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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country	Status
Azienda Ospedaliera Sant Anna E San Sebastiano Di Caserta	Caserta	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.09.2025

Trial locations

Investigated drugs:

Semaglutide

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.

Investigated diseases:

Type 2 diabetes mellitus

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 ID:

2025-520802-37-00

Protocol code:

STABLE-GLP1

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?