Effect of Glp-1 and Antidiabetic sgLT2 Agents for myoCardial infarcTion and Ultrasensitive Inflammatory Surveillance (GALACTUS Trial)

NCT07295223 | Recruiting Phase 3 DMC

• 1 other identifier: F-2024-1001-136
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The primary risk factor for coronary artery disease is atherosclerosis, with inflammation playing a crucial role in the development and progression of this condition. It has now been proven that inflammation is key in the development of complications after an acute myocardial infarction. These complications can be immediate and mechanical, such as ventricular wall rupture and ventricular arrhythmia, or long-term, presenting as major cardiovascular events like heart failure. During acute myocardial infarction (AMI), circulating high-sensitivity CRP levels increase approximately 6 hours after the onset of ischemia. CRP levels measured between 24 and 72 hours after symptom onset are a significant prognostic marker for one-year outcomes. Higher high-sensitivity CRP levels at the time of AMI are linked to more severe coronary atherosclerotic lesions seen on angiography and lower LVEF one month after the event. A serum high-sensitivity CRP concentration greater than 10 mg/L after an AMI indicates inflammation, reflecting myocardial necrosis, plaque rupture, and acute thrombosis. In patients with AMI, persistent or increasing CRP levels are strongly associated with a higher risk of all-cause and non-cardiovascular death, especially when inflammation (CRP \> 2.0 mg/L) continues for a year. Aside from reperfusion therapy, very few pharmacological approaches have been used to reduce inflammation after AMI. One such approach was the use of colchicine in the COVERT-MI randomized, double-blind, multicenter trial. This trial compared five days of oral colchicine with a placebo and found no difference in infarct size between the groups at five days or three months, as measured by cardiac magnetic resonance imaging. SGLT-2 inhibitors are drugs that have revolutionized the management of cardiovascular diseases, offering proven benefits for patients with heart failure and notable nephroprotective effects. However, their use after acute myocardial infarction has not yet been sufficiently established, as the only two published clinical trials so far failed to meet their primary goal of reducing hospitalizations for heart failure. Additionally, evidence of their use in post-AMI inflammation exists only in experimental studies. In experimental studies, SGLT2 global-knockout (KO) mice were used to demonstrate that dapagliflozin significantly influences cardiac fibrosis and inflammation, and markedly alters the gene expression profiles of macrophages and fibroblasts. Moreover, dapagliflozin directly inhibited macrophage-mediated inflammation, thereby suppressing cardiac fibroblast activation. Similarly, only experimental studies have shown that semaglutide decreases elevated levels of TNF-α, IL-6, ROS, and MDA in the serum and cardiac tissues of obese mice. By lowering the expression of Cxcl2, S100a8, and S100a9 in neutrophils, semaglutide may help reduce cardiac inflammation and oxidative stress. Therefore, the objective of this study is to compare the effects of dapagliflozin and semaglutide on inflammatory markers (hs-CRP and IL-6) in patients with acute ST-segment elevation myocardial infarction.

Conditions

Acute Myocardial Infarction With ST Elevation

Keywords

STEMI; Semaglutide; Dapagliflozin; High-sensitivity PCR

Outcome Measures

Primary Outcomes (2)

• Inflammatory markers (high-sensitivity PCR)

  Patients with hsCRP \> 2 mg/L will be included, and a control will be taken to assess the change after 24 weeks of treatment.

  24 weeks.

• Inflammatory markers (interleukin 6)

  Patients with IL-6 \> 2 ng/L will be included, and a control will be taken to assess the change after 24 weeks of treatment.

  24 weeks

Secondary Outcomes (3)

• Epicardial fat

  24 weeks

• LDL cholesterol

  24 weeks

• Change in glucose and HbA1c

  24 weeks

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10 mg daily for 24 weeks

Drug: Dapagliflozin 10 MG Oral Tablet

Semaglutide

ACTIVE COMPARATOR

Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours over 24 weeks.

Drug: Semaglutide (Rybelsus®)

Interventions

Dapagliflozin 10 MG Oral Tablet DRUG

10 mg dapagliflozin daily for 24 weeks

Dapagliflozin

Semaglutide (Rybelsus®) DRUG

Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours over 24 weeks.

Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead
• Universidad de Guanajuato: collaborator

Study Sites (1)

Hospital de Especialidades No.1, Centro Médico Nacional del Bajío

León, Guanajuato, 37320, Mexico

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

dapagliflozin; semaglutide

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Rodolfo Guardado-Mendoza, Ph.D.

  Universidad de Guanajuato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilda Elizabeth Macías-Cervantes, Ph.D.

CONTACT

+52 477 7171 4800; hildamacer@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)