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A Two Part Phase IIa/b Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Dose ranging Study to Assess 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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505405-17-00
Acronym
Zeal
Enrollment
111
Registered
2023-07-25
Start date
2022-10-07
Completion date
2025-07-17
Last updated
2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cirrhosis with features of portal hypertension.

Brief summary

Part A Primary End Point: Absolute change in HVPG from baseline to Week 6., Part B Primary End Point: Absolute change in HVPG from baseline to Week 6

Detailed description

Part A: Percent change in HVPG from baseline to Week 6., Part A: HVPG response, where a responder is defined as HVPG < 10 mmHg or a reduction in HVPG of ≥ 1.5 mmHg from baseline to Week 6., Part A: Evaluation of change in body weight (kg) over time course of study (Home-based balance) Percentage and absolute change from baseline in body weight at Week 6. (Office balance), Part A: Percentage and Absolute change in total change dosage of loopdiuretic equivalents use from baseline to Week 6., Part A: Change in total body water, extracellular water and intracellular water volumes from baseline to Week 6. Change in total body fat mass from baseline to Week 6., Part A: Change in systolic and diastolic blood pressure from baseline to Week 6, Part B: Percentage and change in HVPG from baseline to Week 6., Part B: Evaluation of change in body weight (kg) over time course of study. (Home-based balance) Percentage and absolute change from baseline in body weight at Week 6 and Week 16. (Office balance), Part B: Absolute change in total dosage of loop-diuretic equivalents use from baseline to Week 6 and Week 16, Part B: Change in total body water, extracellular water and intracellular water volumes from baseline to Week 6 and Week 16. Change in total body fat mass from baseline to Week 6 and Week 16, Part B: Change in systolic and diastolic blood pressure from baseline to Week 6 and Week 16., Part B : To evaluate Part B: HVPG response, where a responder is defined as at least 20% decrease or a reduction to or below 12 mmHg in HVPG from baseline to Week 6.

Interventions

Sponsors

Astrazeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part A Primary End Point: Absolute change in HVPG from baseline to Week 6., Part B Primary End Point: Absolute change in HVPG from baseline to Week 6

Secondary

MeasureTime frame
Part A: Percent change in HVPG from baseline to Week 6., Part A: HVPG response, where a responder is defined as HVPG < 10 mmHg or a reduction in HVPG of ≥ 1.5 mmHg from baseline to Week 6., Part A: Evaluation of change in body weight (kg) over time course of study (Home-based balance) Percentage and absolute change from baseline in body weight at Week 6. (Office balance), Part A: Percentage and Absolute change in total change dosage of loopdiuretic equivalents use from baseline to Week 6., Part A: Change in total body water, extracellular water and intracellular water volumes from baseline to Week 6. Change in total body fat mass from baseline to Week 6., Part A: Change in systolic and diastolic blood pressure from baseline to Week 6, Part B: Percentage and change in HVPG from baseline to Week 6., Part B: Evaluation of change in body weight (kg) over time course of study. (Home-based balance) Percentage and absolute change from baseline in body weight at Week 6 and Week 16. (Office b

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Netherlands, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026