Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03517540 | Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis | PHASE2 | COMPLETED | 193 | — | — | Sep 11, 2018 | Oct 15, 2020 | Apr 29, 2022 | 65 | United States, Argentina +15 |
Occurrence of adverse events and serious adverse events Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and then up to 66 weeks
| Arm | Type | Description |
|---|---|---|
| Arm A: Tropifexor (LJN452) - Dose 1 | EXPERIMENTAL | tropifexor 140 mcg, once daily; given orally |
| Arm B: Cenicriviroc (CVC) | EXPERIMENTAL | CVC 150 mg, once daily; given orally |
| Arm C: Tropifexor (LJN452) Dose 1 + CVC | EXPERIMENTAL | tropifexor 140 mcg + CVC 150 mg, once daily; given orally |
| Arm D: Tropifexor Dose 2 + CVC | EXPERIMENTAL | tropifexor 90 mcg + CVC 150 mg, once daily; given orally |
| Name | Type | Description |
|---|---|---|
| Tropifexor (LJN452) | DRUG | Comparison with monotherapy and different combination doses |
| Cenicriviroc (CVC) | DRUG | Comparison with monotherapy and different combination doses |
Inclusion Criteria: Written informed consent Male and female patients 18 years or older (at the time of the screening visit). Patients must weigh at least 50 kg (110 lb) and no more than 200 kg (440 lb) to participate in the study. Able to communicate well with the investigator, to understand and ...