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

February 9, 2024 updated by: 89bio, Inc.

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)

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • San Juan, Puerto Rico, 00927
        • 89bio Clinical Study Site
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • 89bio Clinical Study Site
      • Birmingham, Alabama, United States, 35211
        • 89bio Clinical Study Site
      • Dothan, Alabama, United States, 36305
        • 89bio Clinical Study Site
      • Guntersville, Alabama, United States, 35976
        • 89bio Clinical Study Site
      • Madison, Alabama, United States, 35758
        • 89bio Clinical Study Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • 89bio Clinical Study Site
      • Glendale, Arizona, United States, 85036
        • 89bio Clinical Study Site
      • Peoria, Arizona, United States, 85306
        • 89bio Clinical Study Site
      • Tucson, Arizona, United States, 85712-4044
        • 89bio Clinical Study Site
      • Tucson, Arizona, United States, 85712-4046
        • 89bio Clinical Study Site
      • Tucson, Arizona, United States, 85741
        • 89bio Clinical Study Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205-6414
        • 89bio Clinical Study Site
      • Little Rock, Arkansas, United States, 72205
        • 89bio Clinical Study Site
    • California
      • Chula Vista, California, United States, 91911
        • 89bio Clinical Study Site
      • Huntington Park, California, United States, 90255
        • 89bio Clinical Study Site
      • Long Beach, California, United States, 90808
        • 89bio Clinical Study Site
      • Orange, California, United States, 92866
        • 89bio Clinical Study Site
      • Panorama City, California, United States, 91402
        • 89bio Clinical Study Site
      • Rialto, California, United States, 92377
        • 89bio Clinical Study Site
      • Santa Ana, California, United States, 92704
        • 89bio Clinical Study Site
    • Colorado
      • Englewood, Colorado, United States, 80113
        • 89bio Clinical Study Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • 89bio Clinical Study Site
      • Bradenton, Florida, United States, 34208
        • 89bio Clinical Study Site
      • Fort Myers, Florida, United States, 33912
        • 89bio Clinical Study Site
      • Lakeland, Florida, United States, 33805
        • 89bio Clinical Study Site
      • Maitland, Florida, United States, 32127
        • 89bio Clinical Study Site
      • Miami, Florida, United States, 33014
        • 89bio Clinical Study Site
      • Miami, Florida, United States, 33147
        • 89bio Clinical Study Site
      • Miami, Florida, United States, 33157
        • 89bio Clinical Study Site
      • Miami Lakes, Florida, United States, 33016
        • 89bio Clinical Study Site
      • Ocala, Florida, United States, 34471
        • 89bio Clinical Study Site
      • Palmetto Bay, Florida, United States, 33157
        • 89bio Clinical Study Site
      • Pinellas Park, Florida, United States, 33781
        • 89bio Clinical Study Site
      • Port Orange, Florida, United States, 32127
        • 89bio Clinical Study Site
      • Sarasota, Florida, United States, 34240
        • 89bio Clinical Study Site
      • Viera, Florida, United States, 32940
        • 89bio Clinical Study Site
    • Georgia
      • Athens, Georgia, United States, 30607
        • 89bio Clinical Study Site
      • Sandy Springs, Georgia, United States, 30328
        • 89bio Clinical Study Site
    • Indiana
      • New Albany, Indiana, United States, 47150
        • 89bio Clinical Study Site
      • South Bend, Indiana, United States, 46635
        • 89bio Clinical Study Site
    • Iowa
      • Iowa City, Iowa, United States, 52246
        • 89bio Clinical Study Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • 89bio Clinical Study Site
    • Louisiana
      • Marrero, Louisiana, United States, 70072-3151
        • 89bio Clinical Study Site
      • Marrero, Louisiana, United States, 70072-3155
        • 89bio Clinical Study Site
      • Monroe, Louisiana, United States, 71201
        • 89bio Clinical Study Site
      • Shreveport, Louisiana, United States, 71103
        • 89bio Clinical Study Site
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • 89bio Clinical Study Site
      • Greenbelt, Maryland, United States, 20770
        • 89bio Clinical Study Site
    • Missouri
      • Saint Louis, Missouri, United States, 63033
        • 89bio Clinical Study Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • 89bio Clinical Study Site
      • Las Vegas, Nevada, United States, 89121
        • 89bio Clinical Study Site
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • 89bio Clinical Study Site
    • New York
      • New York, New York, United States, 10033
        • 89bio Clinical Study Site
    • North Carolina
      • Concord, North Carolina, United States, 28027
        • 89bio Clinical Study Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • 89bio Clinical Study Site
      • Dayton, Ohio, United States, 45414
        • 89bio Clinical Study Site
      • Springboro, Ohio, United States, 45066
        • 89bio Clinical Study Site
      • Westlake, Ohio, United States, 44145
        • 89bio Clinical Study Site
    • South Carolina
      • Greenwood, South Carolina, United States, 29646
        • 89bio Clinical Study Site
      • Summerville, South Carolina, United States, 29485
        • 89bio Clinical Study Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • 89bio Clinical Study Site
      • Chattanooga, Tennessee, United States, 37411
        • 89bio Clinical Study Site
      • Hermitage, Tennessee, United States, 37076
        • 89bio Clinical Study Site
    • Texas
      • Austin, Texas, United States, 78757-8051
        • 89bio Clinical Study Site
      • Austin, Texas, United States, 78757-8059
        • 89bio Clinical Study Site
      • Beaumont, Texas, United States, 77702
        • 89bio Clinical Study Site
      • Dallas, Texas, United States, 75234
        • 89bio Clinical Study Site
      • Dallas, Texas, United States, 75246
        • 89bio Clinical Study Site
      • Edinburg, Texas, United States, 78539
        • 89bio Clinical Study Site
      • Fort Worth, Texas, United States, 76104
        • 89bio Clinical Study Site
      • Garland, Texas, United States, 75044
        • 89bio Clinical Study Site
      • Houston, Texas, United States, 77030
        • 89bio Clinical Study Site
      • Houston, Texas, United States, 77099
        • 89bio Clinical Study Site
      • San Antonio, Texas, United States, 78215
        • 89bio Clinical Study Site
      • San Antonio, Texas, United States, 78209
        • 89bio Clinical Study Site
      • San Antonio, Texas, United States, 78229-4801
        • 89bio Clinical Study Site
      • San Antonio, Texas, United States, 78229-5069
        • 89bio Clinical Study Site
      • Waco, Texas, United States, 76710
        • 89bio Clinical Study Site
      • Waco, Texas, United States, 76712
        • 89bio Clinical Study Site
      • Wichita Falls, Texas, United States, 76301
        • 89bio Clinical Study Site
    • Utah
      • Ogden, Utah, United States, 84405
        • 89bio Clinical Study Site
      • Sandy, Utah, United States, 84092
        • 89bio Clinical Study Site
    • Virginia
      • Manassas, Virginia, United States, 20110
        • 89bio Clinical Study Site
      • Richmond, Virginia, United States, 23235
        • 89bio Clinical Study Site
      • Richmond, Virginia, United States, 23249
        • 89bio Clinical Study Site
      • Roanoke, Virginia, United States, 24014
        • 89bio Clinical Study Site
    • Washington
      • Seattle, Washington, United States, 98105
        • 89bio Clinical Study Site
      • Spokane, Washington, United States, 99202
        • 89bio Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIO89-100 - 15 mg QW
Subcutaneous injection
Experimental: Experimental: BIO89-100 - 30 mg QW
Subcutaneous injection
Experimental: Experimental: BIO89-100 - 44 mg Q2W
Subcutaneous injection
Placebo Comparator: Placebo Comparator: Placebo QW
Subcutaneous injection
Placebo Comparator: Placebo Comparator: Placebo Q2W
Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Main: Proportion of participants with histological resolution of NASH without worsening of fibrosis
Time Frame: 24 Weeks
24 Weeks
Main: Proportion of participants with ≥1 stage decrease in fibrosis stage with no worsening of NASH
Time Frame: 24 Weeks
24 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main: Proportion of participants with at least a 2-point improvement in NAS and no worsening of fibrosis
Time Frame: 24 Weeks
24 Weeks
Main: Proportion of participants with NASH resolution AND with ≥1 stage decrease in fibrosis stage
Time Frame: 24 Weeks
24 Weeks
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
24 Weeks
Main: Absolute and percentage change from baseline in serum triglycerides
Time Frame: 12 Weeks, 24 Weeks
12 Weeks, 24 Weeks
Main: Absolute and percentage change from baseline in Low Density Lipoprotein (LDL) Cholesterol
Time Frame: 12 Weeks, 24 Weeks
12 Weeks, 24 Weeks
Main: Absolute change and percentage change from baseline in Alanine Transaminase (ALT)
Time Frame: 12 Weeks, 24 Weeks, 48 Weeks
12 Weeks, 24 Weeks, 48 Weeks
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
12 Weeks, 24 Weeks, 48 Weeks
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
12 Weeks, 24 Weeks, 48 Weeks
Main: Percentage change from baseline in HbA1c
Time Frame: 12 Weeks, 24 Weeks
12 Weeks, 24 Weeks
Main: Absolute and percentage change from baseline in Adiponectin
Time Frame: 12 Weeks, 24 Weeks
12 Weeks, 24 Weeks
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
Blood samples for PK analysis collected at up to 8 study visits over the course of approximately 48 weeks
Main: Absolute and percentage change from baseline in Non High Density Lipoprotein (HDL) Cholesterol
Time Frame: 12 Weeks, 24 Weeks
12 Weeks, 24 Weeks
Main: Absolute and percentage change from baseline in High Density Lipoprotein (HDL) Cholesterol
Time Frame: 12 Weeks, 24 Weeks
12 Weeks, 24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Millie Gottwald, PharmD, 89bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2021

Primary Completion (Actual)

February 14, 2023

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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