Semaglutide Use in Acute Pulmonary Embolism

March 24, 2026 updated by: Imperial College London

Evaluation of Circulating Endothelial Inflammatory Biomarkers in Response to GLP-1 Agonist Semaglutide in Acute Pulmonary Embolism

Evaluation of circulating endothelial inflammatory biomarkers in response to GLP-1 agonist Semaglutide in acute pulmonary embolism

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Rationale and risk/benefit analysis

This GLP-1 intervention study in patients with acute PE represents an original hypothesis in a population with unmet clinical need. The results of this study could have important and immediate clinical implications in improving outcomes for this patient group. The current long-term treatment of acute PE is limited to anticoagulation, and there are no other studies investigating different treatment approaches. Vascular inflammation is known to be an important factor driving thrombus evolution and vascular remodelling, and therefore exploring the utility of targeting vascular inflammation is an important step forward in developing new treatment strategies for this common condition.

We aim to conduct a proof-of-concept open label study with biomarker response to evaluate Semaglutide, a GLP-1 agonist, administered as add-on therapy to the standard of care in adult patients with acute PE treated in hospital. Outcomes will be compared to a control group who will not receive the study drug. The study will recruit adult patients with proximal or large clot burden PE with evidence of right ventricular dysfunction on admission. This group has the highest risk of impaired clot resolution and of development of long-term complications including chronic thromboembolic disease.

There is a low risk of study drug complications given the extensive availability of human clinical trial data with GLP-1 agonists. There is also extensive real-world experience on the use of Semaglutide in the clinical investigation of glucose control in diabetes. As the first dose of the study drug is administered in hospital, clinical monitoring is optimised and common biochemical perturbations (hypoglycaemia) are easily interrogated and acted on by the clinical team. Patients who have contraindications to the use of GLP-1 agonists and patients currently taking GLP-1 agonists for diabetes mellitus are excluded to reduce the risks associated with the study drug even further.

Trial Objectives and Design

Trial Objectives

This proof-of-concept interventional study will comprise three separate but inter-linking aims:

I. Determine the effect of Semaglutide on highly glycosylated CD147- driven vascular inflammation in acute PE and GLP-1 receptor expression levels.

II. Evaluate immunological effects of Semaglutide in patients with acute PE (T cell receptor expression/cytokine, chemokine levels).

III. Determine the impact of Semaglutide on clot resolution and right ventricular recovery following acute PE.

4.2. Primary endpoints Evaluate the change in highly glycosylated CD147 between day 0 and following 6 weeks of Semaglutide.

4.3. Secondary endpoints I. Determine the rate of persistent CTPA or VQ scan perfusion defects with Semaglutide.

II. Change in right ventricular function, FAC andTASPE on echocardiography between day 0 and following 6 weeks of Semaglutide.

III. Change in plasma Cyclophylin A, sCD147, D-dimer, E selectin, VCAM, MMP levels, NTproBNP, GLP1-R, Troponin, myeloperoxidase activity.

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Acute admission with acute pulmonary embolism

Description

Inclusion Criteria:

Acute pulmonary embolism

Exclusion Criteria:

Concurrent use of GLP-1 agonist

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open label Semaglutide
Patients presenting with acute intermediate - high risk PE consenting to participation in drug arm of study
Drug: Semaglutide
Semaglutide in addition to standard of care
Other Names:
  • None applicable
Control
Patients presenting with acute intermediate - high risk PE consenting to participation in control arm of study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial biomarker measurement
Time Frame: 4 weeks
Change in plasma CD147 level between baseline and 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma proteomics
Time Frame: 4 weeks
Change in plasma proteome between baseline and 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Colm McCabe, MD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2022

Primary Completion (Actual)

March 4, 2023

Study Completion (Actual)

March 5, 2023

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300440

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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