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

Study identifier:D4326C00003

ClinicalTrials.gov identifier:NCT05516498

EudraCT identifier:2021-006577-30

CTIS identifier:2023-505405-17-00

Recruiting

Official 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

Medical condition

liver cirrhosis

Phase

Phase 2

Healthy volunteers

No

Study drug

Part A: Placebo (matching zibotentan capsule & matching dapagliflozin tablet), Part A: zibotentan (dose B) + dapagliflozin, Part B: Placebo (matching zibotentan capsule & matching dapagliflozin tablet), Part B: placebo (matching zibotentan capsule) + dapagliflozin, Part B: zibotentan (dose A) + dapagliflozin, Part B: zibotentan (dose B) + dapagliflozin, Part B: zibotentan (dose C) + dapagliflozin

Sex

All

Estimated Enrollment

195

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 31 Oct 2022
Estimated Primary Completion Date: 22 Jan 2025
Estimated Study Completion Date: 16 Apr 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Screening

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria