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ISIS-FGFR4RX

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

ISIS-FGFR4RX · 1 trial · 1 indication

Phase 2 1
NCT02476019A Safety, Tolerability, PK, and PD Study of Once Weekly ISIS-FGFR4RX SC in Obese PatientsObesity
COMPLETED13 Analytics
PHASE2COMPLETED
A Safety, Tolerability, PK, and PD Study of Once Weekly ISIS-FGFR4RX SC in Obese Patients
ObesityUnlock trial analytics

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 to 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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Frequently asked questions about ISIS-FGFR4RX

What is ISIS-FGFR4RX used for?

ISIS-FGFR4RX is an investigational small molecule being developed for the treatment of obesity. It is a Phase 2 drug candidate that has been studied in obese patients to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.

Who makes ISIS-FGFR4RX?

ISIS-FGFR4RX is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical research on this drug candidate for obesity.

What phase is ISIS-FGFR4RX in?

ISIS-FGFR4RX is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to assess its safety and other characteristics in obese patients.

What clinical trials is ISIS-FGFR4RX in?

ISIS-FGFR4RX has been studied in one completed Phase 2 clinical trial with the identifier NCT02476019. This trial was a randomized, double-blind, placebo-controlled study conducted in the United States, enrolling 13 obese patients aged 18 years and older.

Is ISIS-FGFR4RX the same as any other drug?

ISIS-FGFR4RX is the drug name used in clinical trials. No alternative names have been reported for this investigational candidate. It is being studied under this name by Ionis Pharmaceuticals for the treatment of obesity.