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Zibotentan

Clinical trials are studying Zibotentan in people with liver cirrhosis and in people with chronic kidney disease and high proteinuria. These studies look at whether Zibotentan, alone or with dapagliflozin, can improve disease measures and safety outcomes. They include Phase 2 and Phase 3 research in different patient groups.

Table of contents

Clinical trials overview

The trial data describe three interventional studies of Zibotentan, meaning the treatment is given to people and then compared with another group.[1][2][3] Two studies are in liver disease, and one study is in kidney disease.[1][2][3] The studies include Phase 2, Phase 2b, and Phase 3 research, so they range from earlier testing to a larger confirmatory trial.[1][2][3]

Studies in liver cirrhosis

One completed Phase 2 study, called the ZEAL study, looked at people with liver cirrhosis and features of portal hypertension, which means high pressure in the blood vessels that go to the liver.[1] This study compared Zibotentan and dapagliflozin in combination with placebo, and its main goal was to see the change in HVPG from baseline to Week 6.[1] HVPG stands for hepatic venous pressure gradient, a test that helps show pressure in the liver blood flow system.[1]

A second completed Phase 2b study, ZEAL-UNLOCK, looked at people with cirrhosis of the liver and focused on safety.[2] The study examined Zibotentan and dapagliflozin, Zibotentan alone, and placebo groups, with attention to fluid retention, which means the body holding extra fluid and possibly causing weight gain or swelling.[2] The main outcomes included body weight, total body water, body fat mass, blood pressure, and use of loop-diuretic equivalents over 6 weeks.[2]

Study in chronic kidney disease

The Phase 3 study, NCT06087835, is authorised and is testing Zibotentan combined with dapagliflozin in people with chronic kidney disease and high proteinuria, which means too much protein in the urine.[3] The study compares the fixed-dose combination with dapagliflozin alone and includes a large enrollment of 1833 people.[3] Its main outcome is the change in eGFR from baseline to Month 24, which shows how well the kidneys are filtering blood.[3]

What researchers measure

In the liver cirrhosis studies, researchers focus on pressure in the liver circulation and on signs of fluid buildup.[1][2] These measures include HVPG, body weight, total body water, and changes in diuretic use, which are medicines that help the body remove extra fluid.[1][2]

In the kidney study, the main measure is eGFR over 24 months, because this helps show whether kidney function declines more slowly.[3] The study summary says the goal is to see whether the combination is superior to dapagliflozin alone in slowing kidney decline.[3]

Who the trials include

The study populations are adults with liver cirrhosis, adults with liver cirrhosis and portal hypertension, or adults with chronic kidney disease and high proteinuria.[1][2][3] The trial data do not give full eligibility rules, so exact entry criteria are not listed here.[1][2][3]

Trial design and comparators

All three studies are interventional trials, so they compare one treatment approach with another approach or with placebo.[1][2][3] In the liver studies, the trial data mention Zibotentan, dapagliflozin, placebo, and Zibotentan monotherapy in different groups.[1][2] In the kidney study, the comparison is between the Zibotentan plus dapagliflozin combination and dapagliflozin alone.[3]

Trial ID Phase Condition studied Status Enrollment Main outcome
2023-505405-17-00 Phase 2 Liver cirrhosis with portal hypertension Completed 217 Change in HVPG from baseline to Week 6
2023-506893-11-00 Phase 2 Cirrhosis of the liver Completed 66 Fluid retention and related body fluid measures to Week 6
NCT06087835 Phase 3 Chronic kidney disease and high proteinuria Authorised 1833 Change in eGFR from baseline to Month 24

FAQ

  • What conditions are being studied with Zibotentan? The trials study liver cirrhosis with portal hypertension and chronic kidney disease with high proteinuria. These are serious long-term conditions that can affect the liver or kidneys.
  • Who may take part in these trials? The trials include adults with liver cirrhosis or adults with chronic kidney disease and high proteinuria. Each study has its own rules for who can join.
  • What phases are the Zibotentan trials? The trial data include Phase 2, Phase 2b, and Phase 3 studies. Earlier phases often focus on short-term effects and safety, while Phase 3 usually looks at larger groups and longer-term benefit.
  • What are the trials trying to measure? In liver cirrhosis, one main measure is HVPG, which stands for hepatic venous pressure gradient and shows pressure in the liver blood vessels. In kidney disease, the main measure is eGFR, which shows how well the kidneys filter blood.
  • Is Zibotentan being studied alone or with another drug? Some studies test Zibotentan with dapagliflozin, and some compare the combination with placebo or with dapagliflozin alone. One cirrhosis study also looks at Zibotentan monotherapy, which means Zibotentan by itself.

Ongoing Clinical Trials on Zibotentan

  • Study on the Effects of Zibotentan and Dapagliflozin in Patients with Chronic Kidney Disease and High Protein Levels

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Austria Bulgaria Denmark France Germany Italy +6

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

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Germany Italy Poland Slovakia

  • Study on Zibotentan and Dapagliflozin for Patients with Liver Cirrhosis and Portal Hypertension

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +3

Glossary

  • Clinical trial: A research study in people that tests whether a treatment is safe and whether it helps with a disease.
  • Phase 2: A mid-stage trial that usually looks at early signs of benefit and safety in a smaller group of people.
  • Phase 2b: A later Phase 2 study that often gives more detail about how well a treatment works and how safe it is.
  • Phase 3: A larger trial that compares treatments in more people and helps show whether one treatment works better than another.
  • Portal hypertension: High blood pressure in the blood vessels that carry blood to the liver.
  • HVPG: Hepatic venous pressure gradient. This is a test result that helps measure pressure in the liver blood flow system.
  • Proteinuria: Too much protein in the urine. This can be a sign of kidney damage.
  • eGFR: Estimated glomerular filtration rate. This is a number that shows how well the kidneys are filtering blood.
  • Placebo: An inactive treatment used for comparison in a trial. It looks like the study drug but does not contain the active medicine.
  • Monotherapy: Treatment with one medicine only.
  • Fluid retention: When the body holds on to extra fluid, which can cause swelling or weight gain.

References

  1. https://clinicaltrials.gov/study/2023-505405-17-00
  2. https://clinicaltrials.gov/study/2023-506893-11-00
  3. https://clinicaltrials.eu/trial/study-on-the-effects-of-zibotentan-and-dapagliflozin-in-patients-with-chronic-kidney-disease-and-high-protein-levels/