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Zibotentan + Dapagliflozin for Liver Cirrhosis (ZEAL Trial)
ZEAL Trial Summary
This trial tests the safety, effectiveness and tolerability of two drugs to treat cirrhosis with features of portal hypertension.
ZEAL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ZEAL Trial Design
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Who is running the clinical trial?
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- I have a history of heart failure.My liver cirrhosis is due to long-term bile flow issues.I have a history of liver cancer.I have had bleeding from enlarged veins in my esophagus or stomach.I am not pregnant or breastfeeding.I haven't taken SGLT2 inhibitors or ERAs in the last month.I have liver damage due to medication or an infection.I have been treated for hepatitis C in the last year or started hepatitis B treatment less than a year ago.I have had surgery for permanent sterilization, not including tubal ligation.I am post-menopausal with no periods for 12 months and have hormone levels confirming this.I have had or will have a procedure to improve blood flow in my liver.I have had a liver transplant or expect to have one within 6 months.I have heart failure caused by conditions like hyperthyroidism or Paget's disease.I have been diagnosed with cirrhosis based on clinical or biopsy results.I am a woman who cannot become pregnant.I have been diagnosed with cirrhosis based on clinical exams or tissue analysis.My beta blocker dose has been stable for at least 1 month.My heart failure is not caused by specific conditions like amyloidosis or toxic effects.I have had severe brain function issues.I have had fluid build-up in my abdomen.I have had fluid in my chest due to liver problems.I have a history of portopulmonary syndrome.
- Group 1: Part A: Treatment Group 2
- Group 2: Part B: Treatment Group 1
- Group 3: Part B: Treatment Group 5
- Group 4: Part B: Treatment Group 2
- Group 5: Part B: Treatment Group 4
- Group 6: Part B: Treatment Group 3
- Group 7: Part A: Treatment Group 1
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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"
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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