Recruiting
Phase 1
Phase 2

Semaglutide

Sponsor:

University Medical Centre Ljubljana

Code:

NCT06541509

Conditions

Heart Failure

Obesity

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Semaglutide

Study Details

Brief 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. 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

Study ID

NCT06541509

Start date

Jul 10, 2024

Status verified date

Jul, 2024

Completion date

Sep 1, 2025

Anticipated

Primary completion date

Jul 10, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Semaglutide Therapy

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

Interventions

Semaglutide

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.

Primary outcome measure

  • Interleukin-6 (IL-6) [ Time Frame: 4 months ]
  • Interleukin-8 (IL-8) [ Time Frame: 4 months ]
  • Tumor Necrosis Factor-alpha (TNF-α) [ Time Frame: 4 months ]
  • Interferon-gamma (IFN-γ) [ Time Frame: 4 months ]
  • B-type Natriuretic Peptide (BNP) [ Time Frame: 4 months ]
  • C-reactive Protein (CRP) [ Time Frame: 4 months ]
  • Hemoglobin A1C (HgA1C) [ Time Frame: 4 months ]
  • Complete Blood Count (CBC) [ Time Frame: 4 months ]
  • Comprehensive Metabolic Panel (Chem 7) [ Time Frame: 4 months ]
  • Liver Function Tests (LFT) [ Time Frame: 4 months ]
  • Body mass index [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Bojan Vrtovec, MD, PhD

+3861 522 1157bojan.vrtovec@kclj.si

Sabina Frljak, MD, PhD

+3861 522 2844sabina.frljak@kclj.si

Locations

Greenstone Biosciences

Recruiting

Palo Alto, California, United States, 94304

Contacts

Mukhtar Ahmed, PhD

mukhtarahmed@greenstonebio.com

Stanford Cardiovascular Institute

Recruiting

Stanford, California, United States, 94305

Contacts

Joseph C Wu, MD, PhD

650-736-2246joewu@stanford.edu

More Information

Sponsor

University Medical Centre Ljubljana

Last update posted

Aug 7, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Medical Centre Ljubljana on 2024-08-07.