RO7790121 for Liver Fibrosis

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Hoffmann-La Roche

No Placebo Group

Trial Summary

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.

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Treatment Details

Interventions

RO7790121 (Monoclonal Antibodies)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: RO7790121Experimental Treatment1 Intervention

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