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ISIS-GCGRRx

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02824003Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content in Type 2 DiabetesPHASE2 COMPLETED 15Apr 1, 2016May 22, 2017May 8, 20181 Austria
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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 — 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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