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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04048135
Recruitment Status : Completed
First Posted : August 7, 2019
Last Update Posted : November 30, 2022
Sponsor:
Collaborator:
ProSciento, Inc.
Information provided by (Responsible Party):
89bio, Inc.

Study Description
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Brief Summary:

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)


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Cohorts 1-6 is blinded, Cohort 7 is open label
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
Actual Primary Completion Date : August 28, 2020
Actual Study Completion Date : January 19, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
Experimental: Dose 4 Open Label Drug: BIO89-100
Subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Part 1-16 weeks, Part 2-23 weeks ]
  2. Number of subjects who discontinued due to AEs and due to related AEs [ Time Frame: Part 1 only-16 weeks ]
  3. To characterize the BIO89-100 Pharmacokinetics (PK) by Peak Plasma Concentration [ Time Frame: Part 1 only-13 weeks ]
  4. To characterize the BIO89-100 PK by Time to Peak Plasma Concentration (Tmax) [ Time Frame: Part 1 only-13 weeks ]
  5. To characterize the BIO89-100 PK by Area under the plasma concentration versus time curve (AUC) [ Time Frame: Part 1 only-13 weeks ]
  6. To characterize the BIO89-100 PK by the terminal elimination half-life (t1/2) [ Time Frame: Part 1 only-13 weeks ]
  7. To characterize effect of BIO89-100 on liver histology by Improvement in NAS score [ Time Frame: Part 2 only-20 weeks ]
    At least a 2-point improvement in NAFLD Activity Score (NAS) with at least a 1 point improvement in ballooning or lobular inflammation, and no worsening of fibrosis


Secondary Outcome Measures :
  1. Percentage change from baseline in Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) [ Time Frame: Part 1-13 weeks, Part 2-20 weeks ]
  2. Percentage change from baseline in triglycerides [ Time Frame: Part 1-13 weeks, Part 2-20 weeks ]
  3. Percentage change from baseline in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: Part 1-13 weeks, Part 2-20 weeks ]
  4. Percentage change from baseline in Alanine Transaminase (ALT) [ Time Frame: Part 1-13 weeks, Part 2-20 weeks ]
  5. Percentage change from baseline in N-terminal type III collagen propeptide (Pro-C3) [ Time Frame: Part 1-13 weeks, Part 2-20 weeks ]
  6. Assessment of the incidence and characteristics of anti drug antibodies (ADA) developed against BIO89-100 after dosing [ Time Frame: Part 1-16 week, Part 2-24 weeks ]
  7. To characterize effect of BIO89-100 on liver histology by improvement of fibrosis [ Time Frame: Part 2 only-20 weeks ]
    Improvement of fibrosis ≥1 stage without worsening of NASH

  8. To characterize effect of BIO89-100 on liver histology by NASH resolution [ Time Frame: Part 2 only-20 weeks ]
    NASH resolution without worsening of fibrosis


Eligibility Criteria
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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.
  • 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
Contacts and Locations
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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


Locations
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United States, Alabama
89bio Clinical Study Site
Madison, Alabama, United States, 35758
United States, Arizona
89bio Clinical Study Site
Chandler, Arizona, United States, 85224
89bio Clinical Study Site
Tucson, Arizona, United States, 85712
United States, California
89bio Clinical Study Site
Chula Vista, California, United States, 91911
89bio Clinical Study Site
Huntington Beach, California, United States, 92647
89bio Clinical Study Site
Montclair, California, United States, 91763
United States, Florida
89bio Clinical Study Site
Miami Lakes, Florida, United States, 33014
89bio Clinical Study Site
Miami, Florida, United States, 33014-3616
89bio Clinical Study Site
Ocala, Florida, United States, 34471
89bio Clinical Study Site
Sarasota, Florida, United States, 34240
United States, Louisiana
89bio Clinical Study Site
Lake Charles, Louisiana, United States, 70601
United States, New Jersey
89bio Clinical Study Site
Berlin, New Jersey, United States, 08009
89bio Clinical Study Site
Florham Park, New Jersey, United States, 07932
United States, New York
89bio Clinical Study Site
East Syracuse, New York, United States, 13057
United States, North Carolina
89bio Clinical Study Site
Concord, North Carolina, United States, 28027
89bio Clinical Study Site
Raleigh, North Carolina, United States, 27612
United States, South Carolina
89bio Clinical Study Site
Greenwood, South Carolina, United States, 29646
89bio Clinical Study Site
Summerville, South Carolina, United States, 29485
United States, Tennessee
89bio Clinical Study Site
Hermitage, Tennessee, United States, 37076
United States, Texas
89bio Clinical Study Site
Austin, Texas, United States, 78757
89bio Clinical Study Site
Edinburg, Texas, United States, 78539
89bio Clinical Study Site
Houston, Texas, United States, 77058
89bio Clinical Study Site
San Antonio, Texas, United States, 78215
89bio Clinical Study Site
San Antonio, Texas, United States, 78229
89bio Clinical Study Site
Wichita Falls, Texas, United States, 76301
Puerto Rico
89bio Clinical Study Site
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
89bio, Inc.
ProSciento, Inc.
Investigators
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Study Director: Charlton, MD 89bio, Inc.
More Information
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Responsible Party: 89bio, Inc.
ClinicalTrials.gov Identifier: NCT04048135    
Other Study ID Numbers: BIO89-100-002
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: November 30, 2022
Last Verified: November 2022
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, Inc.:
NASH, NAFLD
Liver diseases
Fatty Liver
Metabolic diseases
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Digestive System Diseases