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

Roche

Status and phase: Enrolling; Phase 1

Conditions: MASH

Treatments: Drug: RO7790121

Study type: Interventional

Funder types: Industry

Identifiers

NCT06903065

CC45687

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

RO7790121

Experimental group

Description:

Particiapants will receive RO7790121 via intravenous (IV) infusion followed by subcutaneous (SC) injections.

Treatment:

Drug: RO7790121