A Study of a New Investigational Treatment Combination for NASH
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a study on Nonalcoholic Steatohepatitis Steatohepatitis Cirrhosis Liver Disease Nonalcoholic Fatty Liver Disease
Summary
- Eligibility
- for people ages 18-80 (full criteria)
- Location
- at Sacramento, California and other locations
- Dates
- study startedestimated completion
Description
Summary
The primary objective of this study is to evaluate whether the combination of semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR) causes fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with compensated cirrhosis due to NASH.
Official Title
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)
Keywords
Nonalcoholic Steatohepatitis, Fatty Liver, Non-alcoholic Fatty Liver Disease, Firsocostat, Semaglutide (SEMA), Cilofexor (CILO)/Firsocostat (FIR), PTM SEMA, PTM CILO/FIR, SEMA + CILO/FIR FDC, PTM SEMA + CILO/FIR FDC, PTM SEMA + PTM CILO/FIR
Eligibility
You can join if…
Open to people ages 18-80
- Liver biopsy consistent with cirrhosis (F4) due to NASH in the opinion of the central reader. In participants who have never had a liver biopsy, a screening liver biopsy may be performed
- 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
You CAN'T join if...
- 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 Gilbert's 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
- History of type 1 diabetes
- Treatment with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the period from 90 days prior to the screening visit and for individuals with a qualifying historical liver biopsy, for 90 days prior to the date of the historical liver biopsy
- For participants who have not completed a series of an authorized COVID-19 vaccination regimen prior to screening, a positive result for COVID-19 on SARS-CoV-2 RT-PCR test
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
- University of California, Davis Medical Center
accepting new patients
Sacramento California 95817 United States - Quest Clinical Research
accepting new patients
San Francisco California 94115 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Gilead Sciences
- Links
- Gilead Clinical Trials Website Sign up for this study
- ID
- NCT04971785
- Phase
- Phase 2 research study
- Study Type
- Interventional
- Participants
- Expecting 440 study participants
- Last Updated
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