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SGLT2 Inhibitor

Zibotentan + Dapagliflozin for Liver Cirrhosis (ZEAL 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 and week 16
Awards & highlights

ZEAL Trial Summary

This trial tests the safety, effectiveness and tolerability of two drugs to treat cirrhosis with features of portal hypertension.

Who is the study for?
The ZEAL Study is for adults with liver cirrhosis and portal hypertension who haven't used SGLT2 inhibitors or endothelin receptor antagonists recently. They should have stable liver function, no recent severe kidney injury, variceal hemorrhage, or significant heart failure. Women must be non-pregnant, not breastfeeding, and either post-menopausal or surgically sterile.Check my eligibility
What is being tested?
This study tests the safety and effectiveness of combining zibotentan with dapagliflozin versus placebo in treating liver cirrhosis with portal hypertension. It's a double-blind trial meaning neither participants nor researchers know who gets the real treatment versus a placebo.See study design
What are the potential side effects?
Potential side effects may include typical drug reactions like nausea, headaches, possible kidney function changes due to dapagliflozin (a diabetes medication), and risks associated with zibotentan which could affect blood pressure since it targets blood vessel constriction.

ZEAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 6 and week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 6 and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Absolute change in HVPG from baseline to Week 6.
Part B: Absolute change in HVPG from baseline to Week 6.
Secondary outcome measures
Part A: Change in systolic and diastolic blood pressure from baseline to Week 6.
Part A: Change in total body water, extracellular water and intracellular water volumes from baseline to Week 6. Change in total body fat mass from baseline to Week 6.
Part A: Evaluation of change in body weight (kg) over time course of study. Percentage and absolute change from baseline in body weight at Week 6.
+9 more

ZEAL Trial Design

7Treatment groups
Experimental Treatment
Group I: Part B: Treatment Group 5Experimental Treatment1 Intervention
Participants will receive once daily dose of zibotentan capsule + dapagliflozin tablet for 16 weeks.
Group II: Part B: Treatment Group 4Experimental Treatment1 Intervention
Participants will receive once daily dose of zibotentan capsule + dapagliflozin tablet for 16 weeks.
Group III: Part B: Treatment Group 3Experimental Treatment1 Intervention
Participants will receive once daily dose of zibotentan capsule + dapagliflozin tablet for 16 weeks.
Group IV: Part B: Treatment Group 2Experimental Treatment1 Intervention
Participants will receive once daily dose of placebo matching zibotentan capsule + dapagliflozin tablet for 16 weeks.
Group V: Part B: Treatment Group 1Experimental Treatment1 Intervention
Participants will receive once daily dose of placebo matching zibotentan capsule + placebo matching dapagliflozin tablet for 16 weeks.
Group VI: Part A: Treatment Group 2Experimental Treatment1 Intervention
Participants will receive once daily dose of zibotentan capsule + dapagliflozin tablet for 6 weeks.
Group VII: Part A: Treatment Group 1Experimental Treatment1 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
4,261 Previous Clinical Trials
288,593,981 Total Patients Enrolled
1 Trials studying Liver Cirrhosis
66 Patients Enrolled for Liver Cirrhosis

Media Library

Dapagliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05516498 — Phase 2
Liver Cirrhosis Research Study Groups: Part A: Treatment Group 2, Part B: Treatment Group 1, Part B: Treatment Group 5, Part B: Treatment Group 2, Part B: Treatment Group 4, Part B: Treatment Group 3, Part A: Treatment Group 1
Liver Cirrhosis Clinical Trial 2023: Dapagliflozin Highlights & Side Effects. Trial Name: NCT05516498 — Phase 2
Dapagliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05516498 — Phase 2
Liver Cirrhosis Patient Testimony for trial: Trial Name: NCT05516498 — Phase 2

Frequently Asked Questions

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

How many individuals are partaking in the evaluation of this medication?

"Affirmative. Clinicaltrials.gov data indicates that this clinical trial is currently accepting applications, which were first posted on October 31st 2022 and more recently modified on November 21st 2022. The study requires participants from 8 distinct sites for a total of 140 patients."

Answered by AI

Are younger individuals eligible to register for this experiment?

"This medical study is seeking participants between the ages of 18 and 80, providing 76 opportunities for younger patients, and 412 potential spots for those aged 65 or above."

Answered by AI

Has Part A: Treatment Group 1 been granted approval by the Food and Drug Administration?

"After rigorous assessment, our team at Power determined the safety of Part A: Treatment Group 1 to be a 2. This Phase 2 trial has collected evidence that suggests it is safe but none supporting its efficacy."

Answered by AI

How many healthcare facilities are currently partaking in this research endeavor?

"At the moment, 8 distinct medical centers are enrolling participants for this clinical trial. These locations are located in Charleston, Rochester and San Diego among various other cities. To reduce travelling burdens, it is suggested that you select a site closest to your residence if you plan on joining the experiment."

Answered by AI

Who is eligible to partake in the research study?

"This medical trial is seeking out 140 individuals, between the ages of 18 and 80 who have been diagnosed with liver cirrhosis. Furthermore, these potential participants must meet a variety of criteria such as not having taken any SGLT2 inhibitors or endothelin receptor antagonists within 30 days prior to enrolment; being on either no or a stable dose of beta blockers without major changes in dosage over the past month; verifying post-menopausal status through documentation and testing; confirmation that they are unable to bear children via hysterectomy or bilateral oophorectomy/salpingectomy (not tubal ligation); possessing Child"

Answered by AI

What is the primary aim of this investigation?

"According to the trial sponsor, AstraZeneca, the primary outcome of this experiment will be Part B: HVPG response. Wherein a responder is defined as at least 20% decrease or reduction to 12 mmHg in HVPG from baseline to Week 6. The subsidiary outcomes that researchers are assessing include changes in total body water and fat mass volumes, percentage and absolute change of loop-diuretic equivalents use from baseline to Week 6., and also percentages/absolute change of HVGP from baseline until week six."

Answered by AI

Are there any ongoing enlistments for this particular clinical investigation?

"According to clinicaltrials.gov, this experiment is actively recruiting subjects. The trial was initially published on October 31st 2022 and recently edited on November 21st 2022."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
South Carolina
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’ve been told my liver was in bad shape . I previously had hep-c and was effectively treated with maverick antiviral treatment which worked But there was a lot of damage done. Would like to get help to fix this condition.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Is there financial incentive to do this study? To compensate for travel costs and other expenses?
PatientReceived 2+ prior treatments
~67 spots leftby Jan 2025