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

NCT06419374

RecruitingPhase 3

Sponsor: 89bio, Inc.

Conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Interventions: Pegozafermin, Placebo

Countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, France

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 \[previously known as nonalcoholic steatohepatitis, NASH\]).

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (321)
  • Birmingham, Alabama, United States
  • Homewood, Alabama, United States
  • Chandler, Arizona, United States
  • Flagstaff, Arizona, United States
  • Peoria, Arizona, United States
  • Phoenix, Arizona, United States
  • Sun City, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • North Little Rock, Arkansas, United States
  • Camarillo, California, United States
  • Canoga Park, California, United States
  • Coronado, California, United States
  • Fountain Valley, California, United States
  • Fresno, California, United States
  • Huntington Park, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Pasadena, California, United States
  • Poway, California, United States
  • Redwood City, California, United States
  • Rialto, California, United States
  • Sacramento, California, United States
  • Santa Ana, California, United States
  • Littleton, Colorado, United States
  • Clermont, Florida, United States
  • Fort Myers, Florida, United States
  • + 291 more on CT.gov