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ISIS-GCGRRx

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Ionis Pharmaceuticals, Inc.|Trials Updated: Jun 25, 2018

ISIS-GCGRRx development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jul 2016

ISIS-GCGRRx target and mechanism

ModalitySmall molecule

Also known as ISIS-GCGRRx- Dose Level 1, ISIS 449884

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment171

FDA Designations

No designations recorded

ISIS-GCGRRx clinical trials

ISIS-GCGRRx · 3 trials · 2 indications

Phase 2 3
NCT02824003Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content in Type 2 DiabetesType 2 Diabetes
COMPLETED15 Analytics
NCT02583919Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 DiabetesType 2 Diabetes
COMPLETED79 Analytics
NCT01885260Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 DiabetesType 2 Diabetes Mellitus
COMPLETED77 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
PHASE2COMPLETED
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 Diabetes
Type 2 DiabetesUnlock trial analytics
PHASE2COMPLETED
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes
Type 2 Diabetes MellitusUnlock 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

Change in HbA1C
Week 27 and subsequent timepoints

Change from Baseline

The effect of ISIS-GCGRRx on serum fructosamine
14 Weeks

Change from Baseline to Week 14

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
Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort
50 weeks
The safety of ISIS-GCGRRx
25 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
ISIS-GCGRRx - Dose Level 1EXPERIMENTALISIS-GCGRRx - Dose Level 1
ISIS-GCGRRx - Dose Level 2EXPERIMENTALISIS-GCGRRx - Dose Level 2
ISIS-GCGRRx Dose Level 1EXPERIMENTALISIS-GCGRRx Dose Level 1
ISIS-GCGRRx Dose Level 2EXPERIMENTALISIS-GCGRRx Dose Level 2

Interventions

NameTypeDescription
ISIS-GCGRRxDRUGonce weekly dosing for 13 weeks
PlaceboDRUGonce weekly dosing for 13 weeks
ISIS-GCGRRx- Dose Level 1DRUGonce weekly dosing for 26 weeks
ISIS-GCGRRx- Dose Level 2DRUGonce weekly dosing for 26 weeks
ISIS-GCGRRx - Dose Level 1DRUG3 doses on alternate days during the first week and then once weekly for 12 weeks
ISIS-GCGRRx - Dose Level 2DRUG3 doses on alternate days during the first week and then once weekly for 12 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:AustriaUnited StatesSouth Africa
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Frequently asked questions about ISIS-GCGRRx

What is ISIS-GCGRRx used for?

ISIS-GCGRRx is an investigational drug being developed for the treatment of Type 2 Diabetes and Type 2 Diabetes Mellitus. It has been studied in Phase 2 clinical trials to evaluate its safety, tolerability, and efficacy in patients with these conditions.

Who is developing ISIS-GCGRRx?

ISIS-GCGRRx is being developed by Ionis Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol IONS. Ionis is a biopharmaceutical company focused on discovering and developing RNA-targeted therapeutics.

What phase is ISIS-GCGRRx in?

ISIS-GCGRRx is in Phase 2 clinical development. It has completed two Phase 2 trials, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.

What clinical trials is ISIS-GCGRRx in?

ISIS-GCGRRx has been evaluated in completed Phase 2 trials, including NCT02824003, which studied its effect on hepatic lipid and glycogen content in Type 2 Diabetes, and NCT02583919, which assessed its safety, tolerability, and efficacy in patients with Type 2 Diabetes.

Is ISIS-GCGRRx the same as ISIS-GCGRRx - Dose Level 1?

ISIS-GCGRRx - Dose Level 1 is an alternative name for ISIS-GCGRRx, referring to a specific dose level used in clinical trials. Both names refer to the same investigational drug candidate being developed by Ionis Pharmaceuticals for Type 2 Diabetes.