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New drug trial targets liver scarring in MASH patients

NCT ID NCT06903065

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This early-stage study tests a new medicine called RO7790121 in 50 adults with advanced liver scarring from MASH (a type of fatty liver disease). The main goal is to see if the drug is safe and how the body processes it. Researchers will also check if it can reduce liver stiffness and improve markers of liver damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MASH

Contacts and locations

Locations

  • Adobe Clinical Research, LLC

    Tucson, Arizona, 85712, United States

  • Bellaire Clinical Research, LLC

    Bellaire, Texas, 77401, United States

  • Centro de Investigacion y Gastroenterologia

    Mexico City, Mexico CITY (federal District), 06700, Mexico

  • DHR Health Institute for Research and Development

    McAllen, Texas, 78504, United States

  • Delta Research Partners, LLC (Bastrop)

    Bastrop, Louisiana, 71220, United States

  • FDI Clinicial Research - Mayaguez

    Mayagez, 00680, Puerto Rico

  • Fundacion Santos Y De La Garza Evia IBP

    San Pedro Garza García, Nuevo León, 66278, Mexico

  • Fundacion de Investigacion de Diego

    San Juan, 00927, Puerto Rico

  • GI Alliance

    Southlake, Texas, 76092, United States

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060, United States

  • Innovative Clinical Research

    Clarksville, Tennessee, 37040, United States

  • Jubilee Clinical Research NV, LLC

    Las Vegas, Nevada, 89106, United States

  • Pinnacle Clinical Research - Austin

    Austin, Texas, 78757, United States

  • Pinnacle Clinical Research Georgetown

    Georgetown, Texas, 78626, United States

  • Pinnacle Clinical Research, PLLC

    San Antonio, Texas, 78229, United States

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