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NTZ

Phase 2

Acute Decompensation of Liver Cirrhosis | Small molecule | Gastrointestinal |Genfit SA Sponsored ADR|Last Updated: Jul 9, 2026

Target and mechanism

ModalitySmall molecule

Also known as NTZ 500mg BID on top of SOC, NTZ on top of SOC

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

NTZ · 1 trial · 2 indications

Phase 2 1
NCT07694297Phase 2 Study of 500 mg BID NTZ on Top of Standard of Care in Patients With Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acute-on-Chronic Liver FailureAcute Decompensation of Liver Cirrhosis
NOT YET_RECRUITING16 Analytics
PHASE2NOT YET_RECRUITING
Phase 2 Study of 500 mg BID NTZ on Top of Standard of Care in Patients With Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acute-on-Chronic Liver Failure
Acute Decompensation of Liver Cirrhosis
NCT0769429716
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Study Endpoints

Primary Endpoints

To evaluate the safety of 500 mg BID NTZ administered perorally
over 7 days on top of SOC follow-up period up to Day 28.

Safety defined as the incidence, relatedness, and severity (NCI-CTCAE v6.0 grade) of TEAEs including SAEs (comprising the evaluation of vital signs, ECGs, and laboratory parameters).

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NTZ 500mg BID on top of SOCEXPERIMENTALTreatment period NTZ 500mg BID on top of SOC during 7 days.

Interventions

NameTypeDescription
NTZ 500mg BID on top of SOCDRUGTreatment period NTZ 500mg BID on top of SOC
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Eligibility Criteria

Age Range18 Years to 74 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Participants with liver cirrhosis of any underlying etiology (liver cirrhosis diagnosed by standard clinical criteria, imaging findings, and/or histology) * Recent acute clinica...

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Recent Changes (Last 90 Days)

LOWJul 9, 2026NCT07694297NEW_TRIAL: changed
LOWJul 9, 2026NCT07694297NEW_TRIAL: changed