drugset / Trial / NCT04073797

PET Imaging of Inflammation and Lipid Lowering Study

NCT04073797

RandomizedParallel-groupQuadruple-blindDiagnostic

Summary

While 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging has been used as an early marker of drug efficacy in numerous clinical cardiovascular drug trials, as a glucose analog, its signal in the vasculature lacks inflammatory cell-specificity. Moreover, high background 18F-FDG signals from the myocardium often preclude coronary artery imaging, despite attempts to suppress myocardial tracer uptake by dietary manipulation. These limitations of 18F-FDG for measuring changes in vascular inflammation arising from drug intervention highlight important unmet needs, which might be overcome by using a somatostatin receptor subtype-2 (SST2) PET tracer.

Timeline

Start
2023-03-20
Primary completion
2025-10-01
Completion
2026-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Colchicine Small molecule 500 ug
Subject Inclisiran Small interfering RNA (siRNA) 284 mg