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A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Participants With Advanced MASH Liver Fibrosis
Sponsor: Hoffmann-La Roche
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.
Official title: A Phase Ib, Multicenter, Open-Label, Single-Arm Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Patients With Advanced MASH Liver Fibrosis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-04-14
Completion Date
2026-12-30
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (15)
Adobe Clinical Research, LLC
Tucson, Arizona, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Delta Research Partners, LLC (Bastrop)
Bastrop, Louisiana, United States
Jubilee Clinical Research NV, LLC
Las Vegas, Nevada, United States
Innovative Clinical Research
Clarksville, Tennessee, United States
Pinnacle Clinical Research - Austin
Austin, Texas, United States
Bellaire Clinical Research, LLC
Bellaire, Texas, United States
DHR Health Institute for Research and Development
Edinburg, Texas, United States
Pinnacle Clinical Research Georgetown
Georgetown, Texas, United States
Pinnacle Clinical Research, PLLC
San Antonio, Texas, United States
GI Alliance
Southlake, Texas, United States
Centro de Investigacion y Gastroenterologia
Mexico City, Mexico CITY (federal District), Mexico
Fundacion Santos Y De La Garza Evia IBP
San Pedro Garza García, Nuevo León, Mexico
FDI Clinicial Research - Mayaguez
Mayagez, Puerto Rico
Fundacion de Investigacion de Diego
San Juan, Puerto Rico