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Clinical Trials/JPRN-jRCT2071210112
JPRN-jRCT2071210112
Active, not recruiting
Phase 2

A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects With Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

Kamiya Makoto0 sites440 target enrollmentJanuary 19, 2022
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Conditionsonalcoholic Steatohepatitis

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
onalcoholic Steatohepatitis
Sponsor
Kamiya Makoto
Enrollment
440
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 19, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Kamiya Makoto

Eligibility Criteria

Inclusion Criteria

  • •Liver biopsy consistent with cirrhosis (F4\) due to NASH in the opinion of the central reader.
  • •\- Screening laboratory parameters as determined by the study central laboratory:
  • •\- Estimated glomerular filtration rate (eGFR) \>\= 30 mL/min/1\.73m2, as calculated by the Modification of Diet in Renal Disease (MDRD)equation
  • •\- HbA1c \<\= 10%
  • •\- INR \<\= 1\.4, unless due to therapeutic anticoagulation
  • •\- Platelet count\>\= 125,000/uL
  • •\- Alanine Aminotransferase (ALT) \< 5 x ULN
  • •\- Serum albumin \>\= 3\.5 g/dL
  • •\- Serum Alkaline Phosphatase (ALP) \<\= 2 x ULN
  • •\- BMI \>\= 23 kg/ m2 at screening

Exclusion Criteria

  • •\- Prior history of decompensated liver disease, including ascites, hepatic encephalopathy (HE), or variceal bleeding
  • •\- Child\-Pugh (CP) score \> 6 at screening, unless due to an alternative etiology such as Gilberts syndrome or therapeutic anticoagulation
  • •\- Model for End\-stage Liver Disease (MELD) score \> 12 at screening, unless due to an alternative etiology such as therapeutic anticoagulation
  • •\- Other causes of liver disease based on medical history and/or central reader review of liver histology, including but not limited to: alcoholic liver disease, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug\-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha\-1\-antitrypsin deficiency
  • •\- Chronic HBV infection (HBsAg positive), or Chronic HCV infection (HCV antibody and HCV RNA positive). Participants cured of HCV infection less than 2 years prior to the screening visit are not eligible
  • •\- History of liver transplantation
  • •\- Current or prior history of hepatocellular carcinoma (HCC)
  • •\- Men who habitually drink greater than 21 units/week of alcohol or women who habitually drink greater than 14 units/week of alcohol (one unit is equivalent to 12 oz/360 mL of beer, a 4 oz/120 mL glass of wine, or 1 oz/30 mL of hard liquor).
  • •\- For individuals on vitamin E regimen \>\= 800 IU/day, or pioglitazone, dose must be stable, in the opinion of the investigator for at least 180 days prior to the historical or screening liver biopsy
  • •\- For individuals on medications for diabetes, dose must be stable, in the opinion of the investigator, for at least 90 days prior to the historical or screening liver biopsy

Outcomes

Primary Outcomes

Not specified

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