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ACTIVE NOT RECRUITING
NCT06903065
PHASE1

A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Participants With Advanced MASH Liver Fibrosis

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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

DRUG

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