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Study on the Safety of Zibotentan and Dapagliflozin for Patients with Liver Cirrhosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying cirrhosis, a condition where the liver becomes scarred and damaged. The study will evaluate the safety of two medications, Zibotentan and Dapagliflozin, both individually and in combination. Zibotentan is taken as a hard capsule, while Dapagliflozin is a film-coated tablet. The trial will also include a comparison with a placebo. The purpose of the study is to understand how these treatments affect fluid retention, body weight, and blood pressure in people with cirrhosis.

Participants in the study will receive either the combination of Zibotentan and Dapagliflozin, Zibotentan alone, or a placebo. The study will last for a period of six weeks, during which the effects of the treatments on body weight, body water volumes, and blood pressure will be monitored. The trial aims to see if the combination of medications can better manage symptoms compared to taking Zibotentan alone or a placebo.

Throughout the study, participants will be closely monitored for any changes in their condition, including any side effects or adverse events. The trial will help determine the safety and effectiveness of using Zibotentan and Dapagliflozin together for treating cirrhosis. This research could provide valuable insights into new treatment options for managing this liver condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be informed about the trial's objectives and procedures. The participant will provide informed consent, confirming understanding and agreement to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes a review of medical history and current health status, focusing on liver condition and any previous treatments.

  3. Step 3

    Randomization

    Participants will be randomly assigned to one of the study groups. This could involve receiving either the combination of zibotentan and dapagliflozin, zibotentan alone, or a placebo.

  4. Step 4

    Medication administration

    Participants will take the assigned medication orally. The specific dosage and frequency will be determined by the study protocol and communicated to the participant.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring will occur throughout the study. This includes checking body weight, body water volumes, and blood pressure. Participants will also report any side effects or changes in health.

  6. Step 6

    End of study evaluation

    At the end of the study period, a final evaluation will be conducted. This will assess the overall health of the participant and the effects of the medication.

Who can join the trial?

12 criteria

  • Participants must be between 18 and 80 years old.
  • Participants can be male or female, but females must not be able to have children. This means they must be post-menopausal (no periods for at least 12 months) or have had certain surgeries that prevent pregnancy.
  • Female participants must have a negative pregnancy test and must not be breastfeeding.
  • Participants must be able to understand and sign a consent form, agreeing to follow the study's rules and procedures.
  • Participants must have a diagnosis of **cirrhosis of the liver**, which means the liver is scarred and damaged. They should have certain signs like varices (swollen veins) or specific liver stiffness measurements.
  • Participants must have a **Model for End-Stage Liver Disease (MELD) score** of less than 15. This score helps to assess the severity of liver disease.
  • Participants must have a **Child-Pugh score** of less than 10. This score is used to measure liver function.
  • Participants should have no or mild fluid buildup in the abdomen (ascites) and should not have needed a procedure to remove this fluid in the last month.
  • Participants should not have any worsening of liver function in the last month, as determined by a doctor.
  • Participants should not be currently using or have used certain medications like **SGLT2 inhibitors** or **endothelin receptor antagonists** in the past month.
  • Participants should be on a stable dose of **beta blockers** (a type of heart medication) with no major changes in the last month.
  • Male participants must be surgically sterile, abstinent, or use effective birth control methods with their partners to prevent pregnancy during the study and for 3 months after. They should also use condoms and not donate sperm during this time.

Who cannot join the trial?

1 criterion

  • Patients with **cirrhosis of the liver**, which means the liver is scarred and damaged, cannot participate.
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Investigated drugs

  • Zibotentan

    is a medication being studied for its potential to help manage fluid retention in patients with cirrhosis. It is being tested both on its own and in combination with another medication to see how it affects body weight, body water volumes, and body fat mass. The study also looks at how it influences the use of other diuretics and blood pressure.

  • Dapagliflozin

    is another medication involved in the study, used in combination with zibotentan. It is being evaluated for its effectiveness in managing fluid retention and its impact on body weight, body water volumes, and body fat mass in patients with cirrhosis. The combination is also assessed for its effects on the use of other diuretics and blood pressure.

What is already known about the treatment

  • Zibotentan

    Zibotentan is administered orally and is currently being studied in clinical trials for its potential benefits in treating cirrhosis of the liver, a condition where the liver becomes scarred and damaged. It is being evaluated for its ability to manage fluid retention and improve body weight, water volumes, and fat mass in affected individuals. Zibotentan works by blocking endothelin receptors, which play a role in blood vessel constriction and fluid balance. It is classified as an endothelin receptor antagonist.

  • Dapagliflozin

    Dapagliflozin is taken orally and is under investigation in clinical trials for its use in combination with zibotentan to treat cirrhosis of the liver. The focus is on its effectiveness in reducing fluid retention and influencing body weight, water volumes, and fat mass. Dapagliflozin functions by inhibiting sodium-glucose co-transporter 2 (SGLT2), which helps reduce blood sugar levels and may have additional benefits in fluid management. It belongs to the class of SGLT2 inhibitors.

Investigated diseases

Cirrhosis of the liver – Cirrhosis of the liver is a condition in which the liver becomes scarred and damaged over time. This scarring is often the result of long-term liver damage from various causes, such as chronic alcohol use or viral hepatitis. As the liver tissue becomes increasingly scarred, it loses its ability to function properly. This can lead to complications like fluid retention, jaundice, and increased risk of infections. The progression of cirrhosis can vary, but it generally worsens over time if the underlying cause is not addressed. The liver's ability to regenerate is impaired, making it difficult for the organ to recover fully.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506893-11-00Protocol codeZEAL-UNLOCKEstimated enrolment66 patientsSponsorAstraZeneca AB

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