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

Last updated: May 15, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

1

Condition

Hepatic Fibrosis

Hyponatremia

Treatment

RO7790121

Clinical Study ID

NCT06903065
CC45687
  • Ages 18-75
  • All Genders

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 Criteria

Inclusion

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

Exclusion Criteria:

  • Weight gain or loss >5% in the 3 months prior to baseline or >10% in the 6 monthsprior 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 ofliver 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 ofmalignancies with a negligible risk of metastasis or death

  • Current, significant alcohol consumption or a history of significant alcoholconsumption for a period of more than 3 consecutive months any time within 1 yearprior to screening

  • Initiation of a medication of an antidiabetic, weight loss, lipid-modifying oranti-depressant drug class

  • Active tuberculosis requiring treatment within the 12 months prior to baseline

  • History of organ transplant

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: RO7790121
Phase: 1
Study Start date:
April 14, 2025
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • FDI Clinicial Research - Mayaguez

    Mayagez, 00680
    Puerto Rico

    Active - Recruiting

  • Fundacion de Investigacion de Diego

    San Juan, 00927
    Puerto Rico

    Active - Recruiting

  • Adobe Clinical Research, LLC

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Delta Research Partners, LLC (Bastrop)

    Bastrop, Louisiana 71220
    United States

    Active - Recruiting

  • Jubilee Clinical Research, Inc

    Las Vegas, Nevada 89106
    United States

    Active - Recruiting

  • Premier Medical Group Int Medcn

    Clarksville, Tennessee 37040
    United States

    Active - Recruiting

  • Pinnacle Clinical Research - Austin

    Austin, Texas 78757
    United States

    Active - Recruiting

  • Bellaire Clinical Research, LLC

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • DHR Health Institute for Research and Development

    Edinburg, Texas 78539
    United States

    Active - Recruiting

  • Pinnacle Clinical Research Georgetown

    Georgetown, Texas 78626
    United States

    Active - Recruiting

  • Houston Research Institute

    Houston, Texas 77079
    United States

    Active - Recruiting

  • Pinnacle Clinical Research, PLLC

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • GI Alliance

    Southlake, Texas 76092
    United States

    Active - Recruiting

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