Study identifier:D4326C00004
ClinicalTrials.gov identifier:NCT06269484
EudraCT identifier:N/A
CTIS identifier:2023-506893-11
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
liver cirrhosis
Phase 2
No
Placebo (placebo matching zibotentan capsule and placebo matching dapagliflozin tablet), Zibotentan + placebo (placebo matching dapagliflozin tablet), Zibotentan + dapagliflozin
All
66
Interventional
18 Years - 80 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Treatment Group 1 Participants will receive once daily dose of placebo matching zibotentan capsule + placebo matching dapagliflozin tablet for 6 weeks | Drug: Placebo (placebo matching zibotentan capsule and placebo matching dapagliflozin tablet) placebo capsule (matching zibotentan capsule) placebo tablet (matching dapagliflozin tablet) |
Experimental: Treatment Group 2 Participants will receive once daily zibotentan capsule + placebo matching dapagliflozin tablet for 6 weeks | Drug: Zibotentan + placebo (placebo matching dapagliflozin tablet) zibotentan capsule placebo tablet (matching dapagliflozin tablet) |
Experimental: Treatment Group 3 Participants will receive once daily zibotentan capsule + dapagliflozin tablet 10 mg for 6 weeks | Drug: Zibotentan + dapagliflozin zibotentan capsule dapagliflozin 10 mg tablet |