Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Diabetes drug semaglutide may fight inflammation and protect blood vessels

NCT ID NCT07314684

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 4 trial tests whether adding semaglutide to standard diabetes treatment reduces inflammation and improves blood vessel health in 80 people with type 2 diabetes who have no heart disease. Participants receive either semaglutide injections plus standard care or standard care alone for 52 weeks. Researchers will measure changes in inflammatory markers and blood vessel function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
semaglutide (a GLP-1 receptor agonist drug)
What this could lead to
If successful, this could show that semaglutide helps control inflammation and blood vessel damage in type 2 diabetes, potentially reducing heart disease risk.
What could go wrong
This is a small, early-phase trial (80 people) looking at biomarkers, not clinical outcomes. The results may not translate to fewer heart attacks or strokes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years. * Diagnosis of T2DM in patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10% with clinical indication in accordance with current guidelines \[1\] to initiate semaglutide therapy (level of evidence IIa). * Evaluable, pre-randomization CTA with no evidence of stenosis ≥50% of epicardial coronary vessels, as confirmed by the core laboratory, performed within 2 years prior to inclusion. * Stable clinical conditions, with controlled blood pressure, lipid profile, and glycemic values, based on assessments performed within 4 weeks prior to inclusion. * Stable antidiabetic treatment for at least 6 weeks. * Left ventricular ejection fraction ≥50%. * For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at enrollment by one of the following: (a) Postmenopausal, defined as amenorrhea for ≥12 months following cessation of fall exogenous hormonal treatments, and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range. (b) Documentation of irreversible surgical sterilization by hysterectomy bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization. * Ability to understand study procedures and sign informed consent. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Age \> 85 years. * Previous treatment with semaglutide or GLP1-RAs. * Patients with stenosis of epicardial coronary arteries ≥50%. * eGFR \<45 mL/min/1.73 m2 irrespective of albuminuria or eGFR 45-59 mL/min/1.73 m2 and microalbuminuria (UACR 30-300 mg/g; stage A2) or proteinuria (UACR \>300 mg/g; stage A3) or presence of microvascular disease in at least three different sites \[e.g. microalbuminuria (stage A2) plus retinopathy plus neuropathy\], based on assessments performed within 4 weeks prior to inclusion. * History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study. * Any history of ASCVD. * Ongoing New York Heart Association Class IV (heart failure (HF). * Significant valvulopathy. * Type 1 diabetes mellitus. * Hypersensitivity to the active substance or to any of the excipients. * Known or suspected liver disease, defined by serum transaminase and alkaline phosphatase levels 3 times the normal level. * Patients with acute inflammatory or infectious diseases during the 3 months prior to inclusion in the study. * Patients with chronic inflammatory, immune or infectious diseases. * Patients with a history of cancer within the past 5 years. * History of alcohol, drug or medication abuse. * Patients exposed to any other type of radiation, medical or professional. * Clinically relevant haematological disorders. * Decompensated metabolic disorders. * Abuse of alcohol or drugs in the previous 3 months.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for T2DM (type 2 diabetes mellitus) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliera Sant'Anna e San Sebastiano

    RECRUITING

    Caserta, Caserta, 81100, Italy

  • Federico II University

    RECRUITING

    Naples, Napoli, 80131, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.