A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

Recruitment Status: RECRUITING
(See Contacts and Locations)Verified May 2026 by 89bio, Inc.
Sponsor: 89bio, Inc.
Information Provided by (Responsible Party): 89bio, Inc.

Clinicaltrials.gov Identifier: NCT06419374
Other Study ID Numbers:: BIO89-100-132

First Submitted: May 13, 2024
First Posted: May 16, 2024
Last Update Posted: June 3, 2026
Last Verified: May 2026

ClinicalTrials.gov processed this data on June 2026. Link to the current ClinicalTrials.gov record .

Study Details

Study Description

Condition or Disease	Intervention/Treatment
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis	Biological: PegozaferminDrug: Placebo

Study Design

Study Type	Interventional
Actual Enrollment	762 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Quadruple
Primary Purpose	Treatment
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)
Study Start Date	May 23, 2024
Actual Primary Completion Date	1yr 11mos from now
Actual Study Completion Date	5yrs 1mo from now

Groups and Cohorts

Group/Cohort	Intervention/Treatment
Pegozafermin	Biological: Pegozafermin Subcutaneous injection
Placebo Matched placebo	Drug: Placebo Subcutaneous injection

Outcome Measures

Primary Outcome Measures

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 to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events

Secondary Outcome Measures

Change from Baseline in Enhanced Liver Fibrosis (ELF) Score
Change from Baseline in Alanine Aminotransferase (ALT) Level
Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE)
Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH)

Eligibility Criteria

Ages Eligible for Study	(Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
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. Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis. Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2). 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.

