Assessing a new treatment for advanced liver fibrosis caused by MASH
A Phase Ib, Multicenter, Open-Label, Single-Arm Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Patients With Advanced MASH Liver Fibrosis
This study is testing a new drug called RO7790121 to see if it can improve liver health in people with advanced liver fibrosis caused by MASH.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Locations | 14 sites (Tucson, Arizona and 13 other locations) |
| Trial ID | NCT06903065 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, pharmacokinetics, and activity of a new drug called RO7790121 in participants suffering from advanced metabolic dysfunction-associated steatohepatitis (MASH) fibrosis. Participants will be monitored for their response to the treatment, including any side effects and how the drug is processed in the body. The study aims to determine the effectiveness of RO7790121 in improving liver health in individuals with significant fibrosis. It is a Phase 1 interventional trial, focusing on a specific patient population with advanced liver conditions.
Who should consider this trial
Good fit: Ideal candidates are adults with a body mass index between 25 and 45 kg/m² and confirmed advanced MASH fibrosis.
Not a fit: Patients with significant weight fluctuations, decompensated liver disease, or other serious liver conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced liver fibrosis due to MASH.
How similar studies have performed: While this approach is novel, similar studies targeting liver fibrosis have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body mass index within the range of \>= 25 and \<=45 kilograms per square meter (kg/m\^2) * MASH with fibrosis score of F3 or F4 confirmed by transient elastography measurement \>=12.0 kPa and \<=25.0 kPa * Agreement to adhere to the contraception requirements Exclusion Criteria: * Weight gain or loss \>5% in the 3 months prior to baseline or \>10% in the 6 months prior to baseline * Bariatric surgery within 1 year prior to baseline * Current signs or prior history of decompensated liver disease * Complications or clinical evidence of portal hypertension * Lack of peripheral venous access * Other causes of liver disease based on medical history and/or centralized review of liver histology * History of liver transplantation * Current or prior history of hepatocellular carcinoma (HCC) * Uncontrolled hypertension * Concomitant Type 1 diabetes, or Type 2 diabetes with HbA1c \>10% * History of malignancy within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death * Current, significant alcohol consumption or a history of significant alcohol consumption for a period of more than 3 consecutive months any time within 1 year prior to screening * Initiation of a medication of an antidiabetic, weight loss, lipid-modifying or anti-depressant drug class * Active tuberculosis requiring treatment within the 12 months prior to baseline * History of organ transplant
Where this trial is running
Tucson, Arizona and 13 other locations
- Adobe Clinical Research, LLC — Tucson, Arizona, United States (Recruiting)
- Gastrointestinal Specialists of Georgia, PC — Marietta, Georgia, United States (Recruiting)
- Delta Research Partners, LLC (Bastrop) — Bastrop, Louisiana, United States (Recruiting)
- Jubilee Clinical Research, Inc — Las Vegas, Nevada, United States (Recruiting)
- Premier Medical Group Int Medcn — Clarksville, Tennessee, United States (Recruiting)
- Pinnacle Clinical Research - Austin — Austin, Texas, United States (Recruiting)
- Bellaire Clinical Research, LLC — Bellaire, Texas, United States (Recruiting)
- DHR Health Institute for Research and Development — Edinburg, Texas, United States (Recruiting)
- Pinnacle Clinical Research Georgetown — Georgetown, Texas, United States (Recruiting)
- Houston Research Institute — Houston, Texas, United States (Recruiting)
- Pinnacle Clinical Research, PLLC — San Antonio, Texas, United States (Recruiting)
- GI Alliance — Southlake, Texas, United States (Recruiting)
- FDI Clinicial Research - Mayaguez — Mayagez, Puerto Rico (Recruiting)
- Fundacion de Investigacion de Diego — San Juan, Puerto Rico (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: CC45687 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.