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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Participants will be administered RO7790121 via IV infusion on Day 1, and Weeks 2, 6 and 10. Participants will then be administered RO7790121 SC injections every four weeks (Q4W) from week 14 up to and including Week 50.
Adobe Clinical Research, LLC
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to Week 52 after Baseline
Change from Baseline in Liver Stiffness
Liver stiffness will be measured by transient elastography (FibroScan® or FibroTouch®) and indicated in kilopascals (kPa).
Time frame: Baseline to Week 52
Change from Baseline in Serum Levels of Propeptide of Type lll Collagen (Pro-C3)
Time frame: Baseline to Week 52
Change from Baseline in Serum Enhanced Liver Fibrosis (ELF) Test
Time frame: Baseline to Week 52
Change from Baseline in Fibro-inflammation
Fibro-inflammation will be measured using magnetic resonance imaging iron-corrected T1 mapping (MRI cT1).
Time frame: Baseline to Weeks 52
Pre-dose Concentrations of RO7790121
Time frame: Weeks 0, 2, 6, 10, 14, 26, and 38
Maximum Concentration (Cmax) of RO7790121
Time frame: Weeks 0, 2, 6, 10, 52 and 62
Minimum Concentration (Cmin) of RO7790121
Time frame: Weeks 0, 2, 6, 10, 52 and 62
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