ACTIVE_NOT_RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-04-14

Study Completion:2026-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06903065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Hoffmann-La Roche

Study Locations (Sites)

Adobe Clinical Research, LLC

Tucson, Arizona, 85712

United States

Gastro Health Research - Miami

Miami, Florida, 33176

United States

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, 30060

United States

Delta Research Partners, LLC (Bastrop)

Bastrop, Louisiana, 71220

United States

Jubilee Clinical Research, Inc

Las Vegas, Nevada, 89106

United States

Premier Medical Group Int Medcn

Clarksville, Tennessee, 37040

United States

Gastroenterology Center of the MidSouth PC

Cordova, Tennessee, 38018

United States

Pinnacle Clinical Research - Austin

Austin, Texas, 78757

United States

Bellaire Clinical Research, LLC

Bellaire, Texas, 77401

United States

DHR Health Institute for Research and Development

Edinburg, Texas, 78539

United States

Pinnacle Clinical Research Georgetown

Georgetown, Texas, 78626

United States

Houston Research Institute

Houston, Texas, 77079

United States

Pinnacle Clinical Research, PLLC

San Antonio, Texas, 78229

United States

GI Alliance

Southlake, Texas, 76092

United States

GI Alliance

Bellevue, Washington, 98004

United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-14

Study Completion Date2026-12-30

Study Record Updates

Study Start Date2025-04-14

Study Completion Date2026-12-30

Terms related to this study

Additional Relevant MeSH Terms

MASH