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SGLT2 Inhibitor

Treatment Group 3 for Liver Cirrhosis (ZEAL UNLOCK Trial)

Phase 2
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 and ≤ 80 years of age at the time of signing the informed consent
Not on SGLT2 inhibitor or endothelin receptor antagonist
Screening 3 weeks
Treatment Varies
Follow Up at week 6
Awards & highlights

ZEAL UNLOCK Trial 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.

ZEAL UNLOCK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am between 18 and 80 years old.
I am not taking SGLT2 inhibitors or endothelin receptor antagonists.
I am not taking beta blockers or my dose has been stable.
I am not able to have children and meet the contraceptive requirements.
My liver function has not worsened in the past month.
I have been diagnosed with cirrhosis showing specific signs of worsening or stable condition with certain complications.
My liver function is relatively good.

ZEAL UNLOCK Trial 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

ZEAL UNLOCK 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
4,259 Previous Clinical Trials
288,593,836 Total Patients Enrolled
1 Trials studying Liver Cirrhosis
195 Patients Enrolled for Liver Cirrhosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being actively recruited for participation in this study?

"Indeed, information from clinicaltrials.gov shows that this research is actively seeking participants. It was initially posted on February 15th, 2024 and most recently updated on March 22nd, 2024. The study aims to enroll a total of 66 patients distributed among 41 different sites."

Answered by AI

Who would be the ideal candidate to participate in this medical study?

"This clinical trial aims to enroll 66 individuals aged between 18 and 80 with a current diagnosis of liver cirrhosis. In order to be eligible, patients must not have experienced any deterioration in hepatic function within the month leading up to dosing, as confirmed by the investigator or regular healthcare provider. They should also not have received treatment with an SGLT2 inhibitor or endothelin receptor antagonist within a month before enrollment. Additionally, participants must exhibit signs of compensated cirrhosis with features of CSPH (such as varices observed during endoscopy), elevated liver stiffness (>25 kPa or >21 kPa) alongside"

Answered by AI

How many individuals are anticipated to participate in this research?

"Indeed, the information available on clinicaltrials.gov indicates that this research project is actively searching for eligible participants. The trial was first listed on February 15th, 2024 and last revised on March 22nd, 2024. A total of 66 individuals are sought from a network of 41 sites."

Answered by AI

At how many different sites is this clinical trial currently being conducted?

"At present, 41 medical facilities are enrolling participants for this study. The trial sites can be found in various places such as Yokohama-shi, Plzeň, and Milano among other locations worldwide. Opting for the site nearest to your location is advisable to reduce travel requirements during your participation."

Answered by AI

Is the clinical trial open to participants below 85 years of age?

"Participants between the ages of 18 and up to 80 years old are eligible for enrollment based on the trial's inclusion criteria."

Answered by AI

Has the FDA officially endorsed Treatment Group 3 for therapeutic use?

"According to Power's assessment, the safety rating for Treatment Group 3 is a moderate 2 on a scale of 1 to 3. This evaluation is based on Phase 2 trial data that indicates some evidence supporting safety but lacks efficacy data."

Answered by AI
~44 spots leftby Jan 2025