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triopifexor

Phase 1

Liver Disease | Small molecule | Gastrointestinal |Novartis AG|Last Updated: Feb 9, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment89

FDA Designations

No designations recorded

Clinical trial landscape

triopifexor · 1 trial · 1 indication

Phase 1 1
NCT04408937The Purpose of This Study is to Investigate Safety and Tolerability of Tropifexor.Liver Disease
COMPLETED89 Analytics
PHASE1COMPLETED
The Purpose of This Study is to Investigate Safety and Tolerability of Tropifexor.
Liver DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in fasting circulating LDL-C levels after 2 weeks of tropifexor treatment
week 2

Secondary Endpoints

Change in fasting circulating High density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) levels over 4 weeks of treatment
week 4
Change in ALT, AST and GGT over 4 weeks of treatment
week 4
PK parameters include but not limited to Cmax (ng/ml) will be assessed in the domiciled patients
week 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
tropifexor AM 200 micrograms and Placebo (PM)EXPERIMENTALTropifexor 200 μg (AM) and Placebo (PM) once daily each
tropifexor PM 200 micrograms and Placebo (AM)EXPERIMENTALTropifexor 200 μg (PM) and Placebo (AM) once daily each

Interventions

NameTypeDescription
triopifexorDRUGTropifexor as a dry blend in hard gelatin capsules for oral administration
PlaceboDRUGPlacebo capsules for oral administration
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: -Presence of Liver Disease Exclusion Criteria: * Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations. * Subjects taking the following medicines UN...

Countries:United States
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Frequently asked questions about triopifexor

What is triopifexor used for?

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.

Who makes triopifexor?

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.

What phase is triopifexor in?

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.

What clinical trials is triopifexor in?

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.

Is triopifexor FDA approved?

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.