Status:
ACTIVE_NOT_RECRUITING
A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Participants With Advanced MASH Liver Fibrosis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
MASH
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06903065
Start Date
April 14 2025
End Date
December 30 2026
Last Update
January 8 2026
Active Locations (24)
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1
Adobe Clinical Research, LLC
Tucson, Arizona, United States, 85712
2
Gastro Health Research - Miami
Miami, Florida, United States, 33176
3
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States, 30060
4
Delta Research Partners, LLC (Bastrop)
Bastrop, Louisiana, United States, 71220