A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Recruiting · NCT06419374 · Interventional (participants receive a specific treatment) · Lead sponsor: 89bio, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
PegozaferminPlacebo
What this trial is about
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 can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
- ther protocol-defined inclusion and exclusion criteria may apply.
Where it is running
60 locations listed across 34 US states.
- 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 - Sun City, 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
- 89bio Clinical Study Site - Pasadena, California, United States
- 89bio Clinical Study Site - Poway, California, United States
- 89bio Clinical Study Site - Redwood City, California, United States
- 89bio Clinical Study Site - Rialto, California, United States
- 89bio Clinical Study Site - Sacramento, California, United States
- 89bio Clinical Study Site - Santa Ana, California, United States
- 89bio Clinical Study Site - Littleton, Colorado, United States
- 89bio Clinical Study Site - Clermont, Florida, United States
- 89bio Clinical Study Site - Fort Myers, Florida, United States
- 89bio Clinical Study Site - Gainesville, Florida, United States
- 89bio Clinical Study Site - Hialeah Gardens, Florida, United States
- 89bio Clinical Study Site - Homestead, Florida, United States
- 89bio Clinical Study Site - Jacksonville, Florida, United States
- 89bio Clinical Study Site - Jacksonville, Florida, United States
- 89bio Clinical Study Site - Lady Lake, Florida, United States
- 89bio Clinical Study Site - Lakewood Rch, Florida, United States
- 89bio Clinical Study Site - Lehigh Acres, Florida, United States
- 89bio Clinical Study Site - Maitland, Florida, United States
- 89bio Clinical Study Site - Miami, Florida, United States
- 89bio Clinical Study Site - Miami, Florida, United States
- 89bio Clinical Study Site - Miami, Florida, United States
- 89bio Clinical Study Site - Miami, Florida, United States
- 89bio Clinical Study Site - New Port Richey, Florida, United States
- 89bio Clinical Study Site - Ocala, Florida, United States
- 89bio Clinical Study Site - Ocoee, Florida, United States
- 89bio Clinical Study Site - Orlando, Florida, United States
- 89bio Clinical Study Site - University Park, Florida, United States
- 89bio Clinical Study Site - Viera, Florida, United States
- 89bio Clinical Study Site - Winter Park, Florida, United States
- 89bio Clinical Study Site - Athens, Georgia, United States
- 89bio Clinical Study Site - Atlanta, Georgia, United States
- 89bio Clinical Study Site - Chicago, Illinois, United States
- 89bio Clinical Study Site - Glenview, Illinois, United States
- 89bio Clinical Study Site - Hammond, Indiana, United States
- 89bio Clinical Study Site - New Albany, Indiana, United States
- 89bio Clinical Study Site - South Bend, Indiana, United States
- 89bio Clinical Study Site - Iowa City, Iowa, United States
- 89bio Clinical Study Site - Kansas City, Kansas, United States
- 89bio Clinical Study Site - Topeka, Kansas, United States
Showing 60 of 326 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →