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triopifexor

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment89
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04408937The Purpose of This Study is to Investigate Safety and Tolerability of Tropifexor.PHASE1 COMPLETED 89May 29, 2020Nov 4, 2020Feb 9, 202210 United States
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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 — 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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