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

NCT06269484 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2026-01-20

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2024-12-11
Completion
2024-12-11
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Czechia
  • Germany
  • Italy
  • Japan
  • Poland
  • Slovakia
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06269484 on ClinicalTrials.gov