RO7790121: 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Percentage of Participants with Adverse Events (AEs) — Up to Week 52 after Baseline
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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