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