AstraZeneca_Zibotentan and Dapagliflozin combination, EvAluated in Liver cirrhosis (ZEAL study)

Summary

Part A Objectives Primary Objective: To evaluate the change from baseline in HVPG on zibotentan and dapagliflozin in combination versus placebo. Secondary Objectives: - To evaluate the proportion of participants achieving HVPG < 10 mmHg or a reduction in HVPG of ? 1.5 mmHg on zibotentan and dapagliflozin versus placebo. - To evaluate the effect of zibotentan and dapagliflozin in combination versus placebo on change in body weight. - To evaluate the effect of zibotentan and dapagliflozin in combination versus placebo on accumulated additional loop-diuretic equivalents use. - To evaluate the effect of zibotentan and dapagliflozin in combination versus placebo on body water volumes and body fat mass. - in combination versus placebo on changes in office-based systolic and diastolic blood pressure. Safety Objective: To assess the safety and tolerability of zibotentan and dapagliflozin in combination versus placebo. Part B Objectives Primary Objective: To evaluate the proportion of participants achieving at least 20% decrease in HVPG or a reduction to or below 12 mmHg in HVPG on zibotentan and dapagliflozin in combination and dapagliflozin monotherapy versus placebo. Secondary Objectives: - To evaluate the change from baseline in HVPG on zibotentan and dapagliflozin in combination and dapagliflozin monotherapy versus placebo. - To evaluate the effect of zibotentan and dapagliflozin in combination and dapagliflozin monotherapy versus placebo on change in body weight. - To evaluate the effect of zibotentan and dapagliflozin in combination and dapagliflozin monotherapy versus placebo on accumulated additional loop-diuretic equivalents use. - To evaluate the effect of zibotentan and dapagliflozin in combination and dapagliflozin monotherapy versus placebo on body water volumes and body fat mass. - To evaluate the effect of zibotentan and dapagliflozin in combination and dapagliflozin monotherapy versus placebo on changes in office-based systolic and diastolic blood pressure. Safety Objective: To assess the safety and tolerability of zibotentan and dapagliflozin in combination and dapagliflozin monotherapy versus placebo.


Inclusion Criteria

  • No current or prior (within 1 month of enrolment) medical treatment with an SGLT2 inhibitor or endothelin receptor antagonist.
  • 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.
  • Provision of signed and dated, written ICF prior to any mandatory study-specific procedures, sampling, and analyses.
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

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

Details
Disease Type/Condition

Other

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

Contact
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

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
Want to join the study or
learn more?