A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Recruiting · NCT06318169 · 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 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
Who can take part
Age range
18 Years to 80 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 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
- ther inclusion and exclusion criteria may apply.
Where it is running
60 locations listed across 32 US states.
- 89bio Clinical Study Site - Birmingham, Alabama, United States
- 89bio Clinical Study Site - Chandler, Arizona, United States
- 89bio Clinical Study Site - Flagstaff, Arizona, United States
- 89bio Clinical Study Site - Glendale, 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 - Conway, Arkansas, 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 - Canoga Park, California, United States
- 89bio Clinical Study Site - Coronado, California, United States
- 89bio Clinical Study Site - Escondido, California, United States
- 89bio Clinical Study Site - Fountain Valley, California, United States
- 89bio Clinical Study Site - Fresno, California, United States
- 89bio Clinical Study Site - Gardena, California, United States
- 89bio Clinical Study Site - Huntington Park, California, United States
- 89bio Clinical Study Site - Inglewood, California, United States
- 89bio Clinical Study Site - La Jolla, California, United States
- 89bio Clinical Study Site - Lancaster, California, United States
- 89bio Clinical Study Site - Long Beach, California, United States
- 89bio Clinical Study Site - Los Angeles, California, United States
- 89bio Clinical Study Site - Montclair, California, United States
- 89bio Clinical Study Site - Orange, California, United States
- 89bio Clinical Study Site - Panorama City, California, United States
- 89bio Clinical Study Site - Pasadena, California, United States
- 89bio Clinical Study Site - Poway, California, United States
- 89bio Clinical Study Site - Rialto, California, United States
- 89bio Clinical Study Site - Santa Ana, California, United States
- 89bio Clinical Study Site - Stanford, California, United States
- 89bio Clinical Study Site - Victorville, California, United States
- 89bio Clinical Study Site - Colorado Springs, Colorado, United States
- 89bio Clinical Study Site - Littleton, Colorado, United States
- 89bio Clinical Study Site - Brandon, Florida, United States
- 89bio Clinical Study Site - Clermont, Florida, United States
- 89bio Clinical Study Site - Fort Myers, 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 - Jupiter, Florida, United States
- 89bio Clinical Study Site - Lady Lake, 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 - Maitland, 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 - Sarasota, Florida, United States
- 89bio Clinical Study Site - Winter Park, Florida, United States
- 89bio Clinical Study Site - Athens, Georgia, United States
- 89bio Clinical Study Site - Dalton, Georgia, United States
- 89bio Clinical Study Site - Marietta, Georgia, United States
- 89bio Clinical Study Site - Chicago, 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
Showing 60 of 367 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →