Phase 2
N=222
Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
NASH - Nonalcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT04929483 ↗Enrolled (actual)
222
Serious AEs
10.1%
Results posted
Jan 2026
Primary outcome: Primary: Main Study: Number of Participants With Histological Resolution of Nonalcoholic Steatohepatitis (NASH) Without Worsening of Fibrosis — 5; 12; 11; 1 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BIO89-100 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- 89bio, Inc.
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Main Study: Number of Participants With Histological Resolution of Nonalcoholic Steatohepatitis (NASH) Without Worsening of Fibrosis |
5; 12; 11; 1 | <0.0001 sig |
| PRIMARY Main Study: Number of Participants Who Achieved Improvement of Fibrosis ≥1 Stage Without Worsening of NASH |
3; 14; 11; 4 | 0.1039 |
| SECONDARY Main Study: Number of Participants With at Least a 2-Point Improvement in NAS and no Worsening of Fibrosis |
5; 34; 26; 13 | — |
| SECONDARY Main Study: Number of Participants With NASH Resolution and Fibrosis Improvement ≥1 Stage |
2; 7; 8; 0 | — |
| SECONDARY Main Study: Number of Participants With at Least a 2-point Improvement in NAS Score and Are Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) Responders and Alanine Aminotransferase (ALT) Responders |
4; 31; 22; 5 | — |
| SECONDARY Main Study: Percent Change From Baseline in Serum Triglycerides |
-5.79; -14.87; -7.79; 1.02 | — |
| SECONDARY Main Study: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-c) |
20.28; -0.42; -5.64; 0.32 | — |
| SECONDARY Main Study: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-c) |
-3.04; -6.94; -6.95; -0.46 | — |
| SECONDARY Main Study: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-c) |
4.69; 15.82; 7.31; -2.01 | — |
| SECONDARY Main Study: Percent Change From Baseline in Adiponectin |
22.73; 31.36; 26.60; -6.28 | — |
| SECONDARY Main Study: Percent Change From Baseline in HbA1c (Glycated Hemoglobin) |
-2.24; -3.74; -2.00; -0.52 | — |
| SECONDARY Main Study: Percent Change From Baseline in Alanine Transaminase |
-39.68; -42.04; -35.42; -8.62; -39.28; -42.73 | — |
| SECONDARY Main Study: Percent Change From Baseline in Hepatic Fat Fraction By Magnetic Resonance Imaging - (MRI-PDFF) |
-45.05; -57.07; -50.63; -0.53; -27.92; -51.05 | — |
| SECONDARY Main Study: Percent Change From Baseline in N-Terminal Type III Collagen Propeptide (Pro-C3) |
-35.34; -9.51; -13.84; 10.57; -17.10; -17.76 | — |
| SECONDARY Main Study: Trough Serum Concentration of Pegozafermin |
197.833; 534.289; 81.699; 168.127; 691.424; 84.033 | — |
| SECONDARY Main and Extension Study: Percent Change From Baseline in Alanine Transaminase |
-28.51; -45.08; -38.05; -5.03; -31.71 | — |
| SECONDARY Main and Extension Study: Percent Change From Baseline in N-Terminal Type III Collagen Propeptide (Pro-C3) |
-7.89; -16.82; -14.96; 1.64; -17.22 | — |
| SECONDARY Main and Extension Study: Percent Change From Baseline in Hepatic Fat Fraction By Magnetic Resonance Imaging - (MRI-PDFF) |
-23.93; -48.75; -25.93; -3.15; -59.14 | — |
| SECONDARY Main and Extension Study: Trough Serum Concentration of Pegozafermin |
206.54; 471.28; 111.00; 553.45 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
21; 63; 46; 42; 17; 1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04929483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.