RECRUITINGPhase 3INTERVENTIONAL
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
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)
About This Trial
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).
Who May Be Eligible (Plain English)
Key Who May Qualify:
- Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the willing to sign a consent form 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 Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
* 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.
Treatments Being Tested
BIOLOGICAL
Pegozafermin
Subcutaneous injection
DRUG
Placebo
Subcutaneous injection
Locations (20)
89bio Clinical Study Site
Birmingham, Alabama, United States
89bio Clinical Study Site
Homewood, Alabama, United States
89bio Clinical Study Site
Chandler, Arizona, United States
89bio Clinical Study Site
Flagstaff, Arizona, United States
89bio Clinical Study Site
Peoria, Arizona, United States
89bio Clinical Study Site
Phoenix, Arizona, United States
89bio Clinical Study Site
Tucson, Arizona, United States
89bio Clinical Study Site
Tucson, Arizona, United States
89bio Clinical Study Site
Tucson, Arizona, United States
89bio Clinical Study Site
Little Rock, Arkansas, United States
89bio Clinical Study Site
North Little Rock, Arkansas, United States
89bio Clinical Study Site
Camarillo, California, United States
89bio Clinical Study Site
Canoga Park, California, United States
89bio Clinical Study Site
Coronado, California, United States
89bio Clinical Study Site
Fountain Valley, California, United States
89bio Clinical Study Site
Fresno, California, United States
89bio Clinical Study Site
Huntington Park, California, United States
89bio Clinical Study Site
La Jolla, California, United States
89bio Clinical Study Site
Los Angeles, California, United States
89bio Clinical Study Site
Los Angeles, California, United States