Pulmonary EmbolismNCT06118203
Semaglutide Use in Acute Pulmonary Embolism
An observational study of Pulmonary Embolism, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Evaluation of circulating endothelial inflammatory biomarkers in response to GLP-1 agonist Semaglutide in acute pulmonary embolism Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Semaglutide
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jan 2022to 5 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute admission with acute pulmonary embolism
Who may be able to join
- Acute pulmonary embolism
Who cannot join
- Concurrent use of GLP-1 agonist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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:
- 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.
- Conditions
- Pulmonary Embolism
- Being tested
- Semaglutide
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called None applicable
Semaglutide in addition to standard of care
| Study group | Role | What they receive |
|---|---|---|
| Open label Semaglutide | Patients presenting with acute intermediate - high risk PE consenting to participation in drug arm of study Receives: Drug: Semaglutide | |
| Control | Patients presenting with acute intermediate - high risk PE consenting to participation in control arm of study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial biomarker measurement
Change in plasma CD147 level between baseline and 4 weeks
Measured: 4 weeks
Secondary outcomes (1)
Plasma proteomics
Change in plasma proteome between baseline and 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start2 Jan 2022
- Primary completion4 Mar 2023
- Study completion5 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colm McCabe, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118203
- Sponsor's protocol ID
- 300440
- Status last verified
- Mar 2026
- First submitted
- 11 Sep 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Samaranayake CB, Chen YC, Fang M, Rhodes CJ, Song S, Sabrin F, Ashek A, Bonnici K, Mukherjee B, Howard LS, Pinguel J, Rawal B, Semple T, Price LC, Wort SJ, Rudd T, Zhao L, McCabe C. GLP-1 agonist, semaglutide use in acute pulmonary embolism recovery: a four-week proof-of-concept study including proteomic profiling. Eur Heart J Open. 2025 Dec 24;6(1):oeaf170. doi: 10.1093/ehjopen/oeaf170. eCollection 2026 Jan.
PubMed 41536961
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Circulating Endothelial Inflammatory Biomarkers in Response to GLP-1 Agonist Semaglutide in Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT06118203
- Acronym / sponsor ID
- 300440
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 5 Mar 2023 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of circulating endothelial inflammatory biomarkers in response to GLP-1 agonist Semaglutide in acute pulmonary embolism
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:
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open label Semaglutide | – | Drug: SemaglutidePatients presenting with acute intermediate - high risk PE consenting to participation in drug arm of study |
| Control | – | –Patients presenting with acute intermediate - high risk PE consenting to participation in control arm of study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute admission with acute pulmonary embolism
Key inclusion criteria (1 listed)
- Acute pulmonary embolism
Key exclusion criteria (1 listed)
- Concurrent use of GLP-1 agonist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAlso: None applicableSemaglutide in addition to standard of care | Drug | Open label Semaglutide |
Primary outcome
Endothelial biomarker measurement
Time frame: 4 weeks
Change in plasma CD147 level between baseline and 4 weeks
1 secondary outcome
Plasma proteomics
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 41536961Samaranayake CB, Chen YC, Fang M, Rhodes CJ, Song S, Sabrin F, Ashek A, Bonnici K, Mukherjee B, Howard LS, Pinguel J, Rawal B, Semple T, Price LC, Wort SJ, Rudd T, Zhao L, McCabe C. GLP-1 agonist, semaglutide use in acute pulmonary embolism recovery: a four-week proof-of-concept study including proteomic profiling. Eur Heart J Open. 2025 Dec 24;6(1):oeaf170. doi: 10.1093/ehjopen/oeaf170. eCollection 2026 Jan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colm McCabe, MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Imperial College London at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Mar 2026. 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 United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial biomarker measurement (time frame: 4 weeks). 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 NCT06118203, which also lists 1 linked publication.
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 27 Mar 2026.