GLP‑1 plus SGLT2 therapy after a STEMI to reduce inflammation
GLP-1 and Antidiabetic SGLT2 Agents for Myocardial Infarction and Ultrasensitive Inflammatory Surveillance: An Open-Label Pilot Study
This will test whether taking semaglutide (Rybelsus) plus dapagliflozin for 24 weeks lowers blood inflammatory markers in adults who had an ST‑elevation heart attack and meet enrollment criteria.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Mexicano del Seguro Social Government |
| Locations | 1 site (León, Guanajuato) |
| Trial ID | NCT07295223 on ClinicalTrials.gov |
What this trial studies
This is a small, open‑label pilot Phase 3 trial enrolling adults with STEMI who are clinically obese, have type 2 diabetes, an initial hs‑CRP >2.0 mg/L, and LVEF >50%. Participants receive semaglutide (oral Rybelsus) and dapagliflozin 10 mg daily and are followed for 24 weeks. Inflammatory markers (hs‑CRP and IL‑6) are measured at hospital admission after PCI and again at 24 weeks to compare baseline and on‑treatment levels. Medication tolerability and adherence are monitored and patients are discharged according to standard STEMI care pathways.
Who should consider this trial
Good fit: Adults with STEMI who are clinically obese, have diagnosed type 2 diabetes, an initial hs‑CRP over 2.0 mg/L, and a left ventricular ejection fraction above 50% are the intended participants.
Not a fit: Patients without elevated baseline inflammation or those excluded for hemodynamic instability, recent immunosuppression, active infection, prior ischemic heart disease, pancreatitis, pregnancy, or recent use of the study drugs are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lower post‑MI inflammation and potentially reduce the risk of later heart failure and major cardiovascular events.
How similar studies have performed: SGLT2 inhibitors and GLP‑1 receptor agonists have shown cardiovascular benefits and some anti‑inflammatory effects in other settings, but using them together specifically to lower IL‑6/hs‑CRP after an acute STEMI is relatively novel and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Criteria for the fourth definition of acute myocardial infarction with ST-segment elevation. * Diagnosed with type 2 diabetes. * Initial serum high-sensitivity CRP value \> 2.0 mg/L. * Clinically obese. * LVEF \>50%. Exclusion Criteria: * Patients who have recently received immunosuppressive therapy * Patients with a history of ischemic heart disease * Known allergy to any of the medications used * Use of any of the study drugs more than 6 months prior to randomization * Patients experiencing diabetic ketoacidosis * Patients with hemodynamic instability (mean arterial pressure \<60 mmHg while on vasopressors) * Pregnant women * Patients with a history or current diagnosis of cancer * Patients with documented active infections, such as pneumonia or urinary tract infections * Patients with pancreatitis
Where this trial is running
León, Guanajuato
- Hospital de Especialidades No.1, Centro Médico Nacional del Bajío — León, Guanajuato, Mexico (Recruiting)
Study contacts
- Principal investigator: Rodolfo Guardado-Mendoza, Ph.D. — Universidad de Guanajuato
- Study coordinator: Hilda Elizabeth Macías-Cervantes, Ph.D.
- Email: hildamacer@gmail.com
- Phone: +52 477 7171 4800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.