients
A Phase 1/2 study testing Semaglutide in people with Heart Failure and Obesity, run by University Medical Centre Ljubljana at 3 sites in 2 countries.
Trial summary
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, primarily used for treatment of type-2 diabetes mellitus. GLP-1 receptors are present on pancreatic islet β-cells, δ-cells and α-cells. Their stimulation increases insulin and somatostatin secretion, and decreases glucagon secretion. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Heart Failure, Obesity
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Jul 2024to 1 Sep 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 20-80 years
- Presence of heart failure
- Body-mass index 27 kg/m2 or greater
- Stable optimally tolerated dosages of heart failure therapies for 3 months
- N-terminal pro B-type natriuretic peptide levels >350 pg/mL
Who cannot join
- Presence of type 1 or type 2 diabetes or glycated haemoglobin higher than 6.5%
- Pregnancy or potential to become pregnant
- Cancer
- Liver dysfunction (aspartate aminotransferase and/or alanine aminotransferase > 3 times upper limits of normal or total bilirubin greater than 1.5 times upper limits of normal)
- Renal dysfunction (estimated glomerular filtration rate less than 25 mL/min/1.73 m2)
- Hospitalization in the past 3 months for reasons other than heart failure
Show all 10Show fewer
- New York Heart Association (NYHA) functional class I or functional class IV symptoms.
- Prior or planned bariatric surgery
- Self-reported change in body weight >11 lbs (5 kg) within 3 months before enrollment
- Acute or chronic infection
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Greenstone Biosciences
Palo Alto, California, 94304
Mukhtar Ahmed, PhD, mukhtarahmed@greenstonebio.com
- Recruiting
Stanford Cardiovascular Institute
Stanford, California, 94305
Joseph C Wu, MD, PhD, 650-736-2246, joewu@stanford.edu
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Center Ljubljana
Ljubljana, 1000
Bojan Vrtovec, MD, PhD, +3861 522 1157, bojan.vrtovec@kclj.si
Sabina Frljak, MD, PhD, +3861 522 2844, sabina.frljak@kclj.si
About this study
Official title: A Pilot Clinical Trial Investigating Underlying Mechanisms of Semaglutide Therapy in Heart Failure Patients
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, primarily used for treatment of type-2 diabetes mellitus. GLP-1 receptors are present on pancreatic islet β-cells, δ-cells and α-cells. Their stimulation increases insulin and somatostatin secretion, and decreases glucagon secretion. In addition, GLP-1 receptor agonists appear to have multiple extrapancreatic actions, which remain poorly defined. In large clinical trials, semaglutide improved the outcomes in obese patients, patients with heart failure with preserved ejection fraction, and decreased the heart failure hospitalizations in patients with type 2 diabetes. The aim of the present study is to investigate the underlying mechanisms of the beneficial clinical effects of semaglutide in the setting of chronic heart failure.
- Conditions
- Heart Failure, Obesity
- Being tested
- Semaglutide
- Medical subject headings
- Heart Failure, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
10 overweight patients with heart failure will be enrolled, including 5 patients with heart failure with preserved ejection fraction (HFpEF) and 5 patients with heart failure with reduced ejection fraction (HFrEF). The diagnosis of HFpEF and HFrEF will be based on the most recent European Society of Cardiology guidelines for the diagnosis and treatment of heart failure.
After their baseline blood sample collections, all participants will receive once-weekly subcutaneous semaglutide (Ozempyc, Novo Nordisk A/S Bagsvaerd, Denmark) at a dose of 0.25 mg for 2 weeks, 0.5 mg for 2 weeks, and then 1.0 mg for a period of 12 weeks. At the end of the 3-month and 4-month period, blood sample collections will be repeated. All blood samples will be sent to Stanford Cardiovascular Institute for further analyses. At baseline, and again at 4 months transthoracic echocardiography, 6-minute walk test, and body composition assessment will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide Therapy | Experimental | Timepoints:
* Baseline (Week 0)
* Week 2 (Visit 1)
* Week 4 (Visit 2)
* Week 12 (Visit 3)
* Week 16 (Visit 4)
Medication Schedule:
Subcutaneous semaglutide (Ozempyc, Novo Nordisk A/S Bagsvaerd, Denmark) First 2 weeks: Semaglutide; 0.25 mg weekly Second 2 weeks: Semaglutide; 0.5 mg weekly Remaining 12 weeks: Semaglutide; 1 mg weekly Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6 (IL-6)
Measured using enzyme linked immunosorbent assay (ELISA). Units of Measure: picograms per milliliter (pg/mL).
Measured: 4 months
Interleukin-8 (IL-8)
Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
Measured: 4 months
Tumor Necrosis Factor-alpha (TNF-α)
Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
Measured: 4 months
Interferon-gamma (IFN-γ)
Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
Measured: 4 months
B-type Natriuretic Peptide (BNP)
Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).
Measured: 4 months
C-reactive Protein (CRP)
Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).
Measured: 4 months
Hemoglobin A1C (HgA1C)
Measured using standard laboratory methods. Units of Measure: percent (%).
Measured: 4 months
Complete Blood Count (CBC)
Measured using automated hematology analyzer. CBC parameters will be measured in their respective units (e.g., cells per microliter).
Measured: 4 months
Comprehensive Metabolic Panel (Chem 7)
Measured using standard laboratory methods. Chem 7 parameters will be measured in their respective units (e.g., mg/dL, U/L).
Measured: 4 months
Liver Function Tests (LFT)
Measured using standard laboratory methods. LFT parameters will be measured in their respective units (e.g., mg/dL, U/L).
Measured: 4 months
Body mass index
Patient weight will be measured in kilograms and height will be measured in meters. Body mass index (BMI) will be calculated according to the standard formula: weight in kilograms divided by height in meters squared.
Measured: 4 months
Secondary outcomes (9)
Left ventricular end-systolic volume (LVESV)
Measured using echocardiography. Units of measure: mililiter (mL)
Measured: 4 months
Left ventricular end-diastolic volume (LVEDV)
Measured using echocardiography. Units of measure: mililiter (mL)
Measured: 4 months
Myocardial mass
Measured using echocardiography. Units of measure: gram (g)
Measured: 4 months
Left ventricular ejection fraction (LVEF)
Measured using echocardiography. Units of measure: percent (%)
Measured: 4 months
Left ventricular filling pressures (E/e')
Measured using echocardiography. Units of measure: numerical value
Measured: 4 months
Global longitudinal strain (GLS)
Measured using echocardiography. Units of measure: percent (%)
Measured: 4 months
Exercise capacity
Measured by 6-minute walk test distance Units of measure: meter (m)
Measured: 4 months
Lean body mass
Measured using dual-energy X-ray absorptiometry Units of measure: gram (g)
Measured: 4 months
Fat mass
Measured using dual-energy X-ray absorptiometry Units of measure: gram (g)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start10 Jul 2024
- Primary completion10 Jul 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Greenstone Biosciences, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541509
- Sponsor's protocol ID
- SEMAHEART
- Acronym
- SEMAHEART
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial Investigating Underlying Mechanisms of Semaglutide Therapy in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT06541509
- Acronym / sponsor ID
- SEMAHEART / SEMAHEART
- Conditions
- Heart Failure, Obesity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Stanford University, Greenstone Biosciences, Inc.
