Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
Phase 2
Completed
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT04929483
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Q2W Placebo Placebo Q2W Placebo QW (Main study)/ BIO89-100 - 30 mg QW (Extension) Placebo Placebo QW (Main study)/ BIO89-100 - 30 mg QW (Extension) BIO89-100 - 15 mg once weekly (QW) BIO89-100 BIO89-100 - 15 mg QW BIO89-100 - 44 mg once every 2 weeks (Q2W) BIO89-100 BIO89-100 - 44 mg Q2W Placebo QW Placebo Placebo QW Placebo QW (Main study)/ BIO89-100 - 30 mg QW (Extension) BIO89-100 Placebo QW (Main study)/ BIO89-100 - 30 mg QW (Extension) BIO89-100 - 30 mg QW BIO89-100 BIO89-100 - 30 mg QW
- Primary Outcome Measures
Name Time Method Main: Proportion of participants with ≥1 stage decrease in fibrosis stage with no worsening of NASH 24 Weeks Main: Proportion of participants with histological resolution of NASH without worsening of fibrosis 24 Weeks
- Secondary Outcome Measures
Name Time Method Main: Percentage change from baseline in HbA1c 12 Weeks, 24 Weeks Main: Proportion of participants with at least a 2-point improvement in NAS and no worsening of fibrosis 24 Weeks Main: Absolute and percentage change from baseline in serum triglycerides 12 Weeks, 24 Weeks Main: Absolute change and percentage change from baseline in N-terminal type III collagen propeptide (Pro-C3) 12 Weeks, 24 Weeks, 48 Weeks Main: Absolute and percentage change from baseline in Non High Density Lipoprotein (HDL) Cholesterol 12 Weeks, 24 Weeks Main: Proportion of participants with NASH resolution AND with ≥1 stage decrease in fibrosis stage 24 Weeks Main: Steady-state blood level of BIO89-100 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
Main: Absolute change and percentage change from baseline in Alanine Transaminase (ALT) 12 Weeks, 24 Weeks, 48 Weeks Main: Proportion of participants with at least a 2-point improvement in NAS and are MRI-PDFF responders AND ALT responders 24 Weeks Main: Absolute and percentage change from baseline in Low Density Lipoprotein (LDL) Cholesterol 12 Weeks, 24 Weeks Main: Absolute change and percentage change from baseline in Magnetic Resonance Imaging - Hepatic Fat Fraction (MRI-PDFF) 12 Weeks, 24 Weeks, 48 Weeks Main: Absolute and percentage change from baseline in Adiponectin 12 Weeks, 24 Weeks Main: Absolute and percentage change from baseline in High Density Lipoprotein (HDL) Cholesterol 12 Weeks, 24 Weeks
Trial Locations
- Locations (1)
89bio Clinical Study Site
🇵🇷San Juan, Puerto Rico