RecruitingPhase 2ACTRN12621001710819

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)

A Randomised, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Sublingual TransT3-60 in the Treatment of Non-Alcoholic SteatoHepatitis (NASH)

Sponsor

Invictus Ops Pty Ltd

Enrollment

80 participants

Start Date

Jul 5, 2022

Study Type

Interventional

Conditions

Liver- Non-Alcoholic SteatoHepatitis (NASH)

Summary

Non-alcoholic steatohepatitis (NASH) is an advanced form of non-alcoholic fatty liver disease (NAFLD). NAFLD is caused by a build-up of fat in the liver. This build-up causes inflammation and damage, known as NASH, leading to scarring of the liver and developing the life-threatening condition of cirrhosis. There are no medicines currently approved for the treatment of NASH. Current treatments include dietary changes, weight loss, increased exercise and treatment of associated dyslipidaemia and metabolic syndrome. Recent studies suggest that lifestyle changes (nutritional counselling and exercise) with or without 100mg per day of a mixed tocotrienol product for 3 months showed a decrease in liver stiffness. 79% of those who improved were from the tocotrienol group and 21% from the lifestyle only group. This study will compare treatment with the tocotrienol, TransT3-60, a sublingual powder, to matching placebo, to compare the effects on liver structure measured by ultrasound and magnetic resonance imaging. Safety assessments will be conducted at baseline and 4 weekly intervals. A total of 80 participants will be randomly allocated (1:1) to either the tocotrienol treatment (TransT3-60) or to the placebo group for 24 weeks.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Non-alcoholic steatohepatitis (NASH) is a serious form of fatty liver disease where fat build-up causes liver inflammation and scarring. Left untreated, it can progress to cirrhosis (severe liver scarring) or liver failure. Currently, there are no approved medications for NASH — management relies on lifestyle changes. This study tests whether a tocotrienol supplement (a natural form of vitamin E found in palm oil) called TransT3-60, delivered as a sublingual (under-the-tongue) powder, can reduce liver fat and inflammation. Participants will be randomly assigned to receive either TransT3-60 or a placebo for 24 weeks. The effects on the liver will be measured using ultrasound and MRI scans at regular intervals. Blood tests will also be performed to monitor safety throughout the study. You may be eligible if you are 18 years or older and are likely to have NASH based on imaging, laboratory results, or a recent liver biopsy — but do not have cirrhosis. People with active viral hepatitis, HIV, other liver diseases, uncontrolled diabetes, advanced kidney disease, active heart disease, or who are pregnant would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

60mg tocotrienol (TransT3-60) powder, self-administered sublingually three times daily for 24 weeks. Supervised administration: The participant will self-administer their first dose on site under t

60mg tocotrienol (TransT3-60) powder, self-administered sublingually three times daily for 24 weeks. Supervised administration: The participant will self-administer their first dose on site under the supervision of a qualified study staff member during their first dosing appointment. Prior to this first dose, participants will be instructed on how to self-administer the powder. This process includes the staff member going through an instruction sheet on how to self-administer the powder, a copy of which will be provided to the participant to take home. The staff member will provide the opportunity for the participant to ask any questions about the administration process if they are unsure. After the first dose, a self-report diary will be provided to the participant to record all subsequent dosing details, as well as any adverse reactions and concomitant medications they may have while on study. The staff member will instruct the participant on how to fill out the diary, and the participant will be able to ask any questions if needed. The diary will include contact details in the event the participant has any questions about self-administration while at home. Study staff will also confirm during subsequent clinic visits that the participant is adhering to the administration requirements.

Locations(1)

NSW,QLD,SA,WA,VIC, Australia

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ACTRN12621001710819