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A Multiple Ascending Dose Study of BIO89-100 in Subjects With Biopsy Confirmed NASH or NAFLD and at High Risk of NASH

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ClinicalTrials.gov Identifier: NCT04048135
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
ProSciento, Inc.
Information provided by (Responsible Party):
89bio Ltd.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
NASH Drug: BIO89-100 Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 29, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Dose 1 Drug: BIO89-100
Subcutaneous injection

Experimental: Dose 2 Drug: BIO89-100
Subcutaneous injection

Experimental: Dose 3 Drug: BIO89-100
Subcutaneous injection

Experimental: Dose 4 Drug: BIO89-100
Subcutaneous injection

Experimental: Dose 5 Drug: BIO89-100
Subcutaneous injection

Experimental: Dose 6 Drug: BIO89-100
Subcutaneous injection

Placebo Comparator: Placebo Other: Placebo
Subcutaneous injection




Primary Outcome Measures :
  1. Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 16 weeks ]
  2. Number of subjects who discontinued due to AEs and due to related AEs [ Time Frame: 16 weeks ]
  3. To characterize the BIO89-100 Pharmacokinetics (PK) by Peak Plasma Concentration [ Time Frame: 13 weeks ]
  4. To characterize the BIO89-100 PK by Time to Peak Plasma Concentration (Tmax) [ Time Frame: 13 weeks ]
  5. To characterize the BIO89-100 PK by Area under the plasma concentration versus time curve (AUC) [ Time Frame: 13 weeks ]
  6. To characterize the BIO89-100 PK by the terminal elimination half-life (t1/2) [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. Percentage change from baseline in Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) [ Time Frame: 13 weeks ]
  2. Percentage change from baseline in triglycerides [ Time Frame: 13 weeks ]
  3. Percentage change from baseline in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: 13 weeks ]
  4. Percentage change from baseline in Alanine Transaminase (ALT) [ Time Frame: 13 weeks ]
  5. Percentage change from baseline in N-terminal type III collagen propeptide (Pro-C3) [ Time Frame: 13 weeks ]
  6. Assessment of the incidence and characteristics of anti drug antibodies (ADA) developed against BIO89-100 after dosing [ Time Frame: 16 weeks ]


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048135


Contacts
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Contact: 89bio Medical Director +972-9-373-1799 ext 5 bio89-100-002@89bio.com

Locations
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United States, California
89bio Clinical Study Site Recruiting
Chula Vista, California, United States, 91911
Contact: 89bio site 101         
United States, New Jersey
89bio Clinical Study Site Recruiting
Berlin, New Jersey, United States, 08009
Contact: 89bio site 102         
Sponsors and Collaborators
89bio Ltd.
ProSciento, Inc.
Investigators
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Study Director: Mansbach, MD 89bio Ltd.

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Responsible Party: 89bio Ltd.
ClinicalTrials.gov Identifier: NCT04048135     History of Changes
Other Study ID Numbers: BIO89-100-002
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 89bio Ltd.:
NASH, NAFLD
Liver diseases
Fatty Liver
Metabolic diseases
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Digestive System Diseases