The purpose of this study is to learn more about the effects of 2 drugs, zibotentan and dapagliflozin, in people with liver disease (cirrhosis) with features of increased pressure in portal veins (portal hypertension). The study also aims to better understand this disease and associated health problems. Cirrhosis is the end-stage of chronic liver disease and slows the blood flow through the liver, which causes increased pressure in portal veins known as portal hypertension. Zibotentan works by blocking the effect of the hormone that causes the narrowing of blood vessels, which may thereby prevent complications of liver disease. Dapagliflozin reduces water accumulating in the body, which helps to maintain the overall health of the body. Researchers aim to measure the effect of zibotentan in combination with dapagliflozin on lowering blood pressure in the liver veins in these patients, in addition to assessing the drugs’ safety and tolerability. Participants will be randomly assigned to receive the combination of zibotentan with dapagliflozin or placebo (inactive substance). Zibotentan is an experimental drug; dapagliflozin is approved by the U.S. Food and Drug Administration (FDA) to treat various conditions, but its use in this study is investigational.
What is the full name of this clinical trial?
A Two Part Phase IIa/b Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose-ranging Study to Assess Efficacy, Safety, and Tolerability of the Combination of Zibotentan and Dapagliflozin, and Dapagliflozin Monotherapy Versus Placebo in Participants with Cirrhosis with Features of Portal Hypertension
Liver cirrhosis, Portal hypertension
Ju Dong Yang, Walid Ayoub