Phase 3
N=919
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Compensated Cirrhosis · Nonalcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT03439254 ↗Enrolled (actual)
919
Serious AEs
16.6%
Results posted
Oct 2023
Primary outcome: Primary: DB Phase: Number of Participants Who Were Responders and Showed Improvement in Fibrosis by at Least 1 Stage Without Worsening of Nonalcoholic Steatohepatitis (NASH) — 31; 33; 37 Participants — p=0.6172
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Obeticholic acid (10 mg) (Drug); Obeticholic acid (10 mg to 25 mg) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intercept Pharmaceuticals
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DB Phase: Number of Participants Who Were Responders and Showed Improvement in Fibrosis by at Least 1 Stage Without Worsening of Nonalcoholic Steatohepatitis (NASH) |
31; 33; 37 | 0.6172 |
| PRIMARY OLE Phase: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) |
199; 213; 197; 26; 50; 48 | — |
| PRIMARY OLE Phase: Change From Baseline to Month 12 in Liver Stiffness Measurement (LSM) |
-2.10; -2.90; -3.45 | — |
| PRIMARY OLE Phase: Fibrosis-4 (FIB-4) at Baseline |
2.179; 2.267; 2.266 | — |
| PRIMARY OLE Phase: Enhanced Liver Fibrosis (ELF) at Baseline |
10.46; 10.50; 10.48 | — |
| PRIMARY OLE Phase: Number of Participants Reporting All-cause Mortality |
1; 0; 1 | — |
| PRIMARY OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Ascites, Hepatocellular Carcinoma (HCC) and Non-liver Related Death |
1; 0; 2; 3; 1; 1 | — |
| PRIMARY OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Worsening of Child-Pugh Score |
0; 1; 2 | — |
| PRIMARY OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Model for End-Stage Liver Disease (MELD) Score ≥15 |
0; 0; 1 | — |
| SECONDARY DB Phase: Change From Baseline to Month 18 in LSM |
-0.50; -3.10; -2.90 | — |
| SECONDARY DB Phase: FIB-4 at Baseline |
2.279; 2.475; 2.405 | — |
| SECONDARY DB Phase: ELF at Baseline |
10.50; 10.60; 10.61 | — |
Summary
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
Eligibility Criteria
Key inclusion criteria
- Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading
Key exclusion criteria
- Current or past history of a clinically evident hepatic decompensation event, such as ascites, hepatic encephalopathy (HE), or variceal bleeding
- Current or past history of CP score ≥7 points
- Model for End-stage Liver Disease (MELD) score > 12
- ALT ≥ 5 X ULN
- Calculated creatinine clearance <60mL/min using Cockcroft-Gault method
- Hemoglobin A1c (HbA1c) ≥ 9.5 %
- Evidence of other known forms of chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC)
- History of liver transplant, or current placement on a liver transplant list
Data sourced from ClinicalTrials.gov (NCT03439254). 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.