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

NCT06903065

Active Not RecruitingPhase 1

Sponsor: Hoffmann-La Roche

Conditions: MASH

Interventions: RO7790121

Countries: United States, Mexico, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (15)

Tucson, Arizona, United States
Marietta, Georgia, United States
Bastrop, Louisiana, United States
Las Vegas, Nevada, United States
Clarksville, Tennessee, United States
Austin, Texas, United States
Bellaire, Texas, United States
Georgetown, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
Southlake, Texas, United States
Mexico City, Mexico CITY (federal District), Mexico
San Pedro Garza García, Nuevo León, Mexico
Mayagez, Puerto Rico
San Juan, Puerto Rico