Contacts and Locations

Sponsors and Collaborators	89bio, Inc.
Locations	89bio Clinical Study Site \| Birmingham Alabama, United States, 3520589bio Clinical Study Site \| Homewood Alabama, United States, 3520989bio Clinical Study Site \| Chandler Arizona, United States, 8522489bio Clinical Study Site \| Flagstaff Arizona, United States, 8600189bio Clinical Study Site \| Peoria Arizona, United States, 8538189bio Clinical Study Site \| Phoenix Arizona, United States, 8505489bio Clinical Study Site \| Tucson Arizona, United States, 8571289bio Clinical Study Site \| Tucson Arizona, United States, 8571589bio Clinical Study Site \| Tucson Arizona, United States, 8571689bio Clinical Study Site \| Little Rock Arkansas, United States, 7220589bio Clinical Study Site \| North Little Rock Arkansas, United States, 7211789bio Clinical Study Site \| Camarillo California, United States, 9301289bio Clinical Study Site \| Canoga Park California, United States, 9130489bio Clinical Study Site \| Coronado California, United States, 9211889bio Clinical Study Site \| Fountain Valley California, United States, 9270889bio Clinical Study Site \| Fresno California, United States, 9372089bio Clinical Study Site \| Huntington Park California, United States, 9025589bio Clinical Study Site \| La Jolla California, United States, 92037-088789bio Clinical Study Site \| Los Angeles California, United States, 9003389bio Clinical Study Site \| Los Angeles California, United States, 9004889bio Clinical Study Site \| Pasadena California, United States, 9110589bio Clinical Study Site \| Poway California, United States, 9206489bio Clinical Study Site \| Redwood City California, United States, 9406389bio Clinical Study Site \| Rialto California, United States, 9237789bio Clinical Study Site \| Sacramento California, United States, 9581789bio Clinical Study Site \| Santa Ana California, United States, 9270489bio Clinical Study Site \| Littleton Colorado, United States, 8012089bio Clinical Study Site \| Clermont Florida, United States, 3471189bio Clinical Study Site \| Fort Myers Florida, United States, 3391289bio Clinical Study Site \| Gainesville Florida, United States, 3261089bio Clinical Study Site \| Hialeah Gardens Florida, United States, 3301689bio Clinical Study Site \| Homestead Florida, United States, 3303089bio Clinical Study Site \| Jacksonville Florida, United States, 3222489bio Clinical Study Site \| Jacksonville Florida, United States, 3225689bio Clinical Study Site \| Lady Lake Florida, United States, 3215989bio Clinical Study Site \| Lakewood Rch Florida, United States, 3421189bio Clinical Study Site \| Lehigh Acres Florida, United States, 3393689bio Clinical Study Site \| Maitland Florida, United States, 3275189bio Clinical Study Site \| Miami Florida, United States, 3314489bio Clinical Study Site \| Miami Florida, United States, 33176-153089bio Clinical Study Site \| Miami Florida, United States, 33176-794789bio Clinical Study Site \| New Port Richey Florida, United States, 3465389bio Clinical Study Site \| Ocala Florida, United States, 3447189bio Clinical Study Site \| Ocoee Florida, United States, 3476189bio Clinical Study Site \| Orlando Florida, United States, 3282589bio Clinical Study Site \| University Park Florida, United States, 3420189bio Clinical Study Site \| Viera Florida, United States, 3294089bio Clinical Study Site \| Winter Park Florida, United States, 3278989bio Clinical Study Site \| Athens Georgia, United States, 3060789bio Clinical Study Site \| Atlanta Georgia, United States, 3030989bio Clinical Study Site \| Chicago Illinois, United States, 6061189bio Clinical Study Site \| Hammond Indiana, United States, 4632489bio Clinical Study Site \| New Albany Indiana, United States, 4715089bio Clinical Study Site \| South Bend Indiana, United States, 4663589bio Clinical Study