MASHPhase 1NCT06903065
A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Participants With Advanced MASH Liver Fibrosis
A Phase 1 study testing RO7790121 in people with MASH, run by Hoffmann-La Roche at 15 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MASH
- What is being tested?
- RO7790121
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 14 Apr 2025to 3 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States11 sites
Pinnacle Clinical Research - Austin
Austin, Texas, 78757
Delta Research Partners, LLC (Bastrop)
Bastrop, Louisiana, 71220
Bellaire Clinical Research, LLC
Bellaire, Texas, 77401
Innovative Clinical Research
Clarksville, Tennessee, 37040
Pinnacle Clinical Research Georgetown
Georgetown, Texas, 78626
Jubilee Clinical Research NV, LLC
Las Vegas, Nevada, 89106
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060
DHR Health Institute for Research and Development
McAllen, Texas, 78504
Pinnacle Clinical Research, PLLC
San Antonio, Texas, 78229
GI Alliance
Southlake, Texas, 76092
Adobe Clinical Research, LLC
Tucson, Arizona, 85712
Mexico2 sites
Centro de Investigacion y Gastroenterologia
Mexico City, Mexico CITY (federal District), 06700
Fundacion Santos Y De La Garza Evia IBP
San Pedro Garza García, Nuevo León, 66278
Puerto Rico2 sites
FDI Clinicial Research - Mayaguez
Mayagez, 00680
Fundacion de Investigacion de Diego
San Juan, 00927
About this study
Official 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
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.
- Conditions
- MASH
- Being tested
- RO7790121
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7790121Drug
Also called PF-06480605, RVT-3101, RG6631
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 group | Role | What they receive |
|---|---|---|
| RO7790121 | Experimental | Particiapants will receive RO7790121 via intravenous (IV) infusion followed by subcutaneous (SC) injections. Receives: Drug: RO7790121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events (AEs)
Measured: Up to Week 52 after Baseline
Secondary outcomes (7)
Change from Baseline in Liver Stiffness
Liver stiffness will be measured by transient elastography (FibroScan® or FibroTouch®) and indicated in kilopascals (kPa).
Measured: Baseline to Week 52
Change from Baseline in Serum Levels of Propeptide of Type lll Collagen (Pro-C3)
Measured: Baseline to Week 52
Change from Baseline in Serum Enhanced Liver Fibrosis (ELF) Test
Measured: Baseline to Week 52
Change from Baseline in Fibro-inflammation
Fibro-inflammation will be measured using magnetic resonance imaging iron-corrected T1 mapping (MRI cT1).
Measured: Baseline to Weeks 52
Pre-dose Concentrations of RO7790121
Measured: Weeks 0, 2, 6, 10, 14, 26, and 38
Maximum Concentration (Cmax) of RO7790121
Measured: Weeks 0, 2, 6, 10, 52 and 62
Minimum Concentration (Cmin) of RO7790121
Measured: Weeks 0, 2, 6, 10, 52 and 62
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start14 Apr 2025
- Primary completion24 Sep 2026
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASHStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903065
- Sponsor's protocol ID
- CC45687
- Status last verified
- Oct 2026
- First submitted
- 18 Mar 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06903065
- Acronym / sponsor ID
- CC45687
- Conditions
- MASH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 24 Sep 2026 (actual)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RO7790121 | Experimental | Drug: RO7790121Particiapants will receive RO7790121 via intravenous (IV) infusion followed by subcutaneous (SC) injections. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7790121Also: PF-06480605, RVT-3101, RG6631Participants 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. | Drug | RO7790121 |
Primary outcome
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to Week 52 after Baseline
7 secondary outcomes
Change from Baseline in Liver Stiffness
Time frame: Baseline to Week 52
Change from Baseline in Serum Levels of Propeptide of Type lll Collagen (Pro-C3)
Time frame: Baseline to Week 52
Change from Baseline in Serum Enhanced Liver Fibrosis (ELF) Test
Time frame: Baseline to Week 52
Change from Baseline in Fibro-inflammation
Time frame: Baseline to Weeks 52
Pre-dose Concentrations of RO7790121
Time frame: Weeks 0, 2, 6, 10, 14, 26, and 38
Maximum Concentration (Cmax) of RO7790121
Time frame: Weeks 0, 2, 6, 10, 52 and 62
Minimum Concentration (Cmin) of RO7790121
Time frame: Weeks 0, 2, 6, 10, 52 and 62
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7790121 in people with MASH, run by Hoffmann-La Roche at 15 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Mexico, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Adverse Events (AEs) (time frame: Up to Week 52 after Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.