> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-evaluating-the-efficacy-and-safety-of-pegozafermin-3fb7252c-a8d9-4f3c-9a91-c646394418c3 > Record changed: 2026-10-13 # A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis) NCT06318169 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) Participants 1,350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) Lead sponsor 89bio, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) Start date 2024-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) Number of sites 365 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) ## Title and summary **Summary** The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Short title** A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Official title** A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) ## Dates **Completion date** 2029-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **First posted** 2024-03-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Registry last updated** 2026-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Primary completion date** 2029-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Start date** 2024-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) ## Size and sites **Participants** 1,350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Planned participants** 1,350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Number of sites** 365 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Lead sponsor** 89bio, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) ## Identifiers **Registry ID** NCT06318169 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **ClinicalTrials.gov ID** NCT06318169 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) ## 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/NCT06318169) ## Outcomes ### Primary outcomes 1. Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52 Timeframe: Week 52 Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis 2. Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52 Timeframe: Week 52 Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage. 3. Time to First Occurrence of Disease Progression Timeframe: Up to 5 years Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events ### Secondary outcomes 1. Percent Change from Baseline in Alanine Aminotransferase at Week 52 Timeframe: Baseline, Week 52 2. Absolute Change From Baseline in Enhanced Liver Fibrosis (ELF) Score at Week 52 Timeframe: Baseline, Week 52 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No Key Inclusion Criteria: - Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF) - Biopsy-confirmed MASH with fibrosis stage F2 or F3 - Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m^2) (≥23 kg/m^2 for Asian participants). Key Exclusion Criteria: - Chronic liver diseases other than MASH - Evidence of cirrhosis on screening liver biopsy - Have type 1 diabetes or poorly controlled type 2 diabetes - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L) - Participants taking vitamin E (>400 international units \[IU\]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening Other inclusion and exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) ## Sites - 89bio Clinical Study SiteBirmingham, United StatesRecruiting - 89bio Clinical Study SiteChandler, United StatesRecruiting - 89bio Clinical Study SiteFlagstaff, United StatesActive, not recruiting - 89bio Clinical Study SiteGlendale, United StatesRecruiting - 89bio Clinical Study SiteSun City, United StatesRecruiting - 89bio Clinical Study SiteTucson, United StatesRecruiting - 89bio Clinical Study SiteTucson, United StatesRecruiting - 89bio Clinical Study SiteConway, United StatesActive, not recruiting - 89bio Clinical Study SiteLittle Rock, United StatesRecruiting - 89bio Clinical Study SiteNorth Little Rock, United StatesRecruiting - 89bio Clinical Study SiteCanoga Park, United StatesRecruiting - 89bio Clinical Study SiteCoronado, United StatesRecruiting - 89bio Clinical Study SiteEscondido, United StatesRecruiting - 89bio Clinical Study SiteFountain Valley, United StatesRecruiting - 89bio Clinical Study SiteFresno, United StatesRecruiting - 89bio Clinical Study SiteGardena, United StatesRecruiting - 89bio Clinical Study SiteHuntington Park, United StatesWithdrawn - 89bio Clinical Study SiteInglewood, United StatesRecruiting - 89bio Clinical Study SiteLa Jolla, United StatesRecruiting - 89bio Clinical Study SiteLancaster, United StatesRecruiting - 89bio Clinical Study SiteLong Beach, United StatesRecruiting - 89bio Clinical Study SiteLos Angeles, United StatesRecruiting - 89bio Clinical Study SiteMontclair, United StatesRecruiting - 89bio Clinical Study SiteOrange, United StatesRecruiting - 89bio Clinical Study SitePanorama City, United StatesWithdrawn And 340 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06318169) ## Related records ### Drugs (1) - [Pegozafermin](https://trialight.com/data/asset/pegozafermin-0c0a8418-4357-41d5-9265-d58377f558b8.md) ### Lead sponsors (1) - [89bio, Inc.](https://trialight.com/data/company/89bio-inc-fbc04c82-4f04-42f9-bf88-b8f681c64fb6.md) ### Conditions (3) - [Digestive system disorder](https://trialight.com/data/condition/digestive-system-disorder-ae55641c-32fa-5aa9-ab90-29f763a95dc0.md) - [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) - [Metabolic dysfunction-associated steatotic liver disease](https://trialight.com/data/condition/metabolic-dysfunction-associated-steatotic-liver-disease-beb92cb4-74bc-5e17-96f1-97aeed54ab35.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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