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

NCT06903065 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: CC45687
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 15

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.

Conditions

MASH

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Adverse Events (AEs)

  Up to Week 52 after Baseline

Secondary Outcomes (7)

• Change from Baseline in Liver Stiffness

  Baseline to Week 52

• 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

• Pre-dose Concentrations of RO7790121

  Weeks 0, 2, 6, 10, 14, 26, and 38

Study Arms (1)

RO7790121

EXPERIMENTAL

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

Drug: RO7790121

Interventions

RO7790121 DRUG

Participants will be administered RO7790121 via IV infusion on Day 1, and Weeks 2, 6 and 10. Participants will then be administered RO7790121 SC injections every four weeks (Q4W) from week 14 up to and including Week 50.

Also known as: PF-06480605, RVT-3101, RG6631

RO7790121

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (15)

Adobe Clinical Research, LLC

Tucson, Arizona, 85712, United States

Location

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, 30060, United States

Location

Delta Research Partners, LLC (Bastrop)

Bastrop, Louisiana, 71220, United States

Location

Jubilee Clinical Research NV, LLC

Las Vegas, Nevada, 89106, United States

Location

Innovative Clinical Research

Clarksville, Tennessee, 37040, United States

Location

Pinnacle Clinical Research - Austin

Austin, Texas, 78757, United States

Location

Bellaire Clinical Research, LLC

Bellaire, Texas, 77401, United States

Location

DHR Health Institute for Research and Development

Edinburg, Texas, 78539, United States

Location

Pinnacle Clinical Research Georgetown

Georgetown, Texas, 78626, United States

Location

Pinnacle Clinical Research, PLLC

San Antonio, Texas, 78229, United States

Location

GI Alliance

Southlake, Texas, 76092, United States

Location

Centro de Investigacion y Gastroenterologia

Mexico City, Mexico CITY (federal District), 06700, Mexico

Location

Fundacion Santos Y De La Garza Evia IBP

San Pedro Garza García, Nuevo León, 66278, Mexico

Location

FDI Clinicial Research - Mayaguez

Mayagez, 00680, Puerto Rico

Location

Fundacion de Investigacion de Diego

San Juan, 00927, Puerto Rico

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 30, 2025
• Study Start: April 14, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2); PR (2); US (11)