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

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.

Conditions

MASH

Study Overview

Study Details

Study overview

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.

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

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

Condition
MASH
Intervention / Treatment

-

Contacts and Locations

Las Vegas

Jubilee Clinical Research, Inc, Las Vegas, Nevada, United States, 89106

Austin

Pinnacle Clinical Research - Austin, Austin, Texas, United States, 78757

Georgetown

Pinnacle Clinical Research Georgetown, Georgetown, Texas, United States, 78626

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoffmann-La Roche,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2026-09-30