Trial · NCT06269484

A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants With Cirrhosis-ZEAL-UNLOCK

NCT06269484, Phase 2, Completed, AstraZeneca; results first posted 2026-01-20

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants With Cirrhosis-ZEAL-UNLOCK. Trials, record NCT06269484. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06269484

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants With Cirrhosis-ZEAL-UNLOCK
NCT number: NCT06269484
Status: Completed
Phases: Phase 2
Enrollment: 73 participants, actual
Lead sponsor: AstraZeneca
Conditions: Liver Cirrhosis
Interventions: Placebo (placebo matching zibotentan capsule and placebo matching dapagliflozin tablet), Zibotentan + placebo (placebo matching dapagliflozin tablet), Zibotentan + dapagliflozin
First posted: 2024-02-21
Last updated: 2026-01-20
Results first posted: 2026-01-20

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cumulative Number of Subjects With Any of the Components of the Composite Endpoint: >2kg Increase in Body Weight (Office-based), >2 L Increase in Total Body Water, Increase in 2 or More Loop-diuretic Equivalents, Fluid Retention Adverse Event (AE)	baseline to Week 6	Cumulative number of subjects with event of composite fluid retention endpoint
Secondary	Change From Baseline in Body Weight	at Week 6	Change in site body weight
Secondary	Change From Baseline in Body Fat Mass	at Week 6
Secondary	Change From Baseline in Total Body Water	at Week 6
Secondary	Change From Baseline in Extracellular Water Volume	at Week 6
Secondary	Change From Baseline in Intracellular Water Volume	at Week 6
Secondary	Change in Body Weight (kg) Over Time Course of Study	at Week 6	Change in home body weight
Secondary	Change in Total Dosage of Loop-diuretic Equivalents Use	at Week 6	One loop-diuretic equivalent = 40 mg furosemide = 1 mg bumetanide = 20 mg torsemide = 50 mg ethacrynic acid. In Japan, one loop-diuretic equivalent = 40 mg furosemide = 8 mg torsemide = 60 mg azosemide.
Secondary	Cumulative Number of Subjects With Either of the Two Components of This Composite: 1. >3 L Increase in Total Body Water Volume From Baseline to Week 6 2. Increase in 3 or More Loop-diuretics Equivalents Use	from baseline to Week 6	Cumulative number of subjects with event of composite and the components of total body water and total dosage of loop-diuretic equivalents
Secondary	Absolute Change in Systolic Blood Pressure	at Week 6

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cumulative Number of Subjects With Any of the Components of the Composite Endpoint: >2kg Increase in Body Weight (Office-based), >2 L Increase in Total Body Water, Increase in 2 or More Loop-diuretic Equivalents, Fluid Retention Adverse Event (AE)	baseline to Week 6	All randomised subjects who received at least one dose of treatment are included in the analysis.~For intercurrent events treatment policy strategy was used. No imputation was performed.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Body Weight	at Week 6	All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.	kg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Body Fat Mass	at Week 6	All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.	kg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Total Body Water	at Week 6	All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.	L	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Extracellular Water Volume	at Week 6	All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.	L	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Intracellular Water Volume	at Week 6	All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.	L	LEAST_SQUARES_MEAN
SECONDARY	Change in Body Weight (kg) Over Time Course of Study	at Week 6	All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.	kg	LEAST_SQUARES_MEAN
SECONDARY	Change in Total Dosage of Loop-diuretic Equivalents Use	at Week 6	All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.	Loop-diuretic mg equivalent	LEAST_SQUARES_MEAN
SECONDARY	Cumulative Number of Subjects With Either of the Two Components of This Composite: 1. >3 L Increase in Total Body Water Volume From Baseline to Week 6 2. Increase in 3 or More Loop-diuretics Equivalents Use	from baseline to Week 6	All randomised subjects who received at least one dose of treatment are included in the analysis.~For intercurrent events treatment policy strategy was used. No imputation was performed.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Absolute Change in Systolic Blood Pressure	at Week 6	All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.	mmHg	LEAST_SQUARES_MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group33

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Cumulative Number of Subjects With Any of the Components of the Composite Endpoint: >2kg Increase in Body Weight (Office-based), >2 L Increase in Total Body Water, Increase in 2 or More Loop-diuretic Equivalents, Fluid Retention Adverse Event (AE)	Zibo/Dapa	14		Participants
Cumulative Number of Subjects With Any of the Components of the Composite Endpoint: >2kg Increase in Body Weight (Office-based), >2 L Increase in Total Body Water, Increase in 2 or More Loop-diuretic Equivalents, Fluid Retention Adverse Event (AE)	Zibo	14		Participants
Cumulative Number of Subjects With Any of the Components of the Composite Endpoint: >2kg Increase in Body Weight (Office-based), >2 L Increase in Total Body Water, Increase in 2 or More Loop-diuretic Equivalents, Fluid Retention Adverse Event (AE)	Placebo	6		Participants
Change From Baseline in Body Weight	Zibo/Dapa	-1.08	90% Confidence Interval -1.88 to -0.28	kg
Change From Baseline in Body Weight	Zibo	0.64	90% Confidence Interval -0.11 to 1.39	kg
Change From Baseline in Body Weight	Placebo	-0.53	90% Confidence Interval -1.31 to 0.24	kg
Change From Baseline in Body Fat Mass	Zibo/Dapa	-1.68	90% Confidence Interval -2.43 to -0.94	kg
Change From Baseline in Body Fat Mass	Zibo	-0.23	90% Confidence Interval -0.93 to 0.48	kg
Change From Baseline in Body Fat Mass	Placebo	-0.30	90% Confidence Interval -1.03 to 0.42	kg
Change From Baseline in Total Body Water	Zibo/Dapa	0.36	90% Confidence Interval -0.22 to 0.94	L

1 to 10 of 33Source ClinicalTrials.gov

See all 33 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Zibo/Dapa	24
Overall Study	STARTED	Zibo	25
Overall Study	STARTED	Placebo	24
Overall Study	TREATED	Zibo/Dapa	24
Overall Study	TREATED	Zibo	24
Overall Study	TREATED	Placebo	24
Overall Study	COMPLETED	Zibo/Dapa	20
Overall Study	COMPLETED	Zibo	24
Overall Study	COMPLETED	Placebo	22
Overall Study	NOT COMPLETED	Zibo/Dapa	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events39

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Thrombocytopenia	Blood and lymphatic system disorders	Zibo/Dapa	2	24	2
other	Thrombocytopenia	Blood and lymphatic system disorders	Zibo	0	24	0
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	0	24	0
other	Fluid retention	Metabolism and nutrition disorders	Zibo/Dapa	3	24	3
other	Fluid retention	Metabolism and nutrition disorders	Zibo	1	24	1
other	Fluid retention	Metabolism and nutrition disorders	Placebo	0	24	0
other	Headache	Nervous system disorders	Zibo/Dapa	5	24	5
other	Headache	Nervous system disorders	Zibo	6	24	7
other	Headache	Nervous system disorders	Placebo	1	24	1
other	Orthostatic hypotension	Vascular disorders	Zibo/Dapa	3	24	5

1 to 10 of 39Source ClinicalTrials.gov

See all 39 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Zibo/Dapa	0	24
Total, all-cause mortality	Zibo	0	24
Total, all-cause mortality	Placebo	0	24
Total, other adverse events	Zibo/Dapa	14	24
Total, other adverse events	Zibo	15	24
Total, other adverse events	Placebo	4	24
Total, serious adverse events	Zibo/Dapa	1	24
Total, serious adverse events	Zibo	2	24
Total, serious adverse events	Placebo	1	24

Source ClinicalTrials.gov

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/NCT06269484

GET https://conductscience.org/api/trials/v1/NCT06269484/results?page=2

API reference For AI assistants