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Myocardial InjuryPhase 4GLUMINSNCT06324461

GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery

A Phase 4 study testing Dulaglutide 0.75mg subcutaneous injection in people with Myocardial Injury, run by The University of Hong Kong at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is an investigator initiated, multi-center, open-labelled, superiority randomized controlled trial of 372 patients undergoing elective non-cardiac surgery. Recruited patients will be randomized in a 2:1 ratio to receive single subcutaneous dose of Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RAs) 1 to 14 days… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Injury
What is being tested?
Dulaglutide 0.75mg subcutaneous injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
372 participants
Where
3 sitesChina
Study dates
20 Mar 2024to 31 Dec 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Planned elective intermediate to high risk non-cardiac surgery
  • Anticipated to remain hospitalized for at least one night after surgery
  • Voluntarily agrees to participate by providing written informed consent

Who cannot join

  • History of symptomatic hypoglycemia within 1 month of recruitment
  • History of pancreatitis
  • Diabetic retinopathy
  • Personal or family history of medullary thyroid carcinoma (MTC)
  • Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • Acute coronary syndrome, decompensated heart failure, cardiogenic shock, or myocarditis within 1 month of recruitment
Show all 13Show fewer
  • Stroke or transient ischemic attack within 1 month of recruitment
  • Known severe liver disease (Child-Pugh B or C)
  • Stage 5 chronic kidney disease (estimated glomerular filtration rate (eGFR) by Modified Diet in Renal Disease (MDRD) equation < 15 mL/min)
  • Recent use of GLP-1 RA within 1 month of recruitment
  • Known allergy or hypersensitivity to GLP-1 RA
  • Women of childbearing age who are not taking effective contraception, or who are pregnant or breast-feeding
  • Use of Dipeptidyl peptidase-4 inhibitor(DPP4i)

Trial locations and contacts

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

Chun Ka Wong, Clinical Assistant Professor contact

+852 2255 3597

wongeck@hku.hk

Lily Hung, Master contact

+852 2255 4169

nga98@hku.hk

China3 sites, 3 recruiting
  • Duchess of Kent Children's Hospital at Sandy Bay

    Hong Kong, Hong Kong SAR

    Not yet recruiting
  • Queen Mary Hospital

    Hong Kong, Hong Kong SAR

    Recruiting
  • Tung Wah Hospital

    Hong Kong, Hong Kong SAR

    Recruiting

Other trials in China

About this study

Official title: Glucagon-like Peptide-1 Receptor Agonist for Reduction of Myocardial Injury After Non-Cardiac Surgery

This is an investigator initiated, multi-center, open-labelled, superiority randomized controlled trial of 372 patients undergoing elective non-cardiac surgery. Recruited patients will be randomized in a 2:1 ratio to receive single subcutaneous dose of Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RAs) 1 to 14 days prior to surgery or receive routine care.

Dulaglutide (Trulicity; Eli Lilly, USA) is chosen as GLP-1 Receptor Agonists investigational drug for this study. Apart from peri-operative routine care, all recruited subjects will undergo physical, respiratory and cardiac assessments including electrocardiography and blood check including cardiac enzymes. Myocardial injury, cardiovascular outcomes and safety will be assessed and evaluated for efficacy and safety of this prophylactic measurement for the reduction of myocardial injury after non-cardiac surgery.

Read the detailed description

Myocardial injury following non-cardiac surgery (MINS) is increasingly recognized as a major cause of peri-operative morbidity and mortality worldwide. MINS is defined as post-operative cardiomyocyte injury that can be detected by high-sensitive troponin assays, which may or may not be associated with symptoms or changes on electrocardiogram (ECG). Globally, it was found that 35.5% patients had MINS with elevated troponin level in the early post-operative period. Post-operative troponin T level strongly correlated with peri-operative mortality. It was demonstrated that elevated troponin T level to 14-20 ng/L after surgery significantly increased 30-day mortality with hazard ratio of 9.11. As the global volume of non-cardiac surgeries continues to increase, there is an urgent need to identify effective strategies to minimize MINS. To date, no pharmacological intervention has been shown to safely reduce MINS.

This study will evaluate the effect of pre-operative glucagon-like peptide 1 receptor agonists (GLP-1 RAs) on MINS. GLP-1 is a peptide hormone produced by intestinal epithelial endocrine L-cells that stimulates insulin secretion and inhibits glucagon secretion. GLP-1 RAs have been used to treat both diabetic and non-diabetic conditions. In landmark cardiovascular outcome trials, GLP-1 RAs were shown to reduce major adverse cardiovascular events (MACE) when compared with placebo. GLP-A RAs exert beneficial effects by stabilizing atherosclerotic plaques. Animal studies revealed that a GLP-1 RAs attenuate activation and recruitment of monocytes and macrophages to the arterial wall by suppressing expression of interleukin 6 (IL-6), chemokine (C-C motif) ligand 2 (CCL2), vascular cell adhesion molecule 1 (VCAM-1), and E- selectin (SELE). GLP-1 RAs also suppress vascular smooth muscle cell proliferation and migration via the Cyclic adenosine monophosphate (cAMP) or protein kinase A (PKA) pathway. Another key advantage of using GLP-1 RA in the context of surgery is intra-operative stabilization of glycemic level. It is well established that intra-operative hyperglycemia is associated with increased risk of MINS. Prospective studies have revealed that GLP-1 RA infusion during the peri-operative period resulted in better glycemic control among diabetic and non-diabetic patients without significantly increasing hypoglycemia risk.

