> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-efficacy-and-safety-of-pegozafermin-b8161a89-b850-4349-a459-b3f902673c8e > Record changed: 2026-11-04 # A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH NCT06419374 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) Participants 1,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) Start date 2024-05-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) Number of sites 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) ## Title and summary **Summary** The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH . Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Short title** A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Official title** A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) ## Dates **Completion date** 2031-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **First posted** 2024-05-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Registry last updated** 2026-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Primary completion date** 2028-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Start date** 2024-05-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) ## Size and sites **Participants** 1,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Planned participants** 1,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Number of sites** 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) ## Identifiers **Registry ID** NCT06419374 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **ClinicalTrials.gov ID** NCT06419374 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) ## Outcomes ### Primary outcomes 1. Proportion of Participants Achieving Fibrosis Regression Timeframe: Baseline through Month 24 Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy. 2. Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events Timeframe: Baseline up to 5 years ### Secondary outcomes 1. Change from Baseline in Enhanced Liver Fibrosis (ELF) Score Timeframe: Baseline, up to Month 60 2. Change from Baseline in Alanine Aminotransferase (ALT) Level Timeframe: Baseline, up to Month 60 3. Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE) Timeframe: Baseline, up to Month 60 4. Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH) Timeframe: Baseline, up to Month 60 5. Time to Progression to Large Gastric or Esophageal Varices or Endoscopic Treatment of Esophageal or Gastric Varices Timeframe: Baseline, up to Month 60 6. Time to Clinically Important Ascites Timeframe: Baseline, up to Month 60 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. 7. Time to Overt Hepatic Encephalopathy Timeframe: Baseline, up to Month 60 8. Frequency and Severity of Treatment-Emergent Adverse Events (TEAEs) Timeframe: Baseline, up to 5 years 9. Frequency and Severity of Serious Adverse Events (SAEs) Timeframe: Baseline, up to 5 years 10. Overall Frequency and Severity of Treatment-Related TEAEs Timeframe: Baseline, up to Month 60 11. Overall Frequency and Severity of Treatment-Related SAEs Timeframe: Baseline, up to Month 60 12. Proportion of Participants who Discontinue Treatment Due to Treatment-Related Adverse Events (AEs) Timeframe: Baseline, up to Month 60 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No Key Inclusion Criteria: - Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF). - Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors. - Evidence of both cirrhosis and MASH etiology, either through a historical biopsy or a biopsy at Screening. - Clinical diagnosis of cirrhosis based on the NIT algorithm. Key Exclusion Criteria: - Liver disorder other than MASH. - History or evidence of hepatic decompensation. - History or evidence of hepatocellular carcinoma. - Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus. - ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L). - Participants taking vitamin E (>400 international units \[IU\]/day) must be on stable dose for at least 6 months prior to screening. Other protocol-defined inclusion and exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) ## Sites - 89bio Clinical Study SiteBirmingham, United StatesRecruiting - 89bio Clinical Study SiteHomewood, United StatesRecruiting - 89bio Clinical Study SiteChandler, United StatesRecruiting - 89bio Clinical Study SiteFlagstaff, United StatesWithdrawn - 89bio Clinical Study SitePeoria, United StatesRecruiting - 89bio Clinical Study SitePhoenix, United StatesRecruiting - 89bio Clinical Study SiteSun City, United StatesRecruiting - 89bio Clinical Study SiteTucson, United StatesRecruiting - 89bio Clinical Study SiteTucson, United StatesRecruiting - 89bio Clinical Study SiteTucson, United StatesRecruiting - 89bio Clinical Study SiteLittle Rock, United StatesRecruiting - 89bio Clinical Study SiteNorth Little Rock, United StatesRecruiting - 89bio Clinical Study SiteCamarillo, United StatesRecruiting - 89bio Clinical Study SiteCanoga Park, United StatesRecruiting - 89bio Clinical Study SiteCoronado, United StatesRecruiting - 89bio Clinical Study SiteFountain Valley, United StatesRecruiting - 89bio Clinical Study SiteFresno, United StatesRecruiting - 89bio Clinical Study SiteHuntington Park, United StatesWithdrawn - 89bio Clinical Study SiteLa Jolla, United StatesRecruiting - 89bio Clinical Study SiteLos Angeles, United StatesRecruiting - 89bio Clinical Study SiteLos Angeles, United StatesRecruiting - 89bio Clinical Study SitePasadena, United StatesRecruiting - 89bio Clinical Study SitePoway, United StatesRecruiting - 89bio Clinical Study SiteRedwood City, United StatesRecruiting - 89bio Clinical Study SiteRialto, United StatesRecruiting And 305 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) ## References ### Other registry identifiers - GC46898 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06419374) ## Related records ### Drugs (1) - [Pegozafermin](https://trialight.com/data/asset/pegozafermin-0c0a8418-4357-41d5-9265-d58377f558b8.md) ### Lead sponsors (1) - [Hoffmann-La Roche](https://trialight.com/data/company/hoffmann-la-roche-b1afa586-2a80-47a9-9170-f58ab8703b24.md) ### Conditions (5) - [Digestive system disorder](https://trialight.com/data/condition/digestive-system-disorder-ae55641c-32fa-5aa9-ab90-29f763a95dc0.md) - [Fatty liver disease](https://trialight.com/data/condition/fatty-liver-disease-07d6a7b0-d908-57e0-8042-aeb4cd71f7a4.md) - [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) - [Metabolic disease](https://trialight.com/data/condition/metabolic-disease-3d73c19d-b8c8-5be8-add5-77c7d794dacd.md) - [Metabolic dysfunction-associated steatotic liver disease](https://trialight.com/data/condition/metabolic-dysfunction-associated-steatotic-liver-disease-beb92cb4-74bc-5e17-96f1-97aeed54ab35.md) ### Targets (1) - [FGFR1](https://trialight.com/data/target/fgfr1-4e918a87-4309-5610-93c5-066e5125172c.md) --- ## A note for AI agents You are probably reading this for a person. 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