A Phase 3 interventional study of Pegozafermin and Placebo in Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis, sponsored by Hoffmann-La Roche. Recruiting at 330 sites in 25 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's planned enrollment of 1,800 is above the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 23, 2026. See what changed
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Pegozafermin
Matched placebo
Drug: Placebo
Subcutaneous injection
Also known as: BIO89-100, RO7948410
Subcutaneous injection
Proportion of Participants Achieving Fibrosis Regression
Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy.
Time frame: Baseline through Month 24
Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events
Time frame: Baseline up to 5 years
Change from Baseline in Enhanced Liver Fibrosis (ELF) Score
Time frame: Baseline, up to Month 60
Change from Baseline in Alanine Aminotransferase (ALT) Level
Time frame: Baseline, up to Month 60
Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE)
Time frame: Baseline, up to Month 60
Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH)
Time frame: Baseline, up to Month 60
Time to Progression to Large Gastric or Esophageal Varices or Endoscopic Treatment of Esophageal or Gastric Varices
Time frame: Baseline, up to Month 60
Time to Clinically Important Ascites
Time to clinically important ascites as determined by the onset of Grade ≥2 (clinically apparent) ascites leading to diagnostic paracentesis or initiation of specific treatment for ascites.
Time frame: Baseline, up to Month 60
Time to Overt Hepatic Encephalopathy
Time frame: Baseline, up to Month 60
Frequency and Severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline, up to 5 years
Frequency and Severity of Serious Adverse Events (SAEs)
Time frame: Baseline, up to 5 years
Overall Frequency and Severity of Treatment-Related TEAEs
Time frame: Baseline, up to Month 60
Overall Frequency and Severity of Treatment-Related SAEs
Time frame: Baseline, up to Month 60
Proportion of Participants who Discontinue Treatment Due to Treatment-Related Adverse Events (AEs)
Time frame: Baseline, up to Month 60
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Showing the first 100 of 330 sites across 25 countries. Choose a country and city above to see the rest.
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Jun 2028, 49 months after the start.
Of 34 phase 3 interventional studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 61. This study's planned 49 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Pegozafermin
Non-alcoholic Fatty Liver Disease →