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

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 6

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Absolute change in systolic and diastolic blood pressure

Change from baseline in body fat mass

Change from baseline in body weight

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