A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants with Cirrhosis-ZEAL-UNLOCK - ZEAL UNLOCK

Study identifier:D4326C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:2023-506893-11

Will Be Recruiting

Official Title

A Multicentre, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Combination Compared to Zibotentan Monotherapy, Zibotentan/Dapagliflozin and Zibotentan Monotherapy Compared to Placebo in Participants with Cirrhosis

Medical condition

liver cirrhosis

Phase

Phase 2

Healthy volunteers

No

Study drug

Placebo (placebo matching zibotentan capsule and placebo matching dapagliflozin tablet), Zibotentan + placebo (placebo matching dapagliflozin tablet), Zibotentan + dapagliflozin

Sex

All

Estimated Enrollment

66

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 15 Feb 2024
Estimated Primary Completion Date: 17 Jan 2025
Estimated Study Completion Date: 17 Jan 2025

Study design

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

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria