Clinical trial NCT06903065: A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Participants With Advanced MASH Liver Fibrosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: MASH
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2025-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to Week 52 after Baseline
Secondary outcomes:
measure: Change from Baseline in Liver Stiffness
timeFrame: Baseline to Week 52
measure: Change from Baseline in Serum Levels of Propeptide of Type lll Collagen (Pro-C3)
timeFrame: Baseline to Week 52
measure: Change from Baseline in Serum Enhanced Liver Fibrosis (ELF) Test
timeFrame: Baseline to Week 52
measure: Change from Baseline in Fibro-inflammation
timeFrame: Baseline to Weeks 52
measure: Pre-dose Concentrations of RO7790121
timeFrame: Weeks 0, 2, 6, 10, 14, 26, and 38
measure: Maximum Concentration (Cmax) of RO7790121
timeFrame: Weeks 0, 2, 6, 10, 52 and 62
measure: Minimum Concentration (Cmin) of RO7790121
timeFrame: Weeks 0, 2, 6, 10, 52 and 62
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Adobe Clinical Research, LLC
state: Arizona
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Bastrop
country: United States
facility: Delta Research Partners, LLC (Bastrop)
state: Louisiana
city: Las Vegas
country: United States
facility: Jubilee Clinical Research, Inc
state: Nevada
city: Clarksville
country: United States
facility: Premier Medical Group Int Medcn
state: Tennessee
city: Austin
country: United States
facility: Pinnacle Clinical Research - Austin
state: Texas
city: Bellaire
country: United States
facility: Bellaire Clinical Research, LLC
state: Texas
city: Edinburg
country: United States
facility: DHR Health Institute for Research and Development
state: Texas
city: Georgetown
country: United States
facility: Pinnacle Clinical Research Georgetown
state: Texas
city: Houston
country: United States
facility: Houston Research Institute
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research, PLLC
state: Texas
city: Southlake
country: United States
facility: GI Alliance
state: Texas
city: Bellevue
country: United States
facility: GI Alliance
state: Washington
city: Mayagez
country: Puerto Rico
facility: FDI Clinicial Research - Mayaguez
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: