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Also known as Tropifexor (LJN452)
Tropifexor · 1 trial · 1 indication
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 ...
Tropifexor is an investigational small molecule being studied for the treatment of non-alcoholic steatohepatitis (NASH), a progressive liver disease. It is not approved for any indication and remains in clinical development. The Phase 2 program evaluated it in adults with NASH and liver fibrosis.
Tropifexor targets NR1H4, also known as the farnesoid X receptor (FXR). It acts as an agonist at this nuclear receptor. NR1H4 agonism is the mechanism under investigation for its effects in NASH and liver fibrosis.
Tropifexor is being developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 2 clinical trial of the drug in patients with NASH and liver fibrosis.
Tropifexor is in Phase 2 development. It is an investigational drug and has not been approved by the FDA or any regulatory agency. The completed Phase 2 trial evaluated the combination of Tropifexor and CVC in adults with NASH and liver fibrosis.
Tropifexor has been studied in one completed Phase 2 trial, NCT03517540, titled a study of safety, tolerability, and efficacy of a combination treatment of LJN452 and CVC in adult patients with NASH and liver fibrosis. The trial enrolled 193 participants across multiple countries.
Yes, Tropifexor is also known as LJN452. LJN452 is the code name used for the same investigational compound in its clinical development. Both names refer to the same small molecule being developed by Novartis for NASH.