Status:
COMPLETED
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
Lead Sponsor:
89bio, Inc.
Collaborating Sponsors:
ProSciento, Inc.
Conditions:
NASH
Eligibility:
All Genders
21-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 wi...
Eligibility Criteria
Inclusion
- Key
- Participants must be 21 to 75 years of age inclusive, at the time of signing the informed consent form (ICF).
- Evidence of steatosis by Fibroscan and magnetic resonance imaging based proton density fat fraction (MRI-PDFF)
- NASH or NAFLD at high risk for NASH as reflected by AT LEAST ONE of the following:
- Diagnosis of NASH with fibrosis (stages F1, F2 or F3), without cirrhosis, by percutaneous liver biopsy within 24 months prior to screening
- Central obesity WITH type 2 diabetes mellitus (T2DM)
- Central obesity WITH either increased alanine transaminase (ALT) and/or Fibroscan vibration-controlled transient elastography (VCTE) score ≥7 KPa.
- Part 2 only: Biopsy-proven NASH in a liver biopsy obtained within 24 weeks of baseline with fibrosis stage F2 or F3 and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation. A small number of high risk F1 allowed.
- Key
Exclusion
- Clinically significant disorder or a history of any illness that, in the opinion of the Investigator, might confound the results of the study, or pose additional risk to the participant by participation in the study.
- History of type 1 diabetes.
- Weight loss of more than 5% within 3 months prior to Day -1 or more than 10% within 6 months prior to Day -1 or planning to try to lose weight during conduct of study.
- History of a liver disorder other than NASH or clinical suspicion of a liver disorder other than NASH
- History of cirrhosis or evidence of cirrhosis
Key Trial Info
Start Date :
July 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2022
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04048135
Start Date
July 29 2019
End Date
January 19 2022
Last Update
April 2 2024
Active Locations (26)
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1
89bio Clinical Study Site
Madison, Alabama, United States, 35758
2
89bio Clinical Study Site
Chandler, Arizona, United States, 85224
3
89bio Clinical Study Site
Tucson, Arizona, United States, 85712
4
89bio Clinical Study Site
Chula Vista, California, United States, 91911