Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
89bio, Inc.
With
ProSciento, Inc.
Age
21–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
