Zibotentan and Dapagliflozin, and Dapagliflozin Monotherapy in Cirrhosis

What is the Purpose of this Study?

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.


Eligibility

  • 1. No current or prior (within 1 month of enrolment) medical treatment with an SGLT2 inhibitor or ERAs.
  • 2. On no or a stable dose of beta blockers, with no major dose changes within 1 month prior to the first dose of study intervention.
  • 3. Provision of signed and dated, written ICF prior to any mandatory study-specific procedures, sampling, and analyses.
  • 4. Female participants of non-childbearing potential confirmed at screening by fulfilling one of the following criteria:
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Where can I participate?

Beverly

More about this Clinical Trial

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

Study Details
Disease Type/Condition

Liver cirrhosis, Portal hypertension

Principal Investigator

Kuo, Alexander

Co-Investigators

Ju Dong Yang, Walid Ayoub

Age Group

Adult

Phase

II

IRB Number

STUDY00002494

ClinicalTrials.gov ID

NCT05516498

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Liver cirrhosis, Portal hypertension

Principal Investigator

Kuo, Alexander

Age Group

Adult

Phase

II

IRB Number

D4326C00003

ClinicalTrials.gov ID

NCT05516498

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org