NCT06541509

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1 heart-failure

Timeline
Completed

Started Jul 2024

Geographic Reach
2 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 11, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 7, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 11, 2024

Last Update Submit

August 5, 2024

Conditions

Heart FailureObesity

Outcome Measures

Primary Outcomes (11)

  • Interleukin-6 (IL-6)

    Measured using enzyme linked immunosorbent assay (ELISA). Units of Measure: picograms per milliliter (pg/mL).

    4 months

  • Interleukin-8 (IL-8)

    Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).

    4 months

  • Tumor Necrosis Factor-alpha (TNF-α)

    Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).

    4 months

  • Interferon-gamma (IFN-γ)

    Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).

    4 months

  • B-type Natriuretic Peptide (BNP)

    Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).

    4 months

  • C-reactive Protein (CRP)

    Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).

    4 months

  • Hemoglobin A1C (HgA1C)

    Measured using standard laboratory methods. Units of Measure: percent (%).

    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).

    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).

    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).

    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.

    4 months

Secondary Outcomes (9)

  • Left ventricular end-systolic volume (LVESV)

    4 months

  • Left ventricular end-diastolic volume (LVEDV)

    4 months

  • Myocardial mass

    4 months

  • Left ventricular ejection fraction (LVEF)

    4 months

  • Left ventricular filling pressures (E/e')

    4 months

  • +4 more secondary outcomes

Study Arms (1)

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

Drug: Semaglutide

Interventions

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.

Semaglutide Therapy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Greenstone Biosciences

Palo Alto, California, 94304, United States

RECRUITING

Stanford Cardiovascular Institute

Stanford, California, 94305, United States

RECRUITING

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Heart FailureObesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Bojan Vrtovec, MD, PhD

CONTACT

+3861 522 1157bojan.vrtovec@kclj.si

Sabina Frljak, MD, PhD

CONTACT

+3861 522 2844sabina.frljak@kclj.si

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2024

First Posted

August 7, 2024

Study Start

July 10, 2024

Primary Completion

July 10, 2025

Study Completion

September 1, 2025

Last Updated

August 7, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)SL(1)