A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: NASH
In brief
Part 1: This is a multi-center evaluation of pegozafermin (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in participants with NASH and NAFLD at high risk of NASH, including a pre-defined number of participants with biopsy confirmed NASH and fibrosis stages F1-F3 to be enrolled. Part 2: This is a multi-center, open label evaluation of pegozafermin at 27 mg administered weekly for 20 weeks in participants with biopsy-proven NASH (NAS ≥4, fibrosis stage F2 or F3).
Key facts
- Study ID
- NCT04048135
- Run by
- 89bio, Inc.
- People needed
- 101
- Starts
- 2019-07-29
- Expected to finish
- 2022-01-19
- Last updated by the study team
- 2024-04-02
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 89bio Clinical Study Site — Madison, Alabama, United States
- 89bio Clinical Study Site — Chandler, Arizona, United States
- 89bio Clinical Study Site — Tucson, Arizona, United States
- 89bio Clinical Study Site — Chula Vista, California, United States
- 89bio Clinical Study Site — Huntington Beach, California, United States
- 89bio Clinical Study Site — Montclair, California, United States
- 89bio Clinical Study Site — Miami, Florida, United States
- 89bio Clinical Study Site — Miami Lakes, Florida, United States
- 89bio Clinical Study Site — Ocala, Florida, United States
- 89bio Clinical Study Site — Sarasota, Florida, United States
- 89bio Clinical Study Site — Lake Charles, Louisiana, United States
- 89bio Clinical Study Site — Berlin, New Jersey, United States
- 89bio Clinical Study Site — Florham Park, New Jersey, United States
- 89bio Clinical Study Site — East Syracuse, New York, United States
- 89bio Clinical Study Site — Concord, North Carolina, United States
- 89bio Clinical Study Site — Raleigh, North Carolina, United States
- 89bio Clinical Study Site — Greenwood, South Carolina, United States
- 89bio Clinical Study Site — Summerville, South Carolina, United States
- 89bio Clinical Study Site — Hermitage, Tennessee, United States
- 89bio Clinical Study Site — Austin, Texas, United States
- 89bio Clinical Study Site — Edinburg, Texas, United States
- 89bio Clinical Study Site — Houston, Texas, United States
- 89bio Clinical Study Site — San Antonio, Texas, United States
- 89bio Clinical Study Site — San Antonio, Texas, United States
- 89bio Clinical Study Site — Wichita Falls, Texas, United States
Full record on ClinicalTrials.gov
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