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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT06903065
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • RO7790121 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 14, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RO7790121
    Particiapants will receive RO7790121 via intravenous (IV) infusion followed by subcutaneous (SC) injections.

Primary Outcome Measure

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

Locations (11)

FacilityCityStateZIPSite coordinators
Adobe Clinical Research, LLCTucsonArizona85712-
Gastrointestinal Specialists of Georgia, PCMariettaGeorgia30060-
Delta Research Partners, LLC (Bastrop)BastropLouisiana71220-
Jubilee Clinical Research NV, LLCLas VegasNevada89106-
Innovative Clinical ResearchClarksvilleTennessee37040-
Pinnacle Clinical Research - AustinAustinTexas78757-
Bellaire Clinical Research, LLCBellaireTexas77401-
DHR Health Institute for Research and DevelopmentEdinburgTexas78539-
Pinnacle Clinical Research GeorgetownGeorgetownTexas78626-
Pinnacle Clinical Research, PLLCSan AntonioTexas78229-
GI AllianceSouthlakeTexas76092-

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