RO7790121 for Liver Fibrosis

Recruiting at 13 trial locations

Overseen By Reference Study ID Number: CC45687 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hoffmann-La Roche

Must not be taking: Antidiabetics, Weight loss, Lipid-modifying, Antidepressants

Disqualifiers: Decompensated liver disease, Portal hypertension, Diabetes, Alcohol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

50 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug RO7790121 for liver fibrosis?

Research on the antifibrotic drug pirfenidone, which is used for lung fibrosis, shows improvements in liver conditions similar to liver fibrosis, suggesting potential benefits for liver fibrosis treatment. Additionally, studies on other antifibrotic drugs highlight shared treatment targets in liver diseases, indicating possible effectiveness of RO7790121. ^{1 2 3 4 5}

Is RO7790121 safe for humans?

There is no specific safety data available for RO7790121, but similar antifibrotic drugs like pirfenidone have been shown to be generally safe and well-tolerated in treating idiopathic pulmonary fibrosis, with some manageable side effects. ^{1 2 6 7 8}

What is the purpose of this trial?

The purpose of this study is to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and activity of RO7790121 in participants with advanced metabolic dysfunction-associated steatohepatitis (MASH) fibrosis.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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

Body mass index within the range of >= 25 and <= 45 kilograms per square meter (kg/m^2)

My liver is severely scarred, confirmed by a specific test.

Agreement to adhere to the contraception requirements

Exclusion Criteria

Concomitant Type 1 diabetes, or Type 2 diabetes with HbA1c > 10%

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

I have started taking medication for diabetes, weight loss, cholesterol, or depression.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RO7790121 via intravenous infusion followed by subcutaneous injections

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RO7790121

Trial Overview The study is testing RO7790121 in patients with advanced MASH fibrosis. It aims to evaluate the safety of the drug, how it's processed by the body (pharmacokinetics), its effects on the disease (pharmacodynamics), whether it triggers immune responses (immunogenicity), and its overall effectiveness.

Participant Groups

Group I: RO7790121 Experimental Treatment 1 Intervention

Particiapants will receive RO7790121 via intravenous (IV) infusion followed by subcutaneous (SC) injections.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

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

Findings from Research

In a study of 281 patients with advanced liver fibrosis, those treated with prolonged-release pirfenidone (PR-PFD) showed a significant reduction in fibrosis (35%) compared to only 4.1% in patients receiving standard care, indicating its efficacy in treating this condition.

PR-PFD treatment also led to improvements in quality of life scores and was generally safe, with only 12% of patients reporting mild side effects like transient burning or nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of prolonged-release pirfenidone plus standard of care treatment in patients with advanced liver fibrosis: PROMETEO study. Poo, JL., Torre, A., Aguilar-Ramírez, JR., et al.[2021]

In a study of 281 patients with idiopathic pulmonary fibrosis (IPF) treated with either pirfenidone or nintedanib, both drugs were found to be safe and well-tolerated, confirming their safety profiles in real-world settings.

Nintedanib was associated with a lower rate of permanent treatment discontinuation (8.3%) compared to pirfenidone (18.3%), and adverse events from nintedanib were generally easier to manage, indicating it may be a more favorable option for long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience. Levra, S., Guida, G., Sprio, AE., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Repurposing Pirfenidone for Nonalcoholic Steatohepatitis-related Cirrhosis: A Case Series. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Strategies and endpoints of antifibrotic drug trials: Summary and recommendations from the AASLD Emerging Trends Conference, Chicago, June 2014. [2018]

3. England pubmed.ncbi.nlm.nih.gov

New and emerging anti-fibrotic therapeutics entering or already in clinical trials in chronic liver diseases. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

TAF and TDF attenuate liver fibrosis through NS5ATP9, TGFβ1/Smad3, and NF-κB/NLRP3 inflammasome signaling pathways. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Benefits of prolonged-release pirfenidone plus standard of care treatment in patients with advanced liver fibrosis: PROMETEO study. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Current investigations for liver fibrosis treatment: between repurposing the FDA-approved drugs and the other emerging approaches. [2023]

7. England pubmed.ncbi.nlm.nih.gov

An update on the recent advances in antifibrotic therapy. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience. [2022]