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

July 14, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
      • Georgetown, Texas, United States, 78626
        • Pinnacle Clinical Research Georgetown
      • McAllen, Texas, United States, 78504
        • DHR Health Institute for Research and Development
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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