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RO7790121

Phase 1

MASH | Small molecule | Metabolic |Roche Holding AG|Last Updated: Jul 15, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

RO7790121 · 1 trial · 1 indication

Phase 1 1
NCT06903065A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Participants With Advanced MASH Liver FibrosisMASH
ACTIVE NOT_RECRUITING50 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Participants With Advanced MASH Liver Fibrosis
MASH
NCT0690306550
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Study Endpoints

Primary Endpoints

Percentage of Participants with Adverse Events (AEs)
Up to Week 52 after Baseline

Secondary Endpoints

Change from Baseline in Liver Stiffness
Baseline to Week 52
Change from Baseline in Serum Levels of Propeptide of Type lll Collagen (Pro-C3)
Baseline to Week 52
Change from Baseline in Serum Enhanced Liver Fibrosis (ELF) Test
Baseline to Week 52
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RO7790121EXPERIMENTALParticiapants will receive RO7790121 via intravenous (IV) infusion followed by subcutaneous (SC) injections.

Interventions

NameTypeDescription
RO7790121DRUGParticipants 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.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites15

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 Crite...

Countries:United StatesMexicoPuerto Rico
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Frequently asked questions about RO7790121

What is RO7790121 used for?

RO7790121 is an investigational small molecule being developed for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), specifically in participants with advanced MASH liver fibrosis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes RO7790121?

RO7790121 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 1 clinical trial to evaluate the safety, pharmacokinetics, and activity of this investigational small molecule in patients with advanced MASH liver fibrosis.

What phase is RO7790121 in?

RO7790121 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 study is active but not recruiting participants, and it is designed to assess safety, pharmacokinetics, and activity.

What clinical trials is RO7790121 in?

RO7790121 is being studied in one active Phase 1 clinical trial with the identifier NCT06903065. The trial is titled 'A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Participants With Advanced MASH Liver Fibrosis' and is enrolling approximately 50 participants in the United States, Mexico, and Puerto Rico.

Is RO7790121 FDA approved?

No, RO7790121 is not FDA approved. It is an investigational small molecule currently in Phase 1 clinical development for MASH with advanced liver fibrosis. The drug is being studied in an active clinical trial, but it has not yet received regulatory approval for any use.