The Role of Glucagon-Like Peptide-1 Receptor Agonists in Coronary Artery Diseases and Their Potential Mechanisms

NCT ID: NCT07073053

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-07-31

Brief Summary

The investigators plan to enroll 60 patients from the outpatient clinics or inpatient wards of the Metabolism and Cardiology departments who, within the past three months, have undergone coronary angiography for the treatment of coronary artery disease, are currently using sodium-glucose cotransporter-2 (SGLT-2) inhibitors for glycemic control, and have not received glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy for more than three months. A randomized controlled clinical trial will be conducted, with 20 participants randomly assigned to receive semaglutide (a GLP-1 RA) at 1 mg once weekly for 6 months, another 20 participants to receive semaglutide at 0.5 mg once weekly for 6 months, and the control group (20 participants) to continue with standard treatment for 6 months. The effects after 6 months will be evaluated in terms of endothelial function, glycemic control indicators including glycemic variability assessed via continuous glucose monitoring (CGM), oxidative stress markers, and the incidence of symptomatic hypoglycemia.

According to the treatment guidelines for type 2 diabetes, either GLP-1 receptor agonists or SGLT-2 inhibitors should be prioritized in patients with type 2 diabetes and coronary artery disease. Therefore, the medication choices in both the intervention and control groups in this study align with current treatment guidelines.

Conditions

Glucagon-Like Peptide-1 Receptor Agonists; Type 2 Diabetes; Coronary Arterial Disease (CAD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

semaglutide 1.0mg weekly

continue previous standard treatment with add-on semaglutide

Group Type: EXPERIMENTAL

Semaglutide 1.0 mg

Intervention Type: DRUG

add-on current standard treatment which includes SGLT2 inhibitor

semaglutide 0.5mg weekly

continue previous standard treatment with add-on semaglutide

Group Type: ACTIVE_COMPARATOR

Semaglutide 0.5 mg

Intervention Type: DRUG

add-on current standard treatment which includes SGLT2 inhibitor

control

continue previous standard treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Semaglutide 1.0 mg

add-on current standard treatment which includes SGLT2 inhibitor

Intervention Type: DRUG

Semaglutide 0.5 mg

add-on current standard treatment which includes SGLT2 inhibitor

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. adults (>=20 years old),

2. Type 2 Diabetes with coronary arterial disease underwent angioplasty within 3 months with SGLT2 inhibitors -

Exclusion Criteria

1. age<20 years old,

2. pregnant women,

3. eGFR<30 ml/min/1.73m2,

4. received GLP-1 agonist in the recent 3 months -

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Chin-Sung Kuo, M.D., Ph.D.

Role: CONTACT

cskuo@vghtpe.gov.tw

+886-2-28757513

Facility Contacts

Chin-Sung Kuo, M.D., Ph.D.

Role: primary

cskuo@vghtpe.gov.tw

+886-2-28757513

Other Identifiers

2025-02-004C

Identifier Type: -

Identifier Source: org_study_id