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

  • Metabolic Disorder
  • Metabolic dysfunction-associated steatohepatitis (MASH)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Recruiting

This study runs in
Cities
  • Austin
  • georgetown
  • Las Vegas
Trial Identifier:

NCT06903065 CC45687

      Show study locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      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.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT06903065, CC45687 Trial Identifier
      RO7790121 Treatments
      MASH Condition
      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

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 75 Years Age
      No Healthy Volunteers
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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