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Study of semaglutide effects on inflammation markers in patients with type 2 diabetes mellitus who have high cardiovascular risk

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with Type 2 diabetes mellitus, a condition where the body has trouble controlling blood sugar levels. The study will test a medication called semaglutide, which belongs to a group of drugs known as GLP-1 receptor agonists. This medicine is given as an injection under the skin using a pre-filled syringe.

The purpose of this research is to examine how semaglutide, when added to standard diabetes treatment, affects certain markers of inflammation and blood vessel health in people with Type 2 diabetes who have not yet developed heart disease but may be at risk for it. The study will compare patients receiving semaglutide plus standard treatment to those receiving standard treatment alone.

During the study, participants will receive different doses of semaglutide, starting with a lower dose that will be gradually increased over time. The treatment will continue for approximately one year, during which various health measurements will be taken to monitor the effects of the medication. The maximum daily dose of semaglutide that participants may receive is 1 milligram.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    A medical evaluation will confirm your eligibility for the study based on specific criteria, including having type 2 diabetes and meeting certain health parameters

    Your blood pressure, lipid profile, and blood sugar levels will be checked to ensure they are stable

    Your heart function will be verified to confirm a left ventricular ejection fraction of 50% or higher

  2. Step 2

    Treatment assignment

    You will be assigned to receive either semaglutide injections with standard therapy or standard therapy alone

    If assigned to the semaglutide group, you will receive the medication as a pre-filled injection solution

  3. Step 3

    Treatment period

    The study will continue for 52 weeks (one year)

    Regular monitoring of your health status will occur throughout this period

    Blood samples will be collected to measure inflammatory markers and other biological indicators

  4. Step 4

    Safety monitoring

    Your health status will be monitored for any side effects or medical concerns throughout the study period

    Any changes in your condition or unexpected events will be recorded and evaluated

  5. Step 5

    Final evaluation

    At the end of the 52-week period, final blood tests will be conducted

    A complete assessment of your health status will be performed

    The study team will evaluate all collected data to assess the effectiveness of the treatment

Who can join the trial?

12 criteria

  • Must be at least 18 years old
  • Must have been diagnosed with Type 2 diabetes without severe organ damage or heart disease, but with a high risk score (SCORE2-Diabetes of 10% or higher)
  • Must have had a coronary CT scan (a special X-ray of heart arteries) within the last 2 years showing no significant narrowing of heart vessels
  • Must have stable health conditions, including:
    • Controlled blood pressure
    • Controlled cholesterol levels
    • Controlled blood sugar levels
    • Must have been on stable diabetes medication for at least 6 weeks
    • Must have normal heart pumping function (ejection fraction of 50% or higher)
    • For women participants:
      • Must not be pregnant or breastfeeding
      • Must either be past menopause (no periods for 12 months or more)
      • Or have had surgery that prevents pregnancy (such as removal of uterus or ovaries)
      • Must be able to understand the study procedures and provide informed consent

Who cannot join the trial?

15 criteria

  • History of cardiovascular disease (diseases affecting heart and blood vessels)
  • Current treatment with GLP-1 receptor agonists (medications used for diabetes control)
  • Known allergies to the study medication or its components
  • Severe kidney disease (poor kidney function)
  • History of pancreatitis (inflammation of the pancreas)
  • Current or history of medullary thyroid cancer
  • Multiple endocrine neoplasia syndrome type 2 (inherited condition affecting hormone-producing glands)
  • Pregnancy or planning to become pregnant
  • Currently breastfeeding
  • Participation in another clinical trial within the past 30 days
  • Hemoglobin A1c (blood sugar control measure) above 10%
  • Unstable body weight or significant diet changes in the past 3 months
  • History of gastroparesis (delayed stomach emptying)
  • Active liver disease or significantly elevated liver function tests
  • History of alcohol or drug abuse within the past 12 months
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Investigated drugs

  • Semaglutide

    This medication belongs to a group called GLP-1 receptor agonists (GLP1-RAs). It helps control blood sugar levels in people with type 2 diabetes. The medication works by mimicking a natural hormone in your body that helps regulate blood sugar, appetite, and may help reduce inflammation in blood vessels. It's typically given as an injection under the skin.

  • Standard therapy

    This refers to the usual medications and treatments that patients with type 2 diabetes normally receive to manage their condition. This may include medications to control blood sugar, blood pressure, and cholesterol levels, along with recommendations for diet and exercise.

What is already known about the treatment

Semaglutide - A prescription medication administered via subcutaneous injection that belongs to the class of GLP-1 receptor agonists (glucagon-like peptide-1 receptor agonists). This medication works by mimicking the natural hormone GLP-1, which helps regulate blood sugar levels by stimulating insulin production when blood glucose is high, reducing glucagon secretion, and slowing down digestion. Currently widely used in clinical practice for treating type 2 diabetes mellitus, semaglutide has shown significant effectiveness in blood glucose control and has demonstrated additional benefits in cardiovascular risk reduction and weight management. The medication is typically administered once weekly, making it a convenient option for long-term diabetes management compared to daily treatments.

Investigated diseases

Type 2 diabetes mellitus - A chronic metabolic disorder characterized by high blood sugar levels due to the body's ineffective use of insulin or reduced insulin production. The condition typically develops gradually, with the pancreas initially producing extra insulin to compensate for insulin resistance. Over time, the body becomes less able to use insulin effectively, leading to elevated blood glucose levels. Common signs include increased thirst, frequent urination, fatigue, and slow-healing wounds. The condition often develops in adults and is associated with lifestyle factors such as obesity and physical inactivity. The disease can progress over time, affecting how the body processes glucose for energy.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520802-37-00Protocol codeSTABLE-GLP1Estimated enrolment80 patientsSponsorUniversita' Degli Studi Di Napoli Federico II

sourced from the EU Clinical Trials Register and site verification

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