Phase 4 Type 2 Diabetes Trial, Recruiting NCT07314684 Sponsor: Federico II University Condition: Type 2 Diabetes
Back to Type 2 Diabetes

Phase 4 Type 2 Diabetes Trial, Recruiting

NCT07314684
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 to 85 years old
  • People who have been diagnosed with type 2 diabetes, do not have established cardiovascular disease or severe organ damage, but have a calculated cardiovascular risk score (called SCORE2-Diabetes) of 10% or higher, where a doctor has determined that starting semaglutide treatment is appropriate based on current medical guidelines
  • People who have had a CT scan of the heart's arteries (within the last 2 years) showing no blockages of 50% or more in the main heart arteries, as confirmed by a specialist laboratory
  • People whose blood pressure, cholesterol, and blood sugar levels have been stable and well-controlled, based on tests done within the 4 weeks before joining
  • People who have been on a stable diabetes medication routine for at least 6 weeks
  • People whose heart is pumping at a normal or near-normal level (a heart pump function of 50% or more)
  • Female participants must not be pregnant or breastfeeding, and must be confirmed as unable to become pregnant — either through being post-menopausal (no periods for 12 or more months after stopping any hormone treatments, confirmed by specific hormone blood tests) or through having had an irreversible surgical procedure such as removal of the uterus, both ovaries, or both fallopian tubes (note: tubal ligation does not meet this requirement)
  • People who are able to understand the study procedures and provide signed informed consent

Who may not be able to join:

  • People older than 85 years
  • People who have previously been treated with semaglutide or similar medications in the same drug class (called GLP-1 receptor agonists)
  • People who have a blockage of 50% or more in the main arteries of the heart
  • People with significantly reduced kidney function, or kidney function in a certain lower range combined with signs of kidney damage such as protein in the urine, or evidence of small blood vessel disease affecting three or more parts of the body (confirm with trial site)
  • People with any significant existing medical condition that, in the doctor's opinion, could put them at risk or affect the trial results
  • People with any history of cardiovascular disease (such as heart attack or stroke)
  • People with the most severe class of heart failure (New York Heart Association Class IV)
  • People with significant heart valve problems
  • People with type 1 diabetes
  • People with a known allergy or sensitivity to semaglutide or any of its ingredients
  • People with known or suspected liver disease, shown by liver enzyme levels more than three times the normal range
  • People who have had an acute inflammatory or infectious illness in the 3 months before joining
  • People with ongoing chronic inflammatory, immune system, or infectious conditions
  • People with a history of cancer within the past 5 years
  • People with a history of alcohol, drug, or medication misuse
  • People who have been exposed to radiation (medical or occupational) (confirm with trial site)
  • People with significant blood disorders
  • People with poorly controlled or unstable metabolic conditions
  • People who have misused alcohol or drugs in the previous 3 months

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Federico II University
Registry
ClinicalTrials.gov
Start date
8 September 2025
Est. completion
8 March 2027

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

To evaluate the effects of semaglutide in addition to standard therapy on inflammatory biomarkers compared with standard therapy alone in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10%.; To evaluate the effects of semaglutide in addition to standard therapy on biomarkers of endothelial dysfunction compared with standard therapy alone in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10%.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov