nctId: NCT06269484 id: D4326C00004 briefTitle: A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants With Cirrhosis-ZEAL-UNLOCK acronym: ZEAL UNLOCK overallStatus: RECRUITING date: 2024-02-15 date: 2025-01-17 date: 2025-01-17 date: 2024-02-21 date: 2024-03-25 name: AstraZeneca class: INDUSTRY briefSummary: This is a Phase IIb multicentre, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the safety of zibotentan/dapagliflozin in combination as compared to zibotentan monotherapy as well as zibotentan/dapagliflozin and zibotentan monotherapy as compared to placebo in patients with cirrhosis. conditions: Liver Cirrhosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 66 type: ESTIMATED name: Placebo (placebo matching zibotentan capsule and placebo matching dapagliflozin tablet) name: Zibotentan + placebo (placebo matching dapagliflozin tablet) name: Zibotentan + dapagliflozin measure: Occurence of any of the following components of this composite endpoint: >2kg increase in body weight (office-based), >2 L increase in total body water, increase in 2 or more loop-diuretic equivalents, fluid retention adverse event (AE) measure: Occurence of any of the following components of this composite endpoint: >2kg increase in body weight (office-based), >2 L increase in total body water, increase in 2 or more loop-diuretic equivalents, fluid retention adverse event (AE) measure: Change in body weight (kg) over time course of study measure: Change in body weight (kg) over time course of study measure: Change in total dosage of loop-diuretic equivalents use measure: Change in total dosage of loop-diuretic equivalents use measure: Occurence of either of the two components of this composite: 1. >3 L increase in total body water volume from baseline to Week 6 2. Increase in 3 or more loop-diuretics equivalents use measure: Occurence of either of the two components of this composite: 1. >3 L increase in total body water volume from baseline to Week 6 2. Increase in 3 or more loop-diuretics equivalents use measure: Absolute change in systolic and diastolic blood pressure measure: Absolute change in systolic and diastolic blood pressure measure: Change from baseline in body weight measure: Change from baseline in total body water measure: Change from baseline in extracellular water volume measure: Change from baseline in intracellular water volume measure: Change from baseline in body fat mass measure: Change from baseline in body weight measure: Change from baseline in total body water measure: Change from baseline in extracellular water volume measure: Change from baseline in intracellular water volume measure: Change from baseline in body fat mass sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Englewood state: Colorado zip: 80113 country: United States lat: 39.64777 lon: -104.98776 facility: Research Site status: NOT_YET_RECRUITING city: Charleston state: South Carolina zip: 29425 country: United States lat: 32.77657 lon: -79.93092 facility: Research Site status: RECRUITING city: San Antonio state: Texas zip: 78215 country: United States lat: 29.42412 lon: -98.49363 facility: Research Site status: NOT_YET_RECRUITING city: Adelaide zip: 5000 country: Australia lat: -34.92866 lon: 138.59863 facility: Research Site status: NOT_YET_RECRUITING city: Kogarah zip: 2217 country: Australia lat: -33.98333 lon: 151.11667 facility: Research Site status: NOT_YET_RECRUITING city: Mitcham zip: 3132 country: Australia lat: -37.81667 lon: 145.2 facility: Research Site status: NOT_YET_RECRUITING city: Edegem zip: 2650 country: Belgium lat: 51.15662 lon: 4.44504 facility: Research Site status: NOT_YET_RECRUITING city: Mechelen zip: 2800 country: Belgium lat: 51.02574 lon: 4.47762 facility: Research Site status: NOT_YET_RECRUITING city: Liberec zip: 460 63 country: Czechia lat: 50.76711 lon: 15.05619 facility: Research Site status: NOT_YET_RECRUITING city: Mladá Boleslav zip: 293 01 country: Czechia lat: 50.41135 lon: 14.90318 facility: Research Site status: NOT_YET_RECRUITING city: Plzeň zip: 323 00 country: Czechia lat: 49.74747 lon: 13.37759 facility: Research Site status: NOT_YET_RECRUITING city: Praha 4 zip: 140 21 country: Czechia lat: 50.08804 lon: 14.42076 facility: Research Site status: NOT_YET_RECRUITING city: Aachen zip: 52074 country: Germany lat: 50.77664 lon: 6.08342 facility: Research Site status: NOT_YET_RECRUITING city: Kiel zip: 24146 country: Germany lat: 54.32133 lon: 10.13489 facility: Research Site status: NOT_YET_RECRUITING city: Leipzig zip: 04103 country: Germany lat: 51.33962 lon: 12.37129 facility: Research Site status: NOT_YET_RECRUITING city: Tuebingen zip: 72076 country: Germany lat: 48.52266 lon: 9.05222 facility: Research Site status: NOT_YET_RECRUITING city: Milano zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 facility: Research Site status: NOT_YET_RECRUITING city: Padova zip: 35128 country: Italy lat: 45.40797 lon: 11.88586 facility: Research Site status: NOT_YET_RECRUITING city: Roma zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 facility: Research Site status: NOT_YET_RECRUITING city: Gifu-shi zip: 500-8513 country: Japan lat: 35.42291 lon: 136.76039 facility: Research Site status: RECRUITING city: Iizuka-shi zip: 820-8505 country: Japan lat: 33.63654 lon: 130.68678 facility: Research Site status: NOT_YET_RECRUITING city: Kawasaki-shi zip: 215-0026 country: Japan lat: 35.52056 lon: 139.71722 facility: Research Site status: NOT_YET_RECRUITING city: Kitakyusyu-shi zip: 806-8501 country: Japan facility: Research Site status: RECRUITING city: Nagaoka-shi zip: 940-2085 country: Japan lat: 37.45 lon: 138.85 facility: Research Site status: RECRUITING city: Niigata-shi zip: 951-8520 country: Japan lat: 37.88637 lon: 139.00589 facility: Research Site status: NOT_YET_RECRUITING city: Sapporo-shi zip: 006-8555 country: Japan lat: 43.06667 lon: 141.35 facility: Research Site status: NOT_YET_RECRUITING city: Yokohama-shi zip: 236-0004 country: Japan lat: 35.43333 lon: 139.65 facility: Research Site status: NOT_YET_RECRUITING city: Bydgoszcz zip: 85-794 country: Poland lat: 53.1235 lon: 18.00762 facility: Research Site status: NOT_YET_RECRUITING city: Katowice zip: 40-081 country: Poland lat: 50.25841 lon: 19.02754 facility: Research Site status: NOT_YET_RECRUITING city: Kraków zip: 31-513 country: Poland lat: 50.06143 lon: 19.93658 facility: Research Site status: NOT_YET_RECRUITING city: Mysłowice zip: 41-400 country: Poland lat: 50.20745 lon: 19.16668 facility: Research Site status: NOT_YET_RECRUITING city: Poznań zip: 61-848 country: Poland lat: 52.40692 lon: 16.92993 facility: Research Site status: NOT_YET_RECRUITING city: Wrocław zip: 52-210 country: Poland lat: 51.1 lon: 17.03333 facility: Research Site status: NOT_YET_RECRUITING city: Bratislava zip: 83104 country: Slovakia lat: 48.14816 lon: 17.10674 facility: Research Site status: NOT_YET_RECRUITING city: Nitra zip: 950 01 country: Slovakia lat: 48.30763 lon: 18.08453 facility: Research Site status: NOT_YET_RECRUITING city: Trnava zip: 91702 country: Slovakia lat: 48.37741 lon: 17.58723 facility: Research Site status: NOT_YET_RECRUITING city: Aberdeen zip: AB25 2ZN country: United Kingdom lat: 57.14369 lon: -2.09814 facility: Research Site status: NOT_YET_RECRUITING city: Hull zip: HU3 2KZ country: United Kingdom lat: 53.7446 lon: -0.33525 facility: Research Site status: NOT_YET_RECRUITING city: Ipswich zip: IP4 5PD country: United Kingdom lat: 52.05917 lon: 1.15545 facility: Research Site status: NOT_YET_RECRUITING city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: Nottingham zip: NG7 2UH country: United Kingdom lat: 52.9536 lon: -1.15047 hasResults: False