The "Glucagon-like Peptide-1 Receptor Agonist for Reduction of Myocardial Injury after Non-Cardiac Surgery" (GLUMINS) trial is an investigator initiated, multi-center, open-labelled Randomized Controlled Trial that will determine the effect of pre-operative GLP-1 RAs on MINS. The study hypothesis is that pre-operative GLP-1 RAs will reduce myocardial injury in patients undergoing non-cardiac surgery. Critically needed new knowledge will be generated about the effectiveness of GLP-1 RAs as a peri-operative intervention to reduce MINS, which may fundamentally alter peri-operative management in non-cardiac surgeries.

Being tested
Dulaglutide 0.75mg subcutaneous injection
Keywords
Myocardial injury following non-cardiac surgery, glucagon-like peptide 1 receptor agonists, Dulaglutide

What participants receive

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

  • Dulaglutide 0.75mg subcutaneous injectionDrug

    Also called Trulicity 0.75mg subcutaneous injection

    Subject randomized into treatment group will receive single subcutaneous dose of Dulaglutide 0.75mg 1 to 14 days prior to surgery

Study groups in NCT06324461
Study groupRoleWhat they receive
Dulaglutide groupExperimentalSubject randomized into this group will receive single subcutaneous dose of Dulaglutide 0.75mg 1 to 14 days prior to surgery, on top of routine peri-operative care
Receives: Drug: Dulaglutide 0.75mg subcutaneous injection
Control groupNo interventionSubject randomized into this group will receive routine peri-operative care

What is being measured

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

  1. Proportion of patients with MINS

    Defined as any elevation in troponin T >= 14ng/L

    Measured: Within 72 hours after surgery

Secondary outcomes (11)
  1. Proportion of patients with composite of non-fatal MINS, non-fatal stroke or cardiovascular mortality

    Measured: Within 30 days of randomization

  2. Proportion of patients with MINS who do not fulfill the 4th universal definition of myocardial infarction

    Measured: Within 30 days of randomization

  3. Proportion of patients with myocardial infarction according to the 4th universal definition of myocardial infarction

    Measured: Within 30 days of randomization

  4. Proportion of patients with ischemic stroke

    Measured: Within 30 days of randomization

  5. Proportion of patients with cardiovascular death

    Measured: Within 30 days of randomization

  6. Proportion of patients with all-cause mortality

    Measured: Within 30 days of randomization

  7. Mean days alive and out of hospital

    Measured: Within 30 days of randomization

  8. Clinically important atrial fibrillation

    Measured: Within 30 days of randomization

  9. Clinically significant hypoglycaemia

    Measured: Within 30 days of randomization

  10. Mean peak troponin T concentration

    Measured: During the period of index hospitalization up to 3 days

  11. Mean area under curve of troponin T concentration

    Measured: During the period of index hospitalization up to 3 days

Timeline

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

  1. First posted22 Mar 2024
  2. Study start20 Mar 2024
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-labelled, superiority randomized controlled trial
Masking
None (open label)
Enrolment
372 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06324461
Sponsor's protocol ID
GLUMINS
Acronym
GLUMINS
Status last verified
Apr 2026
First submitted
30 Mar 2023
Last updated
4 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Writing Committee for the VSI, Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS and Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017;317:1642-1651.

  • 1. Halvorsen S, Mehilli J, Cassese S, Hall TS, Abdelhamid M, Barbato E, De Hert S, de Laval I, Geisler T, Hinterbuchner L, Ibanez B, Lenarczyk R, Mansmann UR, McGreavy P, Mueller C, Muneretto C, Niessner A, Potpara TS, Ristic A, Sade LE, Schirmer H, Schupke S, Sillesen H, Skulstad H, Torracca L, Tutarel O, Van Der Meer P, Wojakowski W, Zacharowski K, Group ESCSD, Knuuti J, Kristensen SD, Aboyans V, Ahrens I, Antoniou S, Asteggiano R, Atar D, Baumbach A, Baumgartner H, Bohm M, Borger MA, Bueno H, Celutkiene J, Chieffo A, Cikes M, Darius H, Delgado V, Devereaux PJ, Duncker D, Falk V, Fauchier L, Habib G, Hasdai D, Huber K, Iung B, Jaarsma T, Konradi A, Koskinas KC, Kotecha D, Landmesser U, Lewis BS, Linhart A, Lochen ML, Maeng M, Manzo-Silberman S, Mindham R, Neubeck L, Nielsen JC, Petersen SE, Prescott E, Rakisheva A, Saraste A, Sibbing D, Siller-Matula J, Sitges M, Stankovic I, Storey RF, Ten Berg J, Thielmann M and Touyz RM. 2022 ESC Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery. Eur Heart J. 2022.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dulaglutide 0.75mg subcutaneous injection in people with Myocardial Injury, run by The University of Hong Kong at 3 sites in China.

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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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 Chun Ka Wong, Clinical Assistant Professor (+852 2255 3597, wongeck@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with MINS (time frame: Within 72 hours after surgery). 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 NCT06324461, which also lists 2 linked publications.

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 4 May 2026.

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