Trial | NCT04048135  Report issue

Title

A Multiple Ascending Dose Study of BIO89-100 in Subjects With Biopsy Confirmed NASH or NAFLD and at High Risk of NASH
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of BIO89-100 Administered Subcutaneously in Subjects With Nonalcoholic Steatohepatitis (NASH) or With Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    NASH

  • Intervention/Treatment

    BIO89-100 ...

  • Study Participants

    101
Part 1: This is a multi-center evaluation of BIO89-100 (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in subjects with NASH and NAFLD at high risk of NASH, including a pre-defined number of subjects with biopsy confirmed NASH and fibrosis stages F1-F3 to be enrolled

Part 2: This is a multi-center, open label evaluation of BIO89-100 at 27 mg administered weekly for 20 weeks in subjects with biopsy-poven NASH (NAS ≥4, fibrosis stage F2 or F3)
Study Started
Jul 29
2019
Primary Completion
Aug 28
2020
Study Completion
Jan 19
2022
Last Update
Nov 30
2022

Drug BIO89-100

Subcutaneous injection

Other Placebo

Subcutaneous injection

Dose 1 Experimental

Dose 2 Experimental

Dose 3 Experimental

Dose 4 Experimental

Dose 5 Experimental

Dose 6 Experimental

Placebo Placebo Comparator

Dose 4 Open Label Experimental

Criteria 

Key Inclusion Criteria:

Subjects 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 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 T2DM
Central obesity WITH either increased ALT and/or Fibroscan 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 Criteria:

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 subject 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
No Results Posted