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SGLT2 Inhibitor

Zibotentan + Dapagliflozin for Liver Cirrhosis (ZEAL UNLOCK Trial)

Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 6
Awards & highlights

Summary

This trial is testing the safety of a combination of two drugs, zibotentan and dapagliflozin, in patients with cirrhosis. The study will compare the safety of this

Who is the study for?
This trial is for adults aged 18-80 with a clinical or histological diagnosis of cirrhosis, but stable liver function and no recent treatments that could affect the study. They must not have severe liver disease (MELD < 15, Child-Pugh < 10), significant ascites, or changes in certain medications recently. Men must agree to contraception use.Check my eligibility
What is being tested?
The ZEAL-UNLOCK trial is testing the safety of combining zibotentan with dapagliflozin versus zibotentan alone and against a placebo in patients with cirrhosis. Participants are randomly assigned to one of these groups without knowing which they're receiving.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to zibotentan or dapagliflozin such as blood pressure changes, kidney function alterations, possible risk of dehydration, and issues related to liver condition worsening.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)
Secondary outcome measures
Absolute change in systolic and diastolic blood pressure
Change from baseline in body fat mass
Change from baseline in body weight
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Group 3Experimental Treatment1 Intervention
Participants will receive once daily zibotentan capsule + dapagliflozin tablet 10 mg for 6 weeks
Group II: Treatment Group 2Experimental Treatment1 Intervention
Participants will receive once daily zibotentan capsule + placebo matching dapagliflozin tablet for 6 weeks
Group III: Treatment Group 1Placebo Group1 Intervention
Participants will receive once daily dose of placebo matching zibotentan capsule + placebo matching dapagliflozin tablet for 6 weeks

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,302 Previous Clinical Trials
288,624,533 Total Patients Enrolled
1 Trials studying Liver Cirrhosis
195 Patients Enrolled for Liver Cirrhosis
~30 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
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