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NCT05516498 · ClinicalTrials.gov registry record · Phase 2
Zibotentan and Dapagliflozin Combination, EvAluated in Liver Cirrhosis (ZEAL Study)
A Phase 2 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 2
- Development phase
- 205
- Enrollment target
NCT05516498 is a Phase 2 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 205 participants.
The verdict
NCT05516498, a Phase 2 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 205 participants
- Enrollment target
Study Summary
This is a two part Phase IIa/b multicentre, randomised, double-blind, placebo-controlled, parallel group dose-ranging study to assess the efficacy, safety, and tolerability of the combination of zibotentan and dapagliflozin, and dapagliflozin monotherapy versus placebo in participants with cirrhosis with features of portal hypertension.
Interventions
- DRUG Part A: Placebo (matching zibotentan capsule & matching dapagliflozin tablet)
- DRUG Part A: zibotentan (dose B) + dapagliflozin
- DRUG Part B: Placebo (matching zibotentan capsule & matching dapagliflozin tablet)
- DRUG Part B: placebo (matching zibotentan capsule) + dapagliflozin
- DRUG Part B: zibotentan (dose A) + dapagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2022-10-31 |
| Est. Completion | 2025-07-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05516498
The ClinicalTrials.gov registry entry for NCT05516498 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 205 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Part A: Placebo (matching zibotentan capsule & matching dapagliflozin tablet) is the first listed.
NCT05516498 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05516498 about?
NCT05516498 is a clinical study titled "Zibotentan and Dapagliflozin Combination, EvAluated in Liver Cirrhosis (ZEAL Study)". This is a two part Phase IIa/b multicentre, randomised, double-blind, placebo-controlled, parallel group dose-ranging study to assess the efficacy, safety, and tolerability of the combination of zibotentan and dapagliflozin, and dapagliflozin monotherapy versus placebo in participants with cirrhosis...
What is the current status of trial NCT05516498?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 205 participants. The study started on 2022-10-31. Estimated completion is 2025-07-17.
What interventions are being tested in trial NCT05516498?
The interventions under investigation include: Part A: Placebo (matching zibotentan capsule & matching dapagliflozin tablet) (DRUG), Part A: zibotentan (dose B) + dapagliflozin (DRUG), Part B: Placebo (matching zibotentan capsule & matching dapagliflozin tablet) (DRUG), Part B: placebo (matching zibotentan capsule) + dapagliflozin (DRUG), Part B: zibotentan (dose A) + dapagliflozin (DRUG).
Who is sponsoring clinical trial NCT05516498?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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