Mechanisms of Semaglutide Therapy in Heart Failure Patients

Part of paid clinical trials in Palo Alto, California.

Sponsor
University Medical Centre Ljubljana
Study ID
NCT06541509
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    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 Details

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.

Key Dates

Start date
Jul 10, 2024
Status verified
Jul 2024
Primary completion
Jul 10, 2025
Completion
Sep 1, 2025

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

Interleukin-6 (IL-6) [ Time Frame: 4 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Greenstone BiosciencesPalo AltoCalifornia94304
Mukhtar Ahmed, PhD
[email protected]
Stanford Cardiovascular InstituteStanfordCalifornia94305
Joseph C Wu, MD, PhD
[email protected]
650-736-2246

Find similar trials in Palo Alto, CA

By condition
Heart failureObesity / overweight
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
Greenstone Biosciences· Palo Alto, CAStanford Cardiovascular Institute· Stanford, CA

Related Studies