A phase 2 clinical study to evaluate the efficacy, safety and tolerability of TransT3-60 vs placebo (a powder administered sublingually) in participants with Non-Alcoholic SteatoHepatitis (NASH)
- Conditions
- iver- Non-Alcoholic SteatoHepatitis (NASH)Liver- Non-Alcoholic SteatoHepatitis (NASH)Inflammatory and Immune System - Other inflammatory or immune system disordersOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12621001710819
- Lead Sponsor
- Invictus Ops Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
1. Age greater than 18 years.
2. Patients will be selected by investigators as likely to have NASH but not cirrhosis, based on the patient’s history, physical examination, imaging and laboratory tests or incidental recent liver biopsy.
3. MRI-PDFF hepatic fat fraction should be >8%.
4. Fibroscan score should indicate NASH and not cirrhosis.
5. Participant must read and understand the informed consent form and must have signed it prior to any study-related procedures being performed.
6. Willingness and ability to comply with all scheduled study visits and study procedures.
1. Chronic hepatitis B and C. Patients who are HCV PCR negative and have been negative for at least 12 months may be included. Patients with HBV on antiviral therapy with a HBV DNA <20 IU/mL for at least 6 months may be included.
2. HIV antibody positive.
3. Concomitant liver disease such as autoimmune hepatitis, primary biliary cirrhosis and Wilson’s disease.
4. Decompensated advanced liver disease and cirrhosis.
5. Treatment with medications known to cause fatty liver such as methotrexate, atypical neuroleptics and tamoxifen.
6. Uncontrolled hypo or hyperthyroidism.
7. Uncontrolled diabetes, HBA1c >9.
8. Active coronary artery disease defined as persisting angina.
9. Chronic kidney disease with an eGFR<60mL/min.
10. Platelet count<100,000/mm3, INR>1.3, ALT>5XULN.
11. Alcohol use >20g/day or substance abuse in the last 12 months.
12. Treatment with insulin sensitisers such as glitazones.
13. Treatment with silymarin (milk thistle).
14. Treatment with vitamin E (tocopherol) in the 4 weeks prior to study entry and for the duration of study participation.
15. Patients who are unable or unwilling to comply with the protocol requirements.
16. Women who are pregnant or lactating at the time of Randomisation.
17. Participation in any investigational study within 8 weeks of screening visit.
18. Participant has any other medical condition that, in the opinion of the investigator and/or medical monitor, would make the participant unsuitable for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method