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ISIS apoC-III Rx

Phase 2

Hypertriglyceridemia | Small molecule | Metabolic |Ionis Pharmaceuticals, Inc.|Last Updated: Jan 27, 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

ISIS apoC-III Rx · 1 trial · 1 indication

Phase 2 1
NCT01529424Safety, Tolerability, and Pharmacokinetic Study of ISIS ApoC-III Rx in HypertriglyceridemiaHypertriglyceridemia
COMPLETED89 Analytics
PHASE2COMPLETED
Safety, Tolerability, and Pharmacokinetic Study of ISIS ApoC-III Rx in Hypertriglyceridemia
HypertriglyceridemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

VLDL apoC-III
92 Days

The effect of treatment with ISIS ApoC-III Rx or Placebo on fasting total apoC-III levels.

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALNon-extensive PK/non post-prandial
Group 2aEXPERIMENTALExtensive PK
Group 2bEXPERIMENTALPost-prandial assessment
Group 3EXPERIMENTALStable dose of fibrate
Group 4EXPERIMENTALFredrickson Type 1 dyslipidemia

Interventions

NameTypeDescription
ISIS apoC-III RxDRUGDose 1
PlaceboDRUGDose 1
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Severe hypertriglyceridemia Exclusion Criteria: * HbA1c \>/=9.0%, type 1 diabetes, or history of outpatient insulin use for more than 2 weeks in the last year * Body mass index (BMI) \>40 kg/m2 * History of bariatric surgery or currently on weight loss drugs * Use of oral co...

Countries:United StatesCanada
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Frequently asked questions about ISIS apoC-III Rx

What is ISIS apoC-III Rx used for?

ISIS apoC-III Rx is an investigational small molecule being developed for the treatment of hypertriglyceridemia, a condition characterized by elevated levels of triglycerides in the blood. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does ISIS apoC-III Rx target?

ISIS apoC-III Rx is designed to target apoC-III, a protein involved in the regulation of triglyceride metabolism. By inhibiting the production of apoC-III, the drug aims to reduce triglyceride levels in patients with hypertriglyceridemia.

Who makes ISIS apoC-III Rx?

ISIS apoC-III Rx is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is ISIS apoC-III Rx in?

ISIS apoC-III Rx is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The drug is being studied for its potential to treat hypertriglyceridemia.

What clinical trials is ISIS apoC-III Rx in?

ISIS apoC-III Rx has been studied in one completed Phase 2 clinical trial with the identifier NCT01529424. This trial, titled 'Safety, Tolerability, and Pharmacokinetic Study of ISIS ApoC-III Rx in Hypertriglyceridemia,' enrolled 89 participants and was conducted in the United States and Canada.

Is ISIS apoC-III Rx the same as ISIS ApoC-III Rx?

Yes, ISIS apoC-III Rx is the same drug as ISIS ApoC-III Rx. The name is sometimes written with different capitalization or spacing, but it refers to the same investigational compound being developed by Ionis Pharmaceuticals for hypertriglyceridemia.