A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Participants With Advanced MASH Liver Fibrosis
NCT ID: NCT06903065
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2025-04-14
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RO7790121
Particiapants will receive RO7790121 via intravenous (IV) infusion followed by subcutaneous (SC) injections.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Adobe Clinical Research, LLC
Tucson, Arizona, United States
Gastro Health Research - Miami
Miami, Florida, 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
Gastroenterology Center of the MidSouth PC
Cordova, 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
GI Alliance
Bellevue, Washington, United States
CIMAB S.A. de C.V.
Torreón, Coahuila, Mexico
Centro de Investigacion Clinica y Medicina Traslacional CIMeT
Guadalajara, Jalisco, Mexico
Hospital General de Occidente SSJ
Zapopan, Jalisco, Mexico
Inovacion y Desarrollo en ciencias de la salud
Ciudad de Mxico, Mexico CITY (federal District), Mexico
Centro de Investigacion y Gastroenterologia
Mexico City, Mexico CITY (federal District), Mexico
Clínica de Enfermedades Crónicas y de Procedimientos Especiales, S.C (CECYPE)
Morelia, Michoacán, Mexico
Fundacion Santos Y De La Garza Evia IBP
San Pedro Garza García, Nuevo León, Mexico
Mediadvance Clinical SAPI De CV
Chihuahua City, , Mexico
FDI Clinicial Research - Mayaguez
Mayagez, , Puerto Rico
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Countries
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Other Identifiers
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CC45687
Identifier Type: -
Identifier Source: org_study_id
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