Diabetes drug semaglutide may fight inflammation and protect blood vessels
NCT ID NCT07314684
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Azienda Ospedaliera Sant'Anna e San Sebastiano
RECRUITINGCaserta, Caserta, 81100, Italy
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Federico II University
RECRUITINGNaples, Napoli, 80131, Italy
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