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 10 Jul 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, primarily used for treatment of type-2 diabetes mellitus. GLP-1 receptors are present on pancreatic islet β-cells, δ-cells and α-cells. Their stimulation increases insulin and somatostatin secretion, and decreases glucagon secretion. In addition, GLP-1 receptor agonists appear to have multiple extrapancreatic actions, which remain poorly defined. In large clinical trials, semaglutide improved the outcomes in obese patients, patients with heart failure with preserved ejection fraction, and decreased the heart failure hospitalizations in patients with type 2 diabetes. The aim of the present study is to investigate the underlying mechanisms of the beneficial clinical effects of semaglutide in the setting of chronic heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semaglutide Therapy | Experimental | Drug: SemaglutideTimepoints: * Baseline (Week 0) * Week 2 (Visit 1) * Week 4 (Visit 2) * Week 12 (Visit 3) * Week 16 (Visit 4) Medication Schedule: Subcutaneous semaglutide (Ozempyc, Novo Nordisk A/S Bagsvaerd, Denmark) First 2 weeks: Semaglutide; 0.25 mg weekly Second 2 weeks: Semaglutide; 0.5 mg weekly Remaining 12 weeks: Semaglutide; 1 mg weekly |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 20-80 years
- Presence of heart failure
- Body-mass index 27 kg/m2 or greater
- Stable optimally tolerated dosages of heart failure therapies for 3 months
- N-terminal pro B-type natriuretic peptide levels >350 pg/mL
Key exclusion criteria (10 listed)
- Presence of type 1 or type 2 diabetes or glycated haemoglobin higher than 6.5%
- Pregnancy or potential to become pregnant
- Cancer
- Liver dysfunction (aspartate aminotransferase and/or alanine aminotransferase > 3 times upper limits of normal or total bilirubin greater than 1.5 times upper limits of normal)
- Renal dysfunction (estimated glomerular filtration rate less than 25 mL/min/1.73 m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide10 overweight patients with heart failure will be enrolled, including 5 patients with heart failure with preserved ejection fraction (HFpEF) and 5 patients with heart failure with reduced ejection fraction (HFrEF). The diagnosis of HFpEF and HFrEF will be based on the most recent European Society of Cardiology guidelines for the diagnosis and treatment of heart failure. After their baseline blood sample collections, all participants will receive once-weekly subcutaneous semaglutide (Ozempyc, Novo Nordisk A/S Bagsvaerd, Denmark) at a dose of 0.25 mg for 2 weeks, 0.5 mg for 2 weeks, and then 1.0 mg for a period of 12 weeks. At the end of the 3-month and 4-month period, blood sample collections will be repeated. All blood samples will be sent to Stanford Cardiovascular Institute for further analyses. At baseline, and again at 4 months transthoracic echocardiography, 6-minute walk test, and body composition assessment will be performed. | Drug | Semaglutide Therapy |
Primary outcome
Interleukin-6 (IL-6)
Time frame: 4 months
Measured using enzyme linked immunosorbent assay (ELISA). Units of Measure: picograms per milliliter (pg/mL).
Interleukin-8 (IL-8)
Time frame: 4 months
Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
Tumor Necrosis Factor-alpha (TNF-α)
Time frame: 4 months
Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
Interferon-gamma (IFN-γ)
Time frame: 4 months
Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
B-type Natriuretic Peptide (BNP)
Time frame: 4 months
Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).
C-reactive Protein (CRP)
Time frame: 4 months
Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).
Hemoglobin A1C (HgA1C)
Time frame: 4 months
Measured using standard laboratory methods. Units of Measure: percent (%).
Complete Blood Count (CBC)
Time frame: 4 months
Measured using automated hematology analyzer. CBC parameters will be measured in their respective units (e.g., cells per microliter).
Comprehensive Metabolic Panel (Chem 7)
Time frame: 4 months
Measured using standard laboratory methods. Chem 7 parameters will be measured in their respective units (e.g., mg/dL, U/L).
Liver Function Tests (LFT)
Time frame: 4 months
Measured using standard laboratory methods. LFT parameters will be measured in their respective units (e.g., mg/dL, U/L).
Body mass index
Time frame: 4 months
Patient weight will be measured in kilograms and height will be measured in meters. Body mass index (BMI) will be calculated according to the standard formula: weight in kilograms divided by height in meters squared.
9 secondary outcomes
Left ventricular end-systolic volume (LVESV)
Time frame: 4 months
Left ventricular end-diastolic volume (LVEDV)
Time frame: 4 months
Myocardial mass
Time frame: 4 months
Left ventricular ejection fraction (LVEF)
Time frame: 4 months
Left ventricular filling pressures (E/e')
Time frame: 4 months
Global longitudinal strain (GLS)
Time frame: 4 months
Exercise capacity
Time frame: 4 months
Lean body mass
Time frame: 4 months
Fat mass
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Semaglutide in people with Heart Failure and Obesity, run by University Medical Centre Ljubljana at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bojan Vrtovec, MD, PhD (+3861 522 1157, bojan.vrtovec@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-6 (IL-6) (time frame: 4 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.