Site \| Iowa City Iowa, United States, 5224289bio Clinical Study Site \| Kansas City Kansas, United States, 6616089bio Clinical Study Site \| Topeka Kansas, United States, 6660689bio Clinical Study Site \| Lafayette Louisiana, United States, 7050389bio Clinical Study Site \| Lake Charles Louisiana, United States, 7060589bio Clinical Study Site \| West Monroe Louisiana, United States, 7129189bio Clinical Study Site \| Baltimore Maryland, United States, 2120289bio Clinical Study Site \| Glen Burnie Maryland, United States, 2106189bio Clinical Study Site \| Greenbelt Maryland, United States, 2077089bio Clinical Study Site \| Burlington Massachusetts, United States, 0180589bio Clinical Study Site \| Ann Arbor Michigan, United States, 4810989bio Clinical Study Site \| Clinton Township Michigan, United States, 4803889bio Clinical Study Site \| Detroit Michigan, United States, 4820289bio Clinical Study Site \| Wyoming Michigan, United States, 4951989bio Clinical Study Site \| Ypsilanti Michigan, United States, 4819789bio Clinical Study Site \| Minneapolis Minnesota, United States, 5541389bio Clinical Study Site \| Rochester Minnesota, United States, 5590589bio Clinical Study Site \| Flowood Mississippi, United States, 3923289bio Clinical Study Site \| Tupelo Mississippi, United States, 3880189bio Clinical Study Site \| St Louis Missouri, United States, 6311089bio Clinical Study Site \| St Louis Missouri, United States, 6312389bio Clinical Study Site \| Las Vegas Nevada, United States, 8910689bio Clinical Study Site \| Florham Park New Jersey, United States, 0793289bio Clinical Study Site \| Somers Point New Jersey, United States, 0824489bio Clinical Study Site \| Albuquerque New Mexico, United States, 8710989bio Clinical Study Site \| New York New York, United States, 1001689bio Clinical Study Site \| New York New York, United States, 1002189bio Clinical Study Site \| New York New York, United States, 1003389bio Clinical Study Site \| Asheville North Carolina, United States, 2880189bio Clinical Study Site \| Charlotte North Carolina, United States, 2820789bio Clinical Study Site \| Durham North Carolina, United States, 2771089bio Clinical Study Site \| Fayetteville North Carolina, United States, 2830489bio Clinical Study Site \| Greenville North Carolina, United States, 2783489bio Clinical Study Site \| Winston-Salem North Carolina, United States, 2710389bio Clinical Study Site \| Akron Ohio, United States, 4432089bio Clinical Study Site \| Cincinnati Ohio, United States, 4526789bio Clinical Study Site \| Cleveland Ohio, United States, 4410689bio Clinical Study Site \| Columbus Ohio, United States, 4321089bio Clinical Study Site \| Dayton Ohio, United States, 4541489bio Clinical Study Site \| Liberty Township Ohio, United States, 4504489bio Clinical Study Site \| Westlake Ohio, United States, 4414589bio Clinical Study Site \| Philadelphia Pennsylvania, United States, 1914889bio Clinical Study Site \| Pittsburgh Pennsylvania, United States, 1521389bio Clinical Study Site \| East Greenwich Rhode Island, United States, 0281889bio Clinical Study Site \| Charleston South Carolina, United States, 2942589bio Clinical Study Site \| Columbia South Carolina, United States, 2920489bio Clinical Study Site \| Rapid City South Dakota, United States, 5770189bio Clinical Study Site \| Cordova Tennessee, United States, 3801889bio Clinical Study Site \| Hermitage Tennessee, United States, 3707689bio Clinical Study Site \| Nashville Tennessee, United States, 3721189bio Clinical Study Site \| Amarillo Texas, United States, 7910689bio Clinical Study Site \| Austin Texas, United States, 7874589bio Clinical Study Site \| Austin Texas, United States, 78757-805989bio Clinical Study Site \| Austin Texas, United States, 78757-806689bio Clinical Study Site \| Brownsville Texas, United States, 