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Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH) (ENLIVEN)

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ClinicalTrials.gov Identifier: NCT04929483
Recruitment Status : Active, not recruiting
First Posted : June 18, 2021
Last Update Posted : February 13, 2024
Sponsor:
Information provided by (Responsible Party):
89bio, Inc.

Study Description
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Brief Summary:
This is a randomized, double-blind, placebo-controlled study that will evaluate the safety, efficacy, tolerability of BIO89-100 in patients with biopsy-confirmed fibrosis stages F2-F3 NASH.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Drug: BIO89-100 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BIO89-100 in Subjects With Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : June 4, 2021
Actual Primary Completion Date : February 14, 2023
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: BIO89-100 - 15 mg QW Drug: BIO89-100
Subcutaneous injection
Experimental: Experimental: BIO89-100 - 30 mg QW Drug: BIO89-100
Subcutaneous injection
Experimental: Experimental: BIO89-100 - 44 mg Q2W Drug: BIO89-100
Subcutaneous injection
Placebo Comparator: Placebo Comparator: Placebo QW Drug: BIO89-100
Subcutaneous injection
Placebo Comparator: Placebo Comparator: Placebo Q2W Drug: BIO89-100
Subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Main: Proportion of participants with histological resolution of NASH without worsening of fibrosis [ Time Frame: 24 Weeks ]
  2. Main: Proportion of participants with ≥1 stage decrease in fibrosis stage with no worsening of NASH [ Time Frame: 24 Weeks ]

Secondary Outcome Measures :
  1. Main: Proportion of participants with at least a 2-point improvement in NAS and no worsening of fibrosis [ Time Frame: 24 Weeks ]
  2. Main: Proportion of participants with NASH resolution AND with ≥1 stage decrease in fibrosis stage [ Time Frame: 24 Weeks ]
  3. Main: Proportion of participants with at least a 2-point improvement in NAS and are MRI-PDFF responders AND ALT responders [ Time Frame: 24 Weeks ]
  4. Main: Absolute and percentage change from baseline in serum triglycerides [ Time Frame: 12 Weeks, 24 Weeks ]
  5. Main: Absolute and percentage change from baseline in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: 12 Weeks, 24 Weeks ]
  6. Main: Absolute change and percentage change from baseline in Alanine Transaminase (ALT) [ Time Frame: 12 Weeks, 24 Weeks, 48 Weeks ]
  7. Main: Absolute change and percentage change from baseline in N-terminal type III collagen propeptide (Pro-C3) [ Time Frame: 12 Weeks, 24 Weeks, 48 Weeks ]
  8. Main: Absolute change and percentage change from baseline in Magnetic Resonance Imaging - Hepatic Fat Fraction (MRI-PDFF) [ Time Frame: 12 Weeks, 24 Weeks, 48 Weeks ]
  9. Main: Percentage change from baseline in HbA1c [ Time Frame: 12 Weeks, 24 Weeks ]
  10. Main: Absolute and percentage change from baseline in Adiponectin [ Time Frame: 12 Weeks, 24 Weeks ]
  11. Main: Steady-state blood level of BIO89-100 [ Time Frame: Blood samples for PK analysis collected at up to 8 study visits over the course of approximately 48 weeks ]
    Plasma trough concentration (ng/mL) of BIO89-100 taken at pre-dose samples

  12. Main: Absolute and percentage change from baseline in Non High Density Lipoprotein (HDL) Cholesterol [ Time Frame: 12 Weeks, 24 Weeks ]
  13. Main: Absolute and percentage change from baseline in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: 12 Weeks, 24 Weeks ]

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:

  • Age 21 to 75

  • Biopsy-confirmed NASH with fibrosis stage F2 or F3 per NASH CRN System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation.

    • Qualifying biopsy must be either within 6 months of screening visit or obtained during screening period

Key Exclusion Criteria:

  • Have poorly controlled high blood pressure
  • Have type 1 diabetes or poorly controlled type 2 diabetes.
  • History of cirrhosis or evidence of cirrhosis by clinical, imaging or liver biopsy evaluation
  • Are planning to try to lose weight during the conduct of the study.
  • Have a BMI <25 kg/m2

Other inclusion and exclusion criteria may apply.

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): NCT04929483


Locations
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Sponsors and Collaborators
89bio, Inc.
Investigators
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Study Director: Millie Gottwald, PharmD 89bio, Inc.
More Information
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Responsible Party: 89bio, Inc.
ClinicalTrials.gov Identifier: NCT04929483    
Other Study ID Numbers: BIO89-100-122
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: February 13, 2024
Last Verified: February 2024

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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.:
Liver Diseases
Fatty Liver
Digestive System Diseases
 Non-alcoholic Fatty Liver Disease
Metabolic diseases
NASH NAFLD
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases