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

April 15, 2026 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Mexico CITY (federal District)
      • Mexico City, Mexico CITY (federal District), Mexico, 06700
        • Centro de Investigación y Gastroenterología
    • Nuevo León
      • San Pedro Garza García, Nuevo León, Mexico, 66278
        • Fundacion Santos Y De La Garza Evia IBP
  • Puerto Rico
      • Mayagez, Puerto Rico, 00680
        • FDI Clinicial Research - Mayaguez
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Adobe Clinical Research, LLC
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia, PC
    • Louisiana
      • Bastrop, Louisiana, United States, 71220
        • Delta Research Partners, LLC (Bastrop)
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Jubilee Clinical Research NV, LLC
    • Tennessee
      • Clarksville, Tennessee, United States, 37040
        • Innovative Clinical Research
    • Texas
      • Austin, Texas, United States, 78757
        • Pinnacle Clinical Research - Austin
      • Bellaire, Texas, United States, 77401
        • Bellaire Clinical Research, LLC
      • Edinburg, Texas, United States, 78539
        • DHR Health Institute for Research and Development
      • Georgetown, Texas, United States, 78626
        • Pinnacle Clinical Research Georgetown
      • San Antonio, Texas, United States, 78229
        • Pinnacle Clinical Research, PLLC
      • Southlake, Texas, United States, 76092
        • GI Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RO7790121
Particiapants will receive RO7790121 via intravenous (IV) infusion followed by subcutaneous (SC) injections.
Drug: RO7790121
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.
Other Names:
  • RVT-3101
  • PF-06480605
  • RG6631

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Adverse Events (AEs)
Time Frame: Up to Week 52 after Baseline
Up to Week 52 after Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC45687

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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