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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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:
    • PF-06480605
    • RVT-3101
    • RG6631

Recruiting Locations

Adobe Clinical Research, LLC
Tucson, Arizona 85712

Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia 30060

Delta Research Partners, LLC (Bastrop)
Bastrop, Louisiana 71220

Jubilee Clinical Research, Inc
Las Vegas, Nevada 89106

Premier Medical Group Int Medcn
Clarksville, Tennessee 37040

Pinnacle Clinical Research - Austin
Austin, Texas 78757

Bellaire Clinical Research, LLC
Bellaire, Texas 77401

DHR Health Institute for Research and Development
Edinburg, Texas 78539

Pinnacle Clinical Research Georgetown
Georgetown, Texas 78626

Houston Research Institute
Houston, Texas 77079

Pinnacle Clinical Research, PLLC
San Antonio, Texas 78229

GI Alliance
Southlake, Texas 76092

FDI Clinicial Research - Mayaguez
Mayagez, Puerto Rico 00680

Fundacion de Investigacion de Diego
San Juan, Puerto Rico 00927

More Details

NCT ID
NCT06903065
Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: CC45687 https://forpatients.roche.com/
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center