RO7790121 for Liver Fibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called RO7790121, an experimental drug, to determine its safety and effectiveness for individuals with liver fibrosis caused by metabolic dysfunction-associated steatohepatitis (MASH). Researchers aim to understand how the body processes the drug and its impact on liver health. Participants will receive the treatment initially through an IV and later through injections. The trial seeks individuals with significant fibrosis due to MASH and a body mass index between 25 and 45. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new drug.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot start new medications for diabetes, weight loss, cholesterol, or depression. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that RO7790121 is likely to be safe for humans?
Research shows that specific safety information for RO7790121 is not yet available. However, similar drugs used to treat fibrosis, such as pirfenidone, have been well-tolerated. While direct safety data for RO7790121 is lacking, drugs in the same group have generally proven safe. This trial is in an early stage, focusing primarily on the treatment's safety for participants. The treatment is still being tested to assess tolerability and potential side effects.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for liver fibrosis, which typically involve lifestyle changes and medications to manage symptoms, RO7790121 introduces an innovative approach by targeting specific pathways involved in the disease. This treatment is administered through an initial intravenous infusion followed by subcutaneous injections, potentially allowing for a more efficient delivery of the active ingredient directly to the affected areas. Researchers are particularly excited about RO7790121 because it could address the underlying causes of fibrosis rather than just alleviating symptoms, offering hope for more effective management of the condition.
What evidence suggests that RO7790121 might be an effective treatment for liver fibrosis?
Research has shown that RO7790121 targets TL1A, a protein involved in inflammation and tissue thickening and scarring. Studies have found that it can significantly reduce inflammation and intestinal scarring in patients with related conditions. In one study, different doses of RO7790121 led to clinical remission in about 23-25% of participants, compared to just 11.6% in those not receiving the treatment. These findings suggest that RO7790121, which participants in this trial will receive, could help reduce liver scarring in diseases like MASH (metabolic dysfunction-associated steatohepatitis). Although more research is needed, early results are promising for those with advanced tissue scarring.13678
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
This trial is for individuals with advanced MASH fibrosis, a type of liver scarring linked to metabolic dysfunction. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive RO7790121 via intravenous infusion followed by subcutaneous injections
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RO7790121
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University