7852089bio Clinical Study Site \| DeSoto Texas, United States, 7511589bio Clinical Study Site \| Edinburg Texas, United States, 7853989bio Clinical Study Site \| Farmers Branch Texas, United States, 7523489bio Clinical Study Site \| Fort Worth Texas, United States, 7610489bio Clinical Study Site \| Harlingen Texas, United States, 7855089bio Clinical Study Site \| Houston Texas, United States, 7703089bio Clinical Study Site \| Houston Texas, United States, 7707489bio Clinical Study Site \| Houston Texas, United States, 7709989bio Clinical Study Site \| Lewisville Texas, United States, 7506789bio Clinical Study Site \| Lubbock Texas, United States, 7941089bio Clinical Study Site \| Mansfield Texas, United States, 7606389bio Clinical Study Site \| Pearland Texas, United States, 7758489bio Clinical Study Site \| San Antonio Texas, United States, 7820989bio Clinical Study Site \| San Antonio Texas, United States, 78229-480189bio Clinical Study Site \| San Antonio Texas, United States, 78229-506989bio Clinical Study Site \| San Marcos Texas, United States, 7866689bio Clinical Study Site \| Waco Texas, United States, 7671089bio Clinical Study Site \| Waco Texas, United States, 7671289bio Clinical Study Site \| Sandy City Utah, United States, 8409289bio Clinical Study Site \| West Jordan Utah, United States, 8408889bio Clinical Study Site \| Richmond Virginia, United States, 2322689bio Clinical Study Site \| Richmond Virginia, United States, 2322989bio Clinical Study Site \| Richmond Virginia, United States, 2323689bio Clinical Study Site \| Richmond Virginia, United States, 2329889bio Clinical Study Site \| Seattle Washington, United States, 9810189bio Clinical Study Site \| Seattle Washington, United States, 9810589bio Clinical Study Site \| Buenos Aires , Argentina, C1012AAR89bio Clinical Study Site \| Buenos Aires , Argentina, C1125ABE89bio Clinical Study Site \| Buenos Aires , Argentina, C1199ABB89bio Clinical Study Site \| Buenos Aires , Argentina, C1425BGH89bio Clinical Study Site \| Buenos Aires , Argentina, C142589bio Clinical Study Site \| Buenos Aires , Argentina, CP 106189bio Clinical Study Site \| CABA , Argentina, C1430CKE89bio Clinical Study Site \| Capital Federal , Argentina, C1280AEB89bio Clinical Study Site \| Pilar , Argentina, B1629AHJ89bio Clinical Study Site \| Adelaide , Australia, SA 500089bio Clinical Study Site \| Fitzroy , Australia, 0306589bio Clinical Study Site \| Greenslopes , Australia, 0412089bio Clinical Study Site \| Heidelberg , Australia, 308489bio Clinical Study Site \| Herston , Australia, Qld 402989bio Clinical Study Site \| Murdoch , Australia, 0615089bio Clinical Study Site \| Perth , Australia, 0600089bio Clinical Study Site \| South Brisbane , Australia, 0410189bio Clinical Study Site \| Brussels , Belgium, 0107089bio Clinical Study Site \| Brussels , Belgium, 0109089bio Clinical Study Site \| Brussels , Belgium, 120089bio Clinical Study Site \| Edegem , Belgium, 0265089bio Clinical Study Site \| Genk , Belgium, 0360089bio Clinical Study Site \| Ghent , Belgium, 0900089bio Clinical Study Site \| Roeselare , Belgium, 0880089bio Clinical Study Site \| Barretos , Brazil, 14784-40089bio Clinical Study Site \| Belo Horizonte , Brazil, 30220-14089bio Clinical Study Site \| Botucatu , Brazil, 18618-68789bio Clinical Study Site \| Goiânia , Brazil, 74605-05089bio Clinical Study Site \| Porto Alegre , Brazil, 90035-90389bio Clinical Study Site \| Rio de Janeiro , Brazil, 21941-61789bio Clinical Study Site \| Salvador , Brazil, 41820-46089bio Clinical Study Site \| São José do Rio Preto , Brazil, 15090-00089bio Clinical Study Site \| São Paulo , Brazil, 04038-00289bio Clinical Study Site \| Vitória , Brazil, 29055-45089bio Clinical Study Site \| Gorna Oryahovitsa , Bulgaria, 0510089bio Clinical Study Site \| Sofia , Bulgaria, 0120289bio Clinical Study Site \| Sofia , Bulgaria, 0140789bio Clinical Study Site \| Stara Zagora , Bulgaria, 0600389bio Clinical Study Site \| Calgary Alberta, Canada, T2N 4Z689bio Clinical Study Site \| Vancouver British Columbia, Canada, V5Z 1M989bio Clinical Study Site \| Vancouver British Columbia, Canada, V6Z2K589bio Clinical Study Site \| Winnipeg Manitoba, Canada, R3E 3P489bio Clinical Study Site \| London Ontario, Canada, N6A5A589bio Clinical Study Site \| Ottawa Ontario, Canada, K1H 8L689bio Clinical Study Site \| Toronto Ontario, Canada, M6H3M189bio Clinical Study Site \| Vaughan , Canada, L4L 4Y789bio Clinical Study Site \| Amiens , France, 8005489bio Clinical Study Site \| Dijon , France, 2100089bio Clinical Study Site \| Limoges , France, 8700089bio Clinical Study Site \| Lyon , France, 6900489bio Clinical Study Site \| Montpellier , France, 3429589bio Clinical Study Site \| Nice , France, 0620289bio Clinical Study Site \| Paris , France, 7501289bio Clinical Study Site \| Paris , France, 7501389bio Clinical Study Site \| Paris , France, 7501489bio Clinical Study Site \| Pessac , France, 3360489bio Clinical Study Site \| Strasbourg , France, 6709189bio Clinical Study Site \| Toulouse , France, 3140089bio Clinical Study Site \| Vandœuvre-lès-Nancy , France, 5450089bio Clinical Study Site \| Vénissieux , France, 6969489bio Clinical Study Site \| Villejuif , France, 9480089bio Clinical Study Site \| Chemnitz , Germany, 911689bio Clinical Study Site \| Frankfurt , Germany, 6059089bio Clinical Study Site \| Freiburg im Breisgau , Germany, 7911089bio Clinical Study Site \| Hanover , Germany, 3062589bio Clinical Study Site \| Homburg , Germany, 6642189bio Clinical Study Site \| Münster , Germany, 4814989bio Clinical Study Site \| Hong Kong , Hong Kong, 89bio Clinical Study Site \| Shatin , Hong Kong, 89bio Clinical Study Site \| Budapest , Hungary, 0102789bio Clinical Study Site \| Budapest , Hungary, 0108889bio Clinical Study Site \| Budapest , Hungary, H-109789bio Clinical Study Site \| Gujrāt , India, 36000189bio Clinical Study Site \| Sūrat , India, 39500989bio Clinical Study Site \| Afula , Israel, 183411189bio Clinical Study Site \| Beersheba , Israel, 841010189bio Clinical Study Site \| Haifa , Israel, 310960189bio Clinical Study Site \| Haifa , Israel, 343621289bio Clinical Study Site \| Jerusalem , Israel, 911200189bio Clinical Study Site \| Nahariya , Israel, 221000189bio Clinical Study Site \| Petah Tikva , Israel, 4910089bio Clinical Study Site \| Tel Aviv , Israel, 6971089bio Clinical Study Site \| Tel Litwinsky , Israel, 526560189bio Clinical Study Site \| Bergamo , Italy, 2412789bio Clinical Study Site \| Foggia , Italy, 7112189bio Clinical Study Site \| Milan , Italy, 2012289bio Clinical Study Site \| Milan , Italy, 2016289bio Clinical Study Site \| Novara , Italy, 2810089bio Clinical Study Site \| Palermo , Italy, 9012789bio Clinical Study Site \| Roma , Italy, 0012889bio Clinical Study Site \| Rome , Italy, 0016889bio Clinical Study Site \| Rozzano , Italy, 2008989bio Clinical Study Site \| Torino , Italy, 1012489bio Clinical Study Site \| Chihuahua City , Mexico, 3121789bio Clinical Study Site \| Cuautitlán Izcalli , Mexico, CP 5476989bio Clinical Study Site \| Cuernavaca , Mexico, 6225089bio Clinical Study Site \| Jalisco , Mexico, 4413089bio Clinical Study Site \| Mexico City , Mexico, 0333089bio Clinical Study Site \| Mexico City , Mexico, 0670089bio Clinical Study Site \| Mérida , Mexico, 9707089bio Clinical Study Site \| Monterrey , Mexico, 6431089bio Clinical Study Site \| Amsterdam , Netherlands, 1081 HV89bio Clinical Study Site \| Rotterdam , Netherlands, 3015GD89bio Clinical Study Site \| Tilburg , Netherlands, 5022 GC89bio Clinical Study Site \| Utrecht , Netherlands, 3584 CX89bio Clinical Study Site \| Katowice , Poland, 40-75289bio Clinical