Study identifier:D4326C00003
ClinicalTrials.gov identifier:NCT05516498
EudraCT identifier:2021-006577-30
CTIS identifier:2023-505405-17-00
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
liver cirrhosis
Phase 2
No
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
All
195
Interventional
18 Years - 80 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Screening
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Part A: Treatment Group 1 Participants will receive once daily dose of placebo matching zibotentan capsule + placebo matching dapagliflozin tablet for 6 weeks. | Drug: Part A: Placebo (matching zibotentan capsule & matching dapagliflozin tablet) placebo capsule (matching zibotentan capsule) placebo tablet (matching dapagliflozin tablet) |
Experimental: Part A: Treatment Group 2 Participants will receive once daily dose of zibotentan capsule + dapagliflozin tablet for 6 weeks. | Drug: Part A: zibotentan (dose B) + dapagliflozin zibotentan capsule dapagliflozin tablet |
Experimental: Part B: Treatment Group 1 Participants will receive once daily dose of placebo matching zibotentan capsule + placebo matching dapagliflozin tablet for 16 weeks. | Drug: Part B: Placebo (matching zibotentan capsule & matching dapagliflozin tablet) placebo capsule (matching zibotentan capsule) placebo tablet (matching dapagliflozin tablet) |
Experimental: Part B: Treatment Group 2 Participants will receive once daily dose of placebo matching zibotentan capsule + dapagliflozin tablet for 16 weeks. | Drug: Part B: placebo (matching zibotentan capsule) + dapagliflozin placebo capsule (matching zibotentan capsule) dapagliflozin tablet |
Experimental: Part B: Treatment Group 3 Participants will receive once daily dose of zibotentan capsule + dapagliflozin tablet for 16 weeks. | Drug: Part B: zibotentan (dose A) + dapagliflozin zibotentan capsule dapagliflozin tablet |
Experimental: Part B: Treatment Group 4 Participants will receive once daily dose of zibotentan capsule + dapagliflozin tablet for 16 weeks. | Drug: Part B: zibotentan (dose B) + dapagliflozin zibotentan capsule dapagliflozin tablet |
Experimental: Part B: Treatment Group 5 Participants will receive once daily dose of zibotentan capsule + dapagliflozin tablet for 16 weeks. | Drug: Part B: zibotentan (dose C) + dapagliflozin zibotentan capsule dapagliflozin tablet |