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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO7790121 | Experimental | Particiapants will receive RO7790121 via intravenous (IV) infusion followed by subcutaneous (SC) injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7790121 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) | Up to Week 52 after Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Liver Stiffness | Liver stiffness will be measured by transient elastography (FibroScan® or FibroTouch®) and indicated in kilopascals (kPa). | Baseline to Week 52 |
| Change from Baseline in Serum Levels of Propeptide of Type lll Collagen (Pro-C3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adobe Clinical Research, LLC | Tucson | Arizona | 85712 | United States | ||
| Gastrointestinal Specialists of Georgia, PC |
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| Baseline to Week 52 |
| Change from Baseline in Serum Enhanced Liver Fibrosis (ELF) Test | 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). | Baseline to Weeks 52 |
| 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 |
| Marietta |
| Georgia |
| 30060 |
| United States |
| Delta Research Partners, LLC (Bastrop) | Bastrop | Louisiana | 71220 | United States |
| Jubilee Clinical Research NV, LLC | Las Vegas | Nevada | 89106 | United States |
| Innovative Clinical Research | Clarksville | Tennessee | 37040 | United States |
| Pinnacle Clinical Research - Austin | Austin | Texas | 78757 | United States |
| Bellaire Clinical Research, LLC | Bellaire | Texas | 77401 | United States |
| DHR Health Institute for Research and Development | Edinburg | Texas | 78539 | United States |
| Pinnacle Clinical Research Georgetown | Georgetown | Texas | 78626 | United States |
| Pinnacle Clinical Research, PLLC | San Antonio | Texas | 78229 | United States |
| GI Alliance | Southlake | Texas | 76092 | United States |
| Centro de Investigacion y Gastroenterologia | Mexico City | Mexico CITY (federal District) | 06700 | Mexico |
| Fundacion Santos Y De La Garza Evia IBP | San Pedro Garza García | Nuevo León | 66278 | Mexico |
| FDI Clinicial Research - Mayaguez | Mayagez | 00680 | Puerto Rico |
| Fundacion de Investigacion de Diego | San Juan | 00927 | Puerto Rico |