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ISIS-FGFR4RX

Phase 2

Obesity | Small molecule | Metabolic |Ionis Pharmaceuticals, Inc.|Last Updated: Jun 25, 2018

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02476019A Safety, Tolerability, PK, and PD Study of Once Weekly ISIS-FGFR4RX SC in Obese PatientsPHASE2 COMPLETED 13 — — Jun 1, 2015Sep 1, 2016Jun 25, 20181 United States
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Study Endpoints
Primary Endpoints
Energy Expenditure using both room calorimetry and hood (metabolic cart) calorimetry
From baseline to the average of weeks 14 and 16

As measured by: * Resting Metabolic rate (kcal/min) * Resting metabolic rate adjusted for changes in body composition (kcal/min) * Resting fat oxidation (grams/24 hr)

Secondary Endpoints
Safety and Tolerability will be assessed by determining the incidence, and severity of adverse effects and changes in laboratory evaluations within each treatment group.
33 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ISIS-FGFR4RXEXPERIMENTALISIS-FGFR4RX administered subcutaneously
PlaceboPLACEBO_COMPARATORPlacebo administered subcutaneously
Interventions
NameTypeDescription
ISIS-FGFR4RXDRUGISIS-FGFR4RX administered subcutaneously
PlaceboDRUGPlacebo administered subcutaneously
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements 2. Male or female patients between the age of 18-65 years, inclusive * Females: Must be post-menopausal (defined as 1...

Countries:United States
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