Phase 2
Completed N=47
A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects
NASH - Nonalcoholic Steatohepatitis · Fibrosis, Liver · NAFLD - Nonalcoholic Fatty Liver Disease
Source: ClinicalTrials.gov NCT04480710 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Number of Safety and Tolerability Events of CRV431 Versus Placebo. — 4; 8; 3; 21 Number of treatment emergent AE
Summary
This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Safety and Tolerability Events of CRV431 Versus Placebo. |
4; 8; 3; 21; 4; 6 | — |
| PRIMARY Tmax, of Once Daily (QD) 75mg and 225mg mg Doses of CRV431 is Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects. |
4.41; 4; 2.59; 2 | — |
| PRIMARY Cmax, of Once Daily (QD) 75mg and 22mg mg Doses of CRV431 is Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects. |
347.24; 1147.31; 1218.88; 1876.9 | — |
| PRIMARY AUC 0-last, of Once Daily (QD) 75mg and 225mg mg Doses of CRV431 in Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects. |
2251.32; 8851.96; 6348.85; 13784.34 | — |
Eligibility Criteria
Key Inclusion Criteria
- Male or female between 18 and 75 years of age (inclusive).
- Capable of giving written informed consent and able to effectively communicate with the investigator and study personnel.
- Presumed F2/F3 NASH to include: AST >20 IU/L, Pro-C3 >15.5 ng/mL, enhanced liver fibrosis (ELF) score >9.8, and FibroScan >8.5 kPa values.
Key Exclusion Criteria
- Pregnant or breastfeeding or planning to become pregnant during the study period.
- Known allergy to CRV431, cyclosporine, or any of their inactive ingredients.
- Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus antibodies (HIVAb).
- Well documented causes of chronic liver disease according to standard diagnostic procedures to include any history or presence of decompensated cirrhosis.
- Subjects with a platelet count 9.5%.
- Weight loss of more than 5% within 3 months prior to randomization.
- Subjects with a blood pressure to include a systolic pressure >150 or a diastolic pressure >90.
- At Screening, an estimated glomerular filtration rate (eGFR) G2.
- Subjects with a history of organ transplantation. Corneal transplantation will be allowed.
Data sourced from ClinicalTrials.gov (NCT04480710). 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. Informational only — not medical advice.