ARMYDA - 10 study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-01-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

University of Eastern Piedmont

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

This study aims to evaluate anti-inflammatory actions of oral semaglutide within coronary plaques by measuring changes in the macrophage arc.

Secondary objectives 1

1. Secondary objectives include the effects of semaglutide on: improvement of coronary plaque stabilization features, in particular lipid arc decrease, fibrous cap thickening and plaque volume reduction; amelioration of endothelial function, lipid metabolism and inflammatory markers.

Conditions and MedDRA coding

non-ST-elevation myocardial infarction (NSTEMI); unstable angina

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. - Diagnosis of T2DM - Non-ST-segment elevation ACS - Presence of one identifiable culprit coronary lesion treated with percutaneous coronary intervention (PCI) - Presence of at least one non-culprit, mild to intermediate stenosis (30% to 69% lumen narrowing) at coronary angiography, with a macrophage arc detectable on optical coherence tomography (OCT), on a major epicardial coronary artery different from the culprit vessel - Age ≥40 years - Signed informed consent.

Exclusion criteria 1

1. - Acute heart failure - Renal dysfunction (estimated GFR <30 mL/min/1.73 m²) or dialysis - History or high risk of pancreatitis. - Severe gastroparesis requiring therapy <6 months prior to randomization. - Active malignancy or history of neuroendocrine tumors. - Hypersensitivity or contraindications to semaglutide or its excipients. - Severe hepatic dysfunction (ALT/AST >2× upper limit of normal or total bilirubin >1.5× upper limit of normal). - Pregnancy or breastfeeding. Women of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study. - Patients with diabetic ketoacidosis - Use of semaglutide at screening within 30 days prior to randomization. - Inability to provide informed consent.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. the change of the maximum macrophage arc (degrees) in non-culprit coronary stenoses from baseline to 24 weeks, measured by OCT, in the semaglutide vs control arm

Secondary endpoints 1

1. changes from baseline to 24 weeks in OCT parameters (lumen area, plaque volume, fibrous cap thickness, lipid/calcium arcs and lengths), plaque composition (fibrous, fibro-calcific, fibro-atheroma, TCFA), prevalence of healed and macrophage-rich plaques, HbA1c, BMI, and incidence of cardiovascular events and adverse effects.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Sponsor organisation

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Address

Corso Giuseppe Mazzini 18

City

Novara

Postcode

28100

Country

Italy

Scientific contact point

Organisation

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Contact name

Giuseppe Patti

Public contact point

Organisation

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Contact name

Giuseppe Patti

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications