Zibotentan and Dapagliflozin combination, Evaluated in Liver cirrhosis (ZEAL)
Research type
Research Study
Full title
A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Combination Compared to Zibotentan Monotherapy as well as Zibotentan/Dapagliflozin and Zibotentan Monotherapy Compared to Placebo in Participants withCirrhosis
IRAS ID
1008792
Contact name
Misha Ladva
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2023-506893-11
Research summary
Researchers are looking for a better way to treat cirrhosis. Cirrhosis is severe liver scarring and damage. Cirrhosis can cause portal hypertension. Portal hypertension is increased blood pressure within the portal vein and is the main cause of complications in people with cirrhosis.
Researchers think taking the trial drugs zibotentan and dapagliflozin could help treat cirrhosis and portal hypertension. Zibotentan taken on its own may decrease portal hypertension but could cause fluid retention in the body when taken alone. Fluid retention is when the body keeps too much fluid inside, causing fluids to build up in unwanted places. Dapagliflozin may help lower the risk of fluid retention caused by zibotentan and may also help treat the fluid retention caused by portal hypertension .
In this trial, researchers want to learn if dapagliflozin helps to reduce the risk of fluid retention in participants who are also taking zibotentan. They also want to learn if zibotentan with dapagliflozin, are safe and tolerable as compared to placebo. A placebo looks like a treatment but does not have any medicine in it.REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0421
Date of REC Opinion
7 Feb 2024
REC opinion
Further Information Favourable Opinion