MASH
Conditions
Brief 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.
Interventions
DRUGRO7790121
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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events (AEs) | Up to Week 52 after Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Liver Stiffness | Baseline to Week 52 | Liver stiffness will be measured by transient elastography (FibroScan® or FibroTouch®) and indicated in kilopascals (kPa). |
| Change from Baseline in Serum Levels of Propeptide of Type lll Collagen (Pro-C3) | Baseline to Week 52 | — |
| Change from Baseline in Serum Enhanced Liver Fibrosis (ELF) Test | Baseline to Week 52 | — |
| Change from Baseline in Fibro-inflammation | Baseline to Weeks 52 | Fibro-inflammation will be measured using magnetic resonance imaging iron-corrected T1 mapping (MRI cT1). |
| Pre-dose Concentrations of RO7790121 | Weeks 0, 2, 6, 10, 14, 26, and 38 | — |
| Maximum Concentration (Cmax) of RO7790121 | Weeks 0, 2, 6, 10, 52 and 62 | — |
| Minimum Concentration (Cmin) of RO7790121 | Weeks 0, 2, 6, 10, 52 and 62 | — |
Countries
Mexico, Puerto Rico, United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed