Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06118203 |
| Other study ID # |
300440 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2, 2022 |
| Est. completion date |
March 5, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Imperial College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Evaluation of circulating endothelial inflammatory biomarkers in response to GLP-1 agonist
Semaglutide in acute pulmonary embolism
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.
