Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Nonalcoholic Steatohepatitis (nash),covid-19
• Age: Between 18 years - 80 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Willing and able to give informed consent prior to any study-specific procedures being performed.
  2. Cirrhosis (F4) due to NASH.
  3. BMI = 23 kg/m2 at screening.

  
  

You may not be eligible for this study if the following are true:

• 1. Chronic HBV infection (HBsAg positive).
  2. Chronic HCV infection (HCV antibody and HCV RNA positive).
  3. Other causes of liver disease based on medical history and/or central pathologist review of liver histology, including but not limited to: alcoholic liver disease, autoimmune disorders (eg, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency.
  4. History of liver transplantation.
  5. Current or prior history of hepatocellular carcinoma (HCC).
  6. HIV infection.
  7. Any weight reduction surgery or procedure in the 2 years prior to screening or malabsorptive weight loss surgery (eg, Roux-en-Y or distal gastric bypass) at any time prior to screening.
  8. Weight loss >10% within 180 days of screening, or >5% between the date of the biopsy used for eligibility and the date of screening.
  9. History of intestinal resection that could result in malabsorption of study drug.
  10. Planned coronary, carotid, or peripheral artery intervention or unstable cardiovascular disease.
  11. 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).
  12. Positive urine drug screen for amphetamines, cocaine, or opiates (eg, heroin, morphine) at screening, unless due to a prescription medication.
  13. Participation in another investigational study of a drug or device within 30 days or within 5 half-lives of the prior investigational agent (whichever is longer) prior to the date of screening and through the end of the study.
  14. History of malignancy within 5 years of screening.
  15. Acute pancreatitis within 180 days prior to screening.
  16. History or presence of chronic pancreatitis.
  17. History of symptomatic gallbladder or biliary tract disease in the opinion of the investigator within 6 months prior to screening, unless a cholecystectomy has been performed.
  18. Presence or history of type 1 diabetes.
  19. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullar thyroid carcinoma.
  20. Female who is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not using an adequate contraceptive method.
  21. Men who engage in heterosexual intercourse not using an adequate method of contraception.
  22. Known hypersensitivity to the study drug(s), metabolites, or formulation excipient(s).
  23. For patients 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.