Clinical trial NCT04929483: Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: Liver Diseases
Fatty Liver
Digestive System Diseases
Non-alcoholic Fatty Liver Disease
Metabolic diseases
NASH NAFLD
Lead sponsor: 89bio, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-18
Enrollment: 222
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Main: Proportion of participants with histological resolution of NASH without worsening of fibrosis
timeFrame: 24 Weeks
measure: Main: Proportion of participants with ≥1 stage decrease in fibrosis stage with no worsening of NASH
timeFrame: 24 Weeks
Secondary outcomes:
measure: Main: Proportion of participants with at least a 2-point improvement in NAS and no worsening of fibrosis
timeFrame: 24 Weeks
measure: Main: Proportion of participants with NASH resolution AND with ≥1 stage decrease in fibrosis stage
timeFrame: 24 Weeks
measure: Main: Proportion of participants with at least a 2-point improvement in NAS and are MRI-PDFF responders AND ALT responders
timeFrame: 24 Weeks
measure: Main: Absolute and percentage change from baseline in serum triglycerides
timeFrame: 12 Weeks, 24 Weeks
measure: Main: Absolute and percentage change from baseline in Low Density Lipoprotein (LDL) Cholesterol
timeFrame: 12 Weeks, 24 Weeks
measure: Main: Absolute change and percentage change from baseline in Alanine Transaminase (ALT)
timeFrame: 12 Weeks, 24 Weeks, 48 Weeks
measure: Main: Absolute change and percentage change from baseline in N-terminal type III collagen propeptide (Pro-C3)
timeFrame: 12 Weeks, 24 Weeks, 48 Weeks
measure: Main: Absolute change and percentage change from baseline in Magnetic Resonance Imaging - Hepatic Fat Fraction (MRI-PDFF)
timeFrame: 12 Weeks, 24 Weeks, 48 Weeks
measure: Main: Percentage change from baseline in HbA1c
timeFrame: 12 Weeks, 24 Weeks
measure: Main: Absolute and percentage change from baseline in Adiponectin
timeFrame: 12 Weeks, 24 Weeks
measure: Main: Steady-state blood level of BIO89-100
timeFrame: Blood samples for PK analysis collected at up to 8 study visits over the course of approximately 48 weeks
measure: Main: Absolute and percentage change from baseline in Non High Density Lipoprotein (HDL) Cholesterol
timeFrame: 12 Weeks, 24 Weeks
measure: Main: Absolute and percentage change from baseline in High Density Lipoprotein (HDL) Cholesterol
timeFrame: 12 Weeks, 24 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 89bio Clinical Study Site
state: Alabama
city: Birmingham
country: United States
facility: 89bio Clinical Study Site
state: Alabama
city: Dothan
country: United States
facility: 89bio Clinical Study Site
state: Alabama
city: Guntersville
country: United States
facility: 89bio Clinical Study Site
state: Alabama
city: Madison
country: United States
facility: 89bio Clinical Study Site
state: Alabama
city: Chandler
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Glendale
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Peoria
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Tucson
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Tucson
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Tucson
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Little Rock
country: United States
facility: 89bio Clinical Study Site
state: Arkansas
city: Little Rock
country: United States
facility: 89bio Clinical Study Site
state: Arkansas
city: Chula Vista
country: United States
facility: 89bio Clinical Study Site
state: California
city: Huntington Park
country: United States
facility: 89bio Clinical Study Site
state: California
city: Long Beach
country: United States
facility: 89bio Clinical Study Site
state: California
city: Orange
country: United States
facility: 89bio Clinical Study Site
state: California
city: Panorama City
country: United States
facility: 89bio Clinical Study Site
state: California
city: Rialto
country: United States
facility: 89bio Clinical Study Site
state: California
city: Santa Ana
country: United States
facility: 89bio Clinical Study Site
state: California
city: Englewood
country: United States
facility: 89bio Clinical Study Site
state: Colorado
city: Boynton Beach
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Bradenton
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Fort Myers
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Lakeland
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Maitland
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Miami Lakes
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Miami
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Miami
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Miami
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Ocala
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Palmetto Bay
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Pinellas Park
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Port Orange
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Sarasota
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Viera
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Athens
country: United States
facility: 89bio Clinical Study Site
state: Georgia
city: Sandy Springs
country: United States
facility: 89bio Clinical Study Site
state: Georgia
city: New Albany
country: United States
facility: 89bio Clinical Study Site
state: Indiana
city: South Bend
country: United States
facility: 89bio Clinical Study Site
state: Indiana
city: Iowa City
country: United States
facility: 89bio Clinical Study Site
state: Iowa
city: Topeka
country: United States
facility: 89bio Clinical Study Site
state: Kansas
city: Marrero
country: United States
facility: 89bio Clinical Study Site
state: Louisiana
city: Marrero
country: United States
facility: 89bio Clinical Study Site
state: Louisiana
city: Monroe
country: United States
facility: 89bio Clinical Study Site
state: Louisiana
city: Shreveport
country: United States
facility: 89bio Clinical Study Site
state: Louisiana
city: Glen Burnie
country: United States
facility: 89bio Clinical Study Site
state: Maryland
city: Greenbelt
country: United States
facility: 89bio Clinical Study Site
state: Maryland
city: Saint Louis
country: United States
facility: 89bio Clinical Study Site
state: Missouri
city: Las Vegas
country: United States
facility: 89bio Clinical Study Site
state: Nevada
city: Las Vegas
country: United States
facility: 89bio Clinical Study Site
state: Nevada
city: Florham Park
country: United States
facility: 89bio Clinical Study Site
state: New Jersey
city: New York
country: United States
facility: 89bio Clinical Study Site
state: New York
city: Concord
country: United States
facility: 89bio Clinical Study Site
state: North Carolina
city: Columbus
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Dayton
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Springboro
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Westlake
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Greenwood
country: United States
facility: 89bio Clinical Study Site
state: South Carolina
city: Summerville
country: United States
facility: 89bio Clinical Study Site
state: South Carolina
city: Chattanooga
country: United States
facility: 89bio Clinical Study Site
state: Tennessee
city: Chattanooga
country: United States
facility: 89bio Clinical Study Site
state: Tennessee
city: Hermitage
country: United States
facility: 89bio Clinical Study Site
state: Tennessee
city: Austin
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Austin
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Beaumont
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Edinburg
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Fort Worth
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Garland
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Houston
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Houston
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Waco
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Waco
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Wichita Falls
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Ogden
country: United States
facility: 89bio Clinical Study Site
state: Utah
city: Sandy
country: United States
facility: 89bio Clinical Study Site
state: Utah
city: Manassas
country: United States
facility: 89bio Clinical Study Site
state: Virginia
city: Richmond
country: United States
facility: 89bio Clinical Study Site
state: Virginia
city: Richmond
country: United States
facility: 89bio Clinical Study Site
state: Virginia
city: Roanoke
country: United States
facility: 89bio Clinical Study Site
state: Virginia
city: Seattle
country: United States
facility: 89bio Clinical Study Site
state: Washington
city: Spokane
country: United States
facility: 89bio Clinical Study Site
state: Washington
city: San Juan
country: Puerto Rico
facility: 89bio Clinical Study Site
Study officials:
affiliation: 89bio, Inc.
name: Millie Gottwald, PharmD
role: STUDY_DIRECTOR
References: