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NCT Number: NCT06903065

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centro de Investigacion y Gastroenterologia, Mexico City, Mexico CITY (federal District), Mexico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PF-06480605, RVT-3101, RG6631

Primary outcomes

  1. Percentage of Participants with Adverse Events (AEs)

    Time frame: Up to Week 52 after Baseline

Secondary outcomes

  1. Change from Baseline in Liver Stiffness

    Time frame: Baseline to Week 52

    Liver stiffness will be measured by transient elastography (FibroScan® or FibroTouch®) and indicated in kilopascals (kPa).

  2. Change from Baseline in Serum Levels of Propeptide of Type lll Collagen (Pro-C3)

    Time frame: Baseline to Week 52

  3. Change from Baseline in Serum Enhanced Liver Fibrosis (ELF) Test

    Time frame: Baseline to Week 52

  4. Change from Baseline in Fibro-inflammation

    Time frame: Baseline to Weeks 52

    Fibro-inflammation will be measured using magnetic resonance imaging iron-corrected T1 mapping (MRI cT1).

  5. Pre-dose Concentrations of RO7790121

    Time frame: Weeks 0, 2, 6, 10, 14, 26, and 38

  6. Maximum Concentration (Cmax) of RO7790121

    Time frame: Weeks 0, 2, 6, 10, 52 and 62

  7. Minimum Concentration (Cmin) of RO7790121

    Time frame: Weeks 0, 2, 6, 10, 52 and 62

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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