Trials / Completed
CompletedNCT06269484
A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants With Cirrhosis-ZEAL-UNLOCK
A Multicentre, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Combination Compared to Zibotentan Monotherapy, Zibotentan/Dapagliflozin and Zibotentan Monotherapy Compared to Placebo in Participants With Cirrhosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase IIb multicentre, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the safety of zibotentan/dapagliflozin in combination as compared to zibotentan monotherapy as well as zibotentan/dapagliflozin and zibotentan monotherapy as compared to placebo in patients with cirrhosis.
Detailed description
The study is designed to evaluate the safety of zibotentan/dapagliflozin in combination as compared to zibotentan monotherapy as well as zibotentan/dapagliflozin in combination and zibotentan monotherapy as compared to placebo in patients with cirrhosis with or without a history of decompensation. The study will be conducted in approximately 52 study centers in North America, Asia and Europe.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo (placebo matching zibotentan capsule and placebo matching dapagliflozin tablet) | placebo capsule (matching zibotentan capsule) placebo tablet (matching dapagliflozin tablet) |
| DRUG | Zibotentan + placebo (placebo matching dapagliflozin tablet) | zibotentan capsule placebo tablet (matching dapagliflozin tablet) |
| DRUG | Zibotentan + dapagliflozin | zibotentan capsule dapagliflozin 10 mg tablet |
Timeline
- Start date
- 2024-02-15
- Primary completion
- 2024-12-11
- Completion
- 2024-12-11
- First posted
- 2024-02-21
- Last updated
- 2026-01-20
- Results posted
- 2026-01-20
Locations
34 sites across 10 countries: United States, Australia, Belgium, Czechia, Germany, Italy, Japan, Poland, Slovakia, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06269484. Inclusion in this directory is not an endorsement.