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Glucagon-Like Peptide-1 Receptor AgonistsPhase 4NCT07073053

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

A Phase 4 study testing Semaglutide 1.0 mg and Semaglutide 0.5 mg in people with Glucagon-Like Peptide-1 Receptor Agonists and Type 2 Diabetes, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Semaglutide 1.0 mg and Semaglutide 0.5 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTaiwan
Study dates
1 Oct 2025to 31 Jul 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adults (>=20 years old),
  • Type 2 Diabetes with coronary arterial disease underwent angioplasty within 3 months with SGLT2 inhibitors -

Who cannot join

  • age<20 years old,
  • pregnant women,
  • eGFR<30 ml/min/1.73m2,
  • received GLP-1 agonist in the recent 3 months -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

+886-2-28757513

cskuo@vghtpe.gov.tw

Taiwan1 site

  • Taipei Veterans General Hospital

    Taipei, 112

    Chin-Sung Kuo, M.D., Ph.D., +886-2-28757513, cskuo@vghtpe.gov.tw

Other trials in Taiwan

About this study

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.

Being tested
Semaglutide 1.0 mg, Semaglutide 0.5 mg
Keywords
Glucagon-Like Peptide-1 Receptor Agonists, type 2 diabetes, coronary arterial disease
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide 1.0 mgDrug

    add-on current standard treatment which includes SGLT2 inhibitor

  • Semaglutide 0.5 mgDrug

    add-on current standard treatment which includes SGLT2 inhibitor

Study groups in NCT07073053
Study groupRoleWhat they receive
semaglutide 1.0mg weeklyExperimentalcontinue previous standard treatment with add-on semaglutide
Receives: Drug: Semaglutide 1.0 mg
semaglutide 0.5mg weeklyActive comparatorcontinue previous standard treatment with add-on semaglutide
Receives: Drug: Semaglutide 0.5 mg
controlNo interventioncontinue previous standard treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change of Time-in-range (%)

    continuous glucose monitor, time-in-range defined as percentage of time in range of 70-180 blood glucose levels. Change of time-in-range means time-in-range at week 24 - time-in-range at baseline.

    Measured: From enrollment to the end of treatment at 24 weeks

  2. change of HbA1c

    HbA1c at week 24 - HbA1c at baseline

    Measured: From enrollment to the end of treatment at 24 weeks

  3. change of Flow-Mediated Dilatation (FMD)

    Flow-Mediated Dilatation (FMD) at week 24 - Flow-Mediated Dilatation (FMD) at baseline

    Measured: From enrollment to the end of treatment at 24 weeks

Secondary outcomes (4)

  1. change of serum ROS measurements

    serum ROS measurements at week 24 - serum ROS measurements at baseline

    Measured: From enrollment to the end of treatment at 24 weeks

  2. change of Peripheral Arterial Tonometry (PAT)

    Peripheral Arterial Tonometry (PAT) at week 24 - Peripheral Arterial Tonometry (PAT) at baseline

    Measured: From enrollment to the end of treatment at 24 weeks

  3. Hypoglycemic episodes

    the amount of hypoglycemic episodes during the treatment period of 24 weeks. hypoglycemic episodes defined as blood sugar levels less than 50 or with hypoglycemic symptoms.

    Measured: from enrollment to the end of treatment at week 24.

  4. change of fasting glucose

    fasting glucose ar week 24 - fasting glucose at baseline

    Measured: From enrollment to the end of treatment at week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07073053
Sponsor's protocol ID
2025-02-004C
Status last verified
Jul 2025
First submitted
16 Jun 2025
Last updated
18 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The IPD share plan was not mentioned in this patient consent form.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Semaglutide 1.0 mg and Semaglutide 0.5 mg in people with Glucagon-Like Peptide-1 Receptor Agonists and Type 2 Diabetes, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chin-Sung Kuo, M.D., Ph.D. (+886-2-28757513, cskuo@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change of Time-in-range (%) (time frame: From enrollment to the end of treatment at 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07073053.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.

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