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ISIS-GCGRRx

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Ionis Pharmaceuticals, Inc.|Last Updated: May 8, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

ISIS-GCGRRx · 1 trial · 1 indication

Phase 2 1
NCT02824003Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content in Type 2 DiabetesType 2 Diabetes
COMPLETED15 Analytics
PHASE2COMPLETED
Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content in Type 2 Diabetes
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in fasting hepatic glycogen content
Week 14

Change from Baseline

Change in fasting hepatic lipid content
Week 14

Change from Baseline

Secondary Endpoints

Safety and Tolerability will be assessed by determining the incidence, severity, dose relationship of adverse effects, and changes in laboratory evaluations
38 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ISIS-GCGRRxEXPERIMENTALISIS-GCGRRx once weekly dosing for 13 weeks
PlaceboPLACEBO_COMPARATORonce weekly dosing for 13 weeks

Interventions

NameTypeDescription
ISIS-GCGRRxDRUGonce weekly dosing for 13 weeks
PlaceboDRUGonce weekly dosing for 13 weeks
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female, age 18 to 75 * BMI ≥ 25.0 kg/m2 \< 36.0 kg/m2 * HbA1c ≥ 7.5% and ≤ 10.5% * Type 2 Diabetes Mellitus and on stable dose of Metformin. Patients must have been on a stable dose of oral metformin (at least 1000 mg/day) for a minimum of 3 months prior to screening e...

Countries:Austria
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Frequently asked questions about ISIS-GCGRRx

What is ISIS-GCGRRx used for?

ISIS-GCGRRx is an investigational drug being studied for the treatment of Type 2 Diabetes. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its effects on hepatic lipid and glycogen content in patients with Type 2 Diabetes.

Who makes ISIS-GCGRRx?

ISIS-GCGRRx is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company. Ionis Pharmaceuticals is listed on the stock exchange 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-GCGRRx in?

ISIS-GCGRRx is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for its potential use in treating Type 2 Diabetes, and its safety and efficacy have not yet been established.

What clinical trials is ISIS-GCGRRx in?

ISIS-GCGRRx has one completed Phase 2 clinical trial registered under the identifier NCT02824003. This study, titled 'Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content in Type 2 Diabetes,' was conducted in Austria with 15 participants. The trial was randomized, double-blind, and placebo-controlled.

Is ISIS-GCGRRx the same as another drug?

ISIS-GCGRRx is the specific name of the investigational drug being developed by Ionis Pharmaceuticals. No alternative names for this drug have been disclosed in the available information. It is important to note that ISIS-GCGRRx is distinct from other drugs and should not be confused with them.