RecruitingPhase 2ACTRN12625001164482

Randomised controlled trial on GLP-1 agonists in acute pulmonary embolism with insulin resistance and obesity: a proof-of-concept study.

Randomised controlled trial assessing the effect of GLP-1 agonists on biomarkers of vascular inflammation in patients with acute pulmonary embolism and insulin resistance and obesity


Sponsor

Western Sydney Local Health District

Enrollment

40 participants

Start Date

Nov 13, 2025

Study Type

Interventional

Conditions

Summary

Pulmonary embolism (blood clots in the lungs) is a common, potentially life-threatening condition affecting 50 to 75 per 100,000 people each year in Australia. The current long-term treatment of blood clots is limited to blood thinners alone, and there are no other studies investigating different treatment approaches. Mechanisms that determine persistence of blood clots in the lung blood vessels despite adequate blood thinning treatment remain unknown. Inflammation within the blood vessel walls following a blood clot seems to be an important driver of impaired clot resolution, but treatments targeting inflammation within the blood vessels are limited. Glucagon-like peptide-1 (GLP-1) agonists, which are commonly used in diabetes treatment, have prominent anti-inflammatory and blood vessel relaxation properties supporting their use in patients with lung blood clots at higher risk of worse outcomes. The purpose of this study is to test a novel treatment approach with a once-a-day medication (Liraglutide), in hospitalised patients with acute lung blood clots.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

A pulmonary embolism — a blood clot in the lungs — is a serious and potentially life-threatening condition. Current treatment focuses on blood thinners (anticoagulants), but some clots persist despite adequate treatment. Researchers believe that inflammation within the blood vessel walls may be a key reason why some clots do not resolve properly. GLP-1 agonists, a class of medication originally developed for diabetes (like the once-daily injection Liraglutide), have strong anti-inflammatory properties that might help. This proof-of-concept trial is testing whether adding Liraglutide to standard blood-thinner treatment in hospitalised patients with acute pulmonary embolism affects how well the clot resolves and how the heart recovers. It is a randomised, controlled study — meaning some participants will receive Liraglutide and some will receive standard care alone, chosen by chance. You may be eligible if you are 18 or older, have been hospitalised with an acute intermediate or high-risk pulmonary embolism, have already been started on blood-thinning treatment, and have evidence of right-sided heart strain on admission. People with serious heart or lung disease, or who are already taking GLP-1 medications, insulin, or sulfonylureas for diabetes, are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Liraglutide 0.6mg once daily subcutaneously for 5 days with standard of care anticoagulation for hospitalised patients with acute pulmonary embolism. The intervention medication will be administered b

Liraglutide 0.6mg once daily subcutaneously for 5 days with standard of care anticoagulation for hospitalised patients with acute pulmonary embolism. The intervention medication will be administered by the study investigators to ensure compliance. The standard of care anticoagulation treatment will be determined by the treating clinical team and the adherence will be monitored using medication charts.


Locations(1)

Westmead Hospital - Westmead

NSW, Australia

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