Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04929483
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : January 25, 2022
Sponsor:
Information provided by (Responsible Party):
89bio, Inc.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 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
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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




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

Secondary Outcome Measures :
  1. Proportion of participants with at least a 2-point improvement in NAS and no worsening of fibrosis [ Time Frame: 24 Weeks ]
  2. Proportion of participants with NASH resolution AND with ≥1 stage decrease in fibrosis stage [ Time Frame: 24 Weeks ]
  3. Absolute and percentage change from baseline in serum triglycerides [ Time Frame: 12 Weeks, 24 Weeks, 48 Weeks ]
  4. Absolute and percentage change from baseline in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: 12 Weeks, 24 Weeks, 48 weeks ]
  5. Mean absolute change and percentage change from baseline in Alanine Transaminase (ALT) [ Time Frame: 12 Weeks, 24 Weeks, 48 Weeks ]
  6. Absolute change and percentage change from baseline in N-terminal type III collagen propeptide (Pro-C3) [ Time Frame: 12 Weeks, 24 Weeks, 48 Weeks ]
  7. Absolute change and percentage change from baseline in Magnetic Resonance Imaging - Hepatic Fat Fraction (MRI-PDFF) [ Time Frame: 12 Weeks, 24 Weeks, 48 Weeks ]
  8. Percentage change from baseline in HbA1c [ Time Frame: 12 Weeks, 24 Weeks, 48 Weeks ]
  9. Absolute and percentage change from baseline in Adiponectin [ Time Frame: 12 Weeks, 24 Weeks, 48 Weeks ]
  10. 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

  11. Absolute and percentage change from baseline in Non High Density Lipoprotein (HDL) Cholesterol [ Time Frame: 12 Weeks, 24 Weeks, 48 Weeks ]
  12. Absolute and percentage change from baseline in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: 12 Weeks, 24 Weeks, 48 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.


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


Contacts
Layout table for location contacts
Contact: Clinical Trial Lead 1-408-332-4389 enliven@89bio.com

Locations
Show Show 78 study locations
Sponsors and Collaborators
89bio, Inc.
Investigators
Layout table for investigator information
Study Director: Millie Goattwald, PharmD 89bio, Inc.
Layout table for additonal information
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: January 25, 2022
Last Verified: January 2022

Layout table for additional information
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:
Layout table for MeSH terms
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases