About the Study
Fat buildup in the liver can lead to serious health issues, including inflammation and scarring. Researchers are studying a potential treatment for metabolic dysfunction-associated steatohepatitis (MASH) to help protect liver health.
Participants will receive health assessments, imaging scans, and study medication at no cost. Take the next step—sign up today to learn more and see if you qualify!
Why Participate?
- Participants will receive a new potential treatment for MASH at no cost.
- Participants will be compensated per clinic visit.
- Participants may experience improvements in weight reduction.
- Participants will be contributing valuable information that may
- benefit those with MASH in the future.
- Participants will be helping to advance medical research.
Your Rights
- You will receive a detailed outline of all details of the study, including treatment, risks, and procedures, and you will be given the chance to ask study staff questions before you decide whether to participate.
- If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time
- Your records relating to this study and any other information received will be kept strictly confidential, except as required by the law.
Who Can Participate?
- Must be willing to use effective contraception throughout the study.
- Must not be pregnant, breastfeeding, or planning to become pregnant (if female).
- Must not have type 1 diabetes.
- Must not have a history of severe allergic reactions to GLP-1 receptor agonists (e.g., Ozempic, Trulicity, and Saxenda).
- Must not have used GLP-1 receptor agonists within the past 90 days.
- Must not be taking certain medications (e.g., high-dose vitamin E, pioglitazone, amiodarone, methotrexate, steroids, tamoxifen, anabolic steroids, valproic acid).
- Must not have claustrophobia or metal implants that would prevent an MRI from being performed.
- Must be willing to follow study requirements, including fasting before tests, avoiding caffeine/nicotine, and attending all study visits.
- Must be able to visit the research centre 40 times and complete study procedures over a 34-week period.
More Study Details
The study team will explain the research in its entirety but some details are:
- The study lasts up to 34 weeks and includes a screening period, treatment phases (including dose adjustments and follow-ups), and a final visit.
- Participants will complete informed consent and have check-ups like physical exams, medical history, weight and blood pressure checks, ECGs, and lab tests (fasting and non-fasting blood samples, urine, and pregnancy tests).
- Imaging may include scans like FibroScan®, MRI-PDFF, and MRE (all done while fasting). Participants will also have their health and medications reviewed by the study team.
This study has been reviewed and approved by the Bellberry Human Research Ethics Committee.
About the Research Sites
TrialsWest Perth
Locations:
- Spearwood Site: 6 Barrington Street, Spearwood, WA 6163
Lead Researcher: Professor John Olynyk - Osborne Park Site: 226 Main Street, Osborne Park, WA 6017
Lead Researcher: Professor John Olynyk
Captain Stirling Medical Centre
Location: 92 Stirling Hwy, Nedlands WA 6009
Lead Researcher: Dr. Michael Benson