Trial · NCT05516498
Zibotentan and Dapagliflozin Combination, EvAluated in Liver Cirrhosis (ZEAL Study)
NCT05516498, Phase 2, Terminated, AstraZeneca
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Zibotentan and Dapagliflozin Combination, EvAluated in Liver Cirrhosis (ZEAL Study). Trials, record NCT05516498. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05516498
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Zibotentan and Dapagliflozin Combination, EvAluated in Liver Cirrhosis (ZEAL Study)
- NCT number
- NCT05516498
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 205 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Liver Cirrhosis
- Interventions
Part A: Placebo (matching zibotentan capsule & matching dapagliflozin tablet), Part A: zibotentan (dose B) + dapagliflozin, Part B: Placebo (matching zibotentan capsule & matching dapagliflozin tablet), Part B: placebo (matching zibotentan capsule) + dapagliflozin, Part B: zibotentan (dose A) + dapagliflozin, Part B: zibotentan (dose B) + dapagliflozin, Part B: zibotentan (dose C) + dapagliflozin
- First posted
- 2022-08-25
- Last updated
- 2026-09-25
- Other registries' IDs
- eudract:2021-006577-30
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change in HVPG From Baseline to Week 6, Part A | From Baseline to Week 6 | Absolute change in Hepatic venous pressure gradient from baseline to week 6. |
| Primary | Absolute Change in HVPG From Baseline to Week 6, Part B | From Baseline to Week 6 | Absolute change in Hepatic venous pressure gradient from baseline to week 6. |
| Secondary | HVPG Percentage Change From Baseline to Week 6, Part A | From Baseline to Week 6 | Hepatic venous pressure gradient percentage change from baseline to week 6, Part A. |
| Secondary | HVPG Percentage Change From Baseline to Week 6, Part B | From baseline to week 6 | Hepatic venous pressure gradient percentage change from baseline to week 6, Part B. |
| Secondary | Number of Participants With HVPG Response at Week 6, Part A | From baseline to week 6 | A HVPG responder is defined as a subject having \<10 mmHg at week 6 if baseline HVPG \>=10 or a reduction of \>=1.5 mmHg from baseline to week 6. n: Number of subjects in analysis. N: Number of subjects per treatment group. |
| Secondary | Number of Participants With HVPG Response at Week 6, Part B | From baseline to Week 6 | A HVPG responder in Part B is defined as a subject having at least 20% decrease or a reduction to or below 12 mmHg if baseline HVPG \> 12 mmHG from baseline to Week 6. |
| Secondary | Change in Body Weight (kg) Over Time Course of Study, Part A | From baseline to Week 6 | The analysis is performed using MMRM. The model includes the continuous covariate of the Baseline measurements as the fixed effect covariate and fixed categorical effects of treatment group, visit, and treatmentby-visit interaction. |
| Secondary | Change in Body Weight (kg) Over Time Course of Study, Part B | From baseline to Week 6 and Week 16 | The analysis is performed using MMRM. The model includes the continuous covariate of the Baseline measurements as the fixed effect covariate and fixed categorical effects of treatment group, visit, and treatmentby-visit interaction. |
| Secondary | Change in Total Dosage of Loop-diuretic Equivalents Use From Baseline to Week 6, Part A | From baseline to Week 6 | Change in total dosage of loop-diuretic equivalents use from baseline to Week 6, Part A. A loop-diuretic equivalent is based on 40 mg furosemide = 1 mg bumetanide = 20 mg torsemide = 50 mg ethacrynic acid. |
| Secondary | Change in Total Dosage of Loop-diuretic Equivalents Use From Baseline to Week 6 and Week 16, Part B | From Baseline to Week 6 and Week 16 | Change in total dosage of loop-diuretic equivalents use from baseline to Week 6, Part B. A loop-diuretic equivalent is based on 40 mg furosemide = 1 mg bumetanide = 20 mg torsemide = 50 mg ethacrynic acid. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05516498
GET https://conductscience.org/api/trials/v1/NCT05516498/registered?page=2