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Clinical Trials in the USA / NCT06903065
Active, not recruiting Phase 1

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

NCT06903065 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 1
Started
2025-04-14
Last updated
2026-07-15

Condition(s) studied

MASH

Investigational drug(s) / intervention(s)

RO7790121

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Adobe Clinical Research, LLC Tucson Arizona
Gastrointestinal Specialists of Georgia, PC Marietta Georgia
Delta Research Partners, LLC (Bastrop) Bastrop Louisiana
Jubilee Clinical Research NV, LLC Las Vegas Nevada
Innovative Clinical Research Clarksville Tennessee
Pinnacle Clinical Research - Austin Austin Texas
Bellaire Clinical Research, LLC Bellaire Texas
Pinnacle Clinical Research Georgetown Georgetown Texas
DHR Health Institute for Research and Development McAllen Texas
Pinnacle Clinical Research, PLLC San Antonio Texas
GI Alliance Southlake Texas
Centro de Investigacion y Gastroenterologia Mexico City Mexico CITY (federal District)
Fundacion Santos Y De La Garza Evia IBP San Pedro Garza García Nuevo León
FDI Clinicial Research - Mayaguez Mayagez Puerto Rico
Fundacion de Investigacion de Diego San Juan Puerto Rico

More Hoffmann-La Roche trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06903065 on ClinicalTrials.gov ↗ ← All trials in the USA