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ISIS-PTP1BRx

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Ionis Pharmaceuticals, Inc.|Last Updated: Mar 3, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment92

FDA Designations

No designations recorded

Clinical trial landscape

ISIS-PTP1BRx · 1 trial · 2 indications

Phase 2 1
NCT01918865Safety, Tolerability, and Efficacy of ISIS-PTP1BRx in Type 2 DiabetesType 2 Diabetes Mellitus
COMPLETED92 Analytics
PHASE2COMPLETED
Safety, Tolerability, and Efficacy of ISIS-PTP1BRx in Type 2 Diabetes
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence, severity, dose-relationship of adverse effects, and changes in laboratory evaluations as a measure of safety
38 weeks
Change in plasma HbA1c levels at Week 27 compared to Baseline as a measure of efficacy
27 weeks

Secondary Endpoints

Change in FPG, weekly average SMPG, seven-point glucose profile, lipid profile, body weight, & BMI at Week 27 compared to Baseline as a measure of efficacy
27 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ISIS-PTP1BRxEXPERIMENTALWeekly Dosing for 26 Weeks
PlaceboPLACEBO_COMPARATORWeekly Dosing for 26 Weeks

Interventions

NameTypeDescription
ISIS-PTP1BRxDRUG -
PlaceboDRUG -
daily OAD (metformin and/or sulfonylurea)DRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Body mass index (BMI) \>/= 27 kg/m2 * HbA1c between 7.5% and 10.5% (inclusive) * C-Peptide (fasting) greater than or equal to 500 pmol/L * On stable dose of metformin alone or in combination with a stable dose of sulfonylurea for \>/= 3 months prior to screening, and remain on...

Countries:ArgentinaCanadaSouth Africa
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Frequently asked questions about ISIS-PTP1BRx

What is ISIS-PTP1BRx used for?

ISIS-PTP1BRx is an investigational drug being studied for the treatment of Type 2 Diabetes Mellitus. It is a small molecule being developed by Ionis Pharmaceuticals, Inc. (IONS) and is currently in Phase 2 clinical development for this metabolic condition.

What does ISIS-PTP1BRx target?

ISIS-PTP1BRx is an antisense oligonucleotide that targets PTP1B, a protein tyrosine phosphatase involved in insulin signaling. By inhibiting PTP1B, the drug aims to enhance insulin sensitivity and improve glycemic control in patients with Type 2 Diabetes Mellitus.

Who is developing ISIS-PTP1BRx?

ISIS-PTP1BRx is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the safety and efficacy of this drug in patients with Type 2 Diabetes Mellitus.

What phase is ISIS-PTP1BRx in?

ISIS-PTP1BRx is currently 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, tolerability, and efficacy in patients with Type 2 Diabetes Mellitus.

What clinical trials has ISIS-PTP1BRx been in?

ISIS-PTP1BRx has been studied in a Phase 2 clinical trial registered as NCT01918865, titled "Safety, Tolerability, and Efficacy of ISIS-PTP1BRx in Type 2 Diabetes." This randomized, double-blind, placebo-controlled trial enrolled 92 participants with Type 2 Diabetes Mellitus and obesity, and was conducted in Argentina, Canada, and South Africa.

Is ISIS-PTP1BRx the same as other PTP1B inhibitors?

ISIS-PTP1BRx is a specific antisense oligonucleotide targeting PTP1B, distinct from small-molecule PTP1B inhibitors. It is being developed by Ionis Pharmaceuticals for Type 2 Diabetes Mellitus, and its mechanism involves reducing PTP1B expression to improve insulin signaling.