Zibotentan and Dapagliflozin Combination, EvAluated in Liver Cirrhosis (ZEAL Study)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT05516498
Phase
PHASE2
Status
Terminated

Conditions

  • Liver Cirrhosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a two part Phase IIa/b multicentre, randomised, double-blind, placebo-controlled, parallel group dose-ranging study to assess the 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.

Key Dates

Start date
Oct 31, 2022
Status verified
Aug 2025
Primary completion
May 22, 2025
Completion
Jul 17, 2025

Study Design

Enrollment
205 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Part A: Treatment Group 1
    Participants will receive once daily dose of placebo matching zibotentan capsule + placebo matching dapagliflozin tablet for 6 weeks.
  • Experimental: Part A: Treatment Group 2
    Participants will receive once daily dose of zibotentan capsule + dapagliflozin tablet for 6 weeks.
  • Experimental: Part B: Treatment Group 1
    Participants will receive once daily dose of placebo matching zibotentan capsule + placebo matching dapagliflozin tablet for 16 weeks.
  • Experimental: Part B: Treatment Group 2
    Participants will receive once daily dose of placebo matching zibotentan capsule + dapagliflozin tablet for 16 weeks.
  • Experimental: Part B: Treatment Group 3
    Participants will receive once daily dose of zibotentan capsule + dapagliflozin tablet for 16 weeks.
  • Experimental: Part B: Treatment Group 4
    Participants will receive once daily dose of zibotentan capsule + dapagliflozin tablet for 16 weeks.
  • Experimental: Part B: Treatment Group 5
    Participants will receive once daily dose of zibotentan capsule + dapagliflozin tablet for 16 weeks.

Primary Outcome Measure

Part A: Absolute change in HVPG from baseline to Week 6. [ Time Frame: at Week 6 ]

Locations (11)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35233-
Research SitePasadenaCalifornia91105-
Research SiteSan FranciscoCalifornia94115-
Research SiteWest HollywoodCalifornia90048-
Research SiteRochesterMinnesota55905-
Research SiteThe BronxNew York10467-
Research SiteCharlestonSouth Carolina29425-
Research SiteDallasTexas75246-
Research SiteCharlottesvilleVirginia22903-
Research SiteRichmondVirginia23249-
Research SiteMilwaukeeWisconsin53226-

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By research site
Research Site· Birmingham, ALResearch Site· Pasadena, CAResearch Site· San Francisco, CAResearch Site· West Hollywood, CAResearch Site· Rochester, MNResearch Site· The Bronx, NY

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