A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Participants With Advanced MASH Liver Fibrosis
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT06903065
- Phase
- PHASE1
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- RO7790121 — DRUGParticipants 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 Details
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.
Key Dates
- Start date
- Apr 14, 2025
- Status verified
- Apr 2026
- Primary completion
- Sep 30, 2026
- Completion
- Dec 30, 2026
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: RO7790121Particiapants will receive RO7790121 via intravenous (IV) infusion followed by subcutaneous (SC) injections.
Primary Outcome Measure
Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to Week 52 after Baseline ]
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Adobe Clinical Research, LLC | Tucson | Arizona | 85712 | - |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | - |
| Delta Research Partners, LLC (Bastrop) | Bastrop | Louisiana | 71220 | - |
| Jubilee Clinical Research NV, LLC | Las Vegas | Nevada | 89106 | - |
| Innovative Clinical Research | Clarksville | Tennessee | 37040 | - |
| Pinnacle Clinical Research - Austin | Austin | Texas | 78757 | - |
| Bellaire Clinical Research, LLC | Bellaire | Texas | 77401 | - |
| DHR Health Institute for Research and Development | Edinburg | Texas | 78539 | - |
| Pinnacle Clinical Research Georgetown | Georgetown | Texas | 78626 | - |
| Pinnacle Clinical Research, PLLC | San Antonio | Texas | 78229 | - |
| GI Alliance | Southlake | Texas | 76092 | - |
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