A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants With Cirrhosis-ZEAL-UNLOCK

Part of paid clinical trials in Englewood, Colorado.

Sponsor
AstraZeneca
Study ID
NCT06269484
Phase
PHASE2
Status
Completed

Conditions

  • Liver Cirrhosis

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

Start date
Feb 15, 2024
Status verified
Jan 2026
Primary completion
Dec 11, 2024
Completion
Dec 11, 2024

Study Design

Enrollment
73 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Treatment Group 1
    Participants will receive once daily dose of placebo matching zibotentan capsule + placebo matching dapagliflozin tablet for 6 weeks
  • Experimental: Treatment Group 2
    Participants will receive once daily zibotentan capsule + placebo matching dapagliflozin tablet for 6 weeks
  • Experimental: Treatment Group 3
    Participants will receive once daily zibotentan capsule + dapagliflozin tablet 10 mg for 6 weeks

Primary Outcome Measure

Cumulative Number of Subjects With Any of the Components of the 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) [ Time Frame: baseline to Week 6 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteEnglewoodColorado80113-
Research SiteCharlestonSouth Carolina29425-
Research SiteSan AntonioTexas78215-

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