Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LJN452
triopifexor · 4 trials · 4 indications
Number of patients reported with adverse events , serious adverse events and death.
Stool frequency at Baseline, Week 1 (Period 1 \& Period 2), Week 2 (Period 1 \& Period 2), and Week 1 \& 2 combined
Stool Form at Baseline, Week 1 (Period 1 \& Period 2), Week 2 (Period 1 \& Period 2), and Week 1 \& 2 combined Clinical Symptoms will be measured as change from baseline in stool types per Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify feces on a scale from 1 to 7 according to increasing wateriness.
Fold change in serum gamma-glutamyl transferase (GGT) from baseline to Day 28
Vital signs - Systolic Blood pressure
Vital signs
Vital signs
Electrocardiogram (ECG)
Electrocardiogram (ECG)
Hematology panel for safety laboratory assessments.
The maximum (peak) observed drug concentration after single dose administration (mass x volume-1)
Time to reach the maximum (peak) plasma drug concentration after single dose administration (time)
The area under the concentration-time curve from time zero to the time of the last quantifiable concentration sampling time (mass x time x volume-1)
The area under the concentration-time curve from time zero to infinity (mass x time x volume-1)
The elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve
The apparent total body clearance of the drug from plasma (volume x time-1)
The apparent volume of distribution during the terminal phase
| Arm | Type | Description |
|---|---|---|
| LJN452 followed by placebo | EXPERIMENTAL | Randomized patients in this arm will receive single oral dose of LJN452 daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of placebo daily for 14 days. |
| Placebo followed by LJN452 | EXPERIMENTAL | Randomized patients in this arm will receive single oral dose of placebo daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of LJN452 daily for 14 days. |
| LJN452 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| tropifexor AM 200 micrograms and Placebo (PM) | EXPERIMENTAL | Tropifexor 200 μg (AM) and Placebo (PM) once daily each |
| tropifexor PM 200 micrograms and Placebo (AM) | EXPERIMENTAL | Tropifexor 200 μg (PM) and Placebo (AM) once daily each |
| Group 1 - Normal Hepatic Function | OTHER | Normal hepatic function - Control - control group |
| Group 2 - Mild Hepatic Impairment | EXPERIMENTAL | Mild hepatic impairment - Child-Pugh A (Score 5-6) |
| Group 3 - Moderate Hepatic Impairment | EXPERIMENTAL | Moderate hepatic impairment - Child-Pugh B (Score 7-9) |
| Group 4 - Severe Hepatic Impairment | EXPERIMENTAL | Severe hepatic impairment - Child-Pugh C (score 10-15) |
| Name | Type | Description |
|---|---|---|
| LJN452 | DRUG | Capsules containing LJN452 |
| Placebo to LJN452 | DRUG | Capsules containing placebo to LJN452 |
| Part 1: LJN452 | DRUG | LJN452 capsules administered once daily for 28 days |
| Part 1: Placebo | DRUG | Matching placebo capsules administered once daily for 28 days |
| Part 2: LJN452 Dose level 1 | DRUG | LJN452 capsules administered once a day for 12 weeks |
| Part 2: Placebo | DRUG | Matching placebo to LJN452 administered once a day for 12 weeks |
| Part 2: LJN452 Dose level 2 | DRUG | LJN452 |
| triopifexor | DRUG | Tropifexor as a dry blend in hard gelatin capsules for oral administration |
| Placebo | DRUG | Placebo capsules for oral administration |
Key Inclusion Criteria: * A history of diarrheal symptoms for at least 3 months prior to dosing - Average stool frequency of at least 2 per day when off therapy AND Average stool form of \>5 on Bristol Stool Chart. * Previous laboratory or radiological confirmation of bile acid malabsorption with e...
Triopifexor is an investigational small molecule being developed for the treatment of liver disease. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and tolerability in patients.
Triopifexor is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and tolerability in patients with liver disease.
Triopifexor is in Phase 1 clinical development. A Phase 1 trial has been completed, which enrolled 89 participants with liver disease in the United States. The drug remains investigational and is not yet approved for any use.
Triopifexor has one completed Phase 1 clinical trial registered under NCT04408937, titled 'The Purpose of This Study is to Investigate Safety and Tolerability of Tropifexor.' The study enrolled 89 participants with liver disease in the United States and was a randomized, double-blind, controlled trial.
Triopifexor is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial focused on evaluating safety and tolerability, and the drug has not yet progressed to later-stage trials or received regulatory approval.