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

Phase 1

Recruiting

• Conditions: MASH
• Interventions: Drug: RO7790121

• Registration Number: NCT06903065
• Lead Sponsor: Hoffmann-La Roche

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 steatohepatitis (MASH) fibrosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-27
• Study First Posted: 2025-03-30
• Study Start: 2025-04-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Adverse Events (AEs)	Up to Week 52 after Baseline

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Liver Stiffness	Baseline to Week 52	Liver stiffness will be measured by transient elastography (FibroScan® or FibroTouch®) and indicated in kilopascals (kPa).
Change from Baseline in Serum Levels of Propeptide of Type lll Collagen (Pro-C3)	Baseline to Week 52
Change from Baseline in Serum Enhanced Liver Fibrosis (ELF) Test	Baseline to Week 52
Change from Baseline in Fibro-inflammation	Baseline to Weeks 52	Fibro-inflammation will be measured using magnetic resonance imaging iron-corrected T1 mapping (MRI cT1).
Pre-dose Concentrations of RO7790121	Weeks 0, 2, 6, 10, 14, 26, and 38
Maximum Concentration (Cmax) of RO7790121	Weeks 0, 2, 6, 10, 52 and 62
Minimum Concentration (Cmin) of RO7790121	Weeks 0, 2, 6, 10, 52 and 62

Trial Locations

Locations (14)

Adobe Clinical Research, LLC; 🇺🇸 Tucson, Arizona, United States

Premier Medical Group Int Medcn; 🇺🇸 Clarksville, Tennessee, United States

DHR Health Institute for Research and Development; 🇺🇸 Edinburg, Texas, United States

Houston Research Institute; 🇺🇸 Houston, Texas, United States

GI Alliance; 🇺🇸 Southlake, Texas, United States

FDI Clinicial Research - Mayaguez; 🇵🇷 Mayagez, Puerto Rico

Fundacion de Investigacion de Diego; 🇵🇷 San Juan, Puerto Rico

Gastrointestinal Specialists of Georgia, PC; 🇺🇸 Marietta, Georgia, United States

Delta Research Partners, LLC (Bastrop); 🇺🇸 Bastrop, Louisiana, United States

Jubilee Clinical Research, Inc; 🇺🇸 Las Vegas, Nevada, United States

Pinnacle Clinical Research - Austin; 🇺🇸 Austin, Texas, United States

Bellaire Clinical Research, LLC; 🇺🇸 Bellaire, Texas, United States

Pinnacle Clinical Research Georgetown; 🇺🇸 Georgetown, Texas, United States

Pinnacle Clinical Research, PLLC; 🇺🇸 San Antonio, Texas, United States