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
Brief description of study
The main purpose of this study is to learn more about the effects of two drugs called zibotentan and dapagliflozin, in patients with liver disease (cirrhosis) with features of increased pressure in portal veins (portal hypertension) and also to better understand the studied disease and associated health problems. This study consists of two parts:
- Part A will assess the efficacy, safety, and tolerability of the combination of 2.5 mg zibotentan and 10 mg dapagliflozin versus placebo in participants with Child-Pugh A cirrhosis with features of portal hypertension and with no history of decompensation events.
- Part B will investigate efficacy, safety, and tolerability of 1, 2.5, or 5 mg zibotentan combined with 10 mg dapagliflozin and of 10 mg dapagliflozin monotherapy versus placebo in participants with cirrhosis with features of portal hypertension. Part B will include a broader range of Child- Pugh A and Child-Pugh B cirrhosis participants, including those with more severe disease, a history of decompensation events, or current ascites.
Clinical Study Identifier: s22-01533
ClinicalTrials.gov Identifier: NCT05516498
Principal Investigator:
Ira M. Jacobson.
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