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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)
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 1
Study Identifier
NCT06903065, CC45687
Condition
MASH
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
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
All
≥18 Years & ≤ 75 Years
No
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
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 information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com