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

Running, not enrolling · Phase 1

Conditions studied: MASH

In brief

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 facts

Study ID

NCT06903065

Run by

Hoffmann-La Roche

People needed

50

Starts

2025-04-14

Expected to finish

2026-12-30

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Adobe Clinical Research, LLC — Tucson, Arizona, United States
• Gastrointestinal Specialists of Georgia, PC — Marietta, Georgia, United States
• Delta Research Partners, LLC (Bastrop) — Bastrop, Louisiana, United States
• Jubilee Clinical Research NV, LLC — Las Vegas, Nevada, United States
• Innovative Clinical Research — Clarksville, Tennessee, United States
• Pinnacle Clinical Research - Austin — Austin, Texas, United States
• Bellaire Clinical Research, LLC — Bellaire, Texas, United States
• Pinnacle Clinical Research Georgetown — Georgetown, Texas, United States
• DHR Health Institute for Research and Development — McAllen, Texas, United States
• Pinnacle Clinical Research, PLLC — San Antonio, Texas, United States
• GI Alliance — Southlake, Texas, United States
• Centro de Investigacion y Gastroenterologia — Mexico City, Mexico CITY (federal District), Mexico
• Fundacion Santos Y De La Garza Evia IBP — San Pedro Garza García, Nuevo León, Mexico
• FDI Clinicial Research - Mayaguez — Mayagez, Puerto Rico
• Fundacion de Investigacion de Diego — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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