Study Site \| Krakow , Poland, 31-50189bio Clinical Study Site \| Lodz , Poland, 90-30289bio Clinical Study Site \| Lodz , Poland, 91-36389bio Clinical Study Site \| Mysłowice , Poland, 41-40089bio Clinical Study Site \| Warsaw , Poland, 00-21589bio Clinical Study Site \| Warsaw , Poland, 02-17289bio Clinical Study Site \| Warsaw , Poland, 04-50189bio Clinical Study Site \| Wroclaw , Poland, 53-67389bio Clinical Study Site \| Manati , Puerto Rico, 0067489bio Clinical Study Site \| Mayagüez , Puerto Rico, 0068089bio Clinical Study Site \| San Juan , Puerto Rico, 0092789bio Clinical Study Site \| Singapore , Singapore, 11907489bio Clinical Study Site \| Singapore , Singapore, 16960889bio Clinical Study Site \| Singapore , Singapore, 30843389bio Clinical Study Site \| Singapore , Singapore, 52988989bio Clinical Study Site \| Bucheon-si , South Korea, 1458489bio Clinical Study Site \| Busan , South Korea, 4924189bio Clinical Study Site \| Daegu , South Korea, 4241589bio Clinical Study Site \| Daegu , South Korea, 700-71289bio Clinical Study Site \| Incheon , South Korea, 2233289bio Clinical Study Site \| Seoul , South Korea, 0308089bio Clinical Study Site \| Seoul , South Korea, 0659189bio Clinical Study Site \| Seoul , South Korea, 0706189bio Clinical Study Site \| Seoul , South Korea, 0789589bio Clinical Study Site \| Seoul , South Korea, 130-87289bio Clinical Study Site \| Almería , Spain, 0400989bio Clinical Study Site \| Badalona , Spain, 0891689bio Clinical Study Site \| Barcelona , Spain, 0800389bio Clinical Study Site \| Barcelona , Spain, 0803589bio Clinical Study Site \| Barcelona , Spain, 0804189bio Clinical Study Site \| Córdoba , Spain, 1400489bio Clinical Study Site \| Madrid , Spain, 2800789bio Clinical Study Site \| Málaga , Spain, 2901089bio Clinical Study Site \| Pontevedra , Spain, 3607189bio Clinical Study Site \| Santander , Spain, 3900889bio Clinical Study Site \| Santiago de Compostela , Spain, 1570689bio Clinical Study Site \| Zaragoza , Spain, 5000989bio Clinical Study Site \| Chiayi City , Taiwan, 6000289bio Clinical Study Site \| Kaohsiung City , Taiwan, 8075689bio Clinical Study Site \| Tainan , Taiwan, 0070489bio Clinical Study Site \| Bornova İzmir, Turkey (Türkiye), 3504089bio Clinical Study Site \| Merkez Rize Province, Turkey (Türkiye), 5302089bio Clinical Study Site \| Ankara , Turkey (Türkiye), 0610089bio Clinical Study Site \| Ankara , Turkey (Türkiye), 680089bio Clinical Study Site \| Fatih , Turkey (Türkiye), 3409389bio Clinical Study Site \| Istanbul , Turkey (Türkiye), 3401089bio Clinical Study Site \| Istanbul , Turkey (Türkiye), 3472289bio Clinical Study Site \| Izmir , Turkey (Türkiye), 3536089bio Clinical Study Site \| Umraniye , Turkey (Türkiye), 3476489bio Clinical Study Site \| Yüreğir , Turkey (Türkiye), 137089bio Clinical Study Site \| Aberdeen , United Kingdom, AB25 2ZN89bio Clinical Study Site \| Bristol , United Kingdom, BS10 5NB89bio Clinical Study Site \| Leeds , United Kingdom, LS9 7TF89bio Clinical Study Site \| London , United Kingdom, E1 1BB89bio Clinical Study Site \| London , United Kingdom, NW3 2QG89bio Clinical Study Site \| London , United Kingdom, SE5 9RS89bio Clinical Study Site \| London , United Kingdom, W2 1NY89bio Clinical Study Site \| Oxford , United Kingdom, OX3 9DU89bio Clinical Study Site \| Plymouth , United Kingdom, PL6 8DH89bio Clinical Study Site \| Port Talbot , United Kingdom, SA12 7BR89bio Clinical Study Site \| Portsmouth , United Kingdom, P06 3LY89bio Clinical Study Site \| Southampton , United Kingdom, SO16 6YD
Investigators	Study Director: Maya Margalit, MD, 89bio, Inc.

More Information

Additional Relevant MeSH Terms

Non-alcoholic Fatty Liver DiseaseLiver DiseasesFatty LiverDigestive System DiseasesMetabolic DiseasesFibrosisNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms