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ISIS-GCGRRx- Dose Level 1

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Ionis Pharmaceuticals, Inc.|Last Updated: Jun 25, 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 Enrollment79
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02583919Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 DiabetesPHASE2 COMPLETED 79 — — Sep 1, 2015May 11, 2017Jun 25, 201819 United States
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Study Endpoints
Primary Endpoints
Change in HbA1C
Week 27 and subsequent timepoints

Change from Baseline

Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ISIS-GCGRRx - Dose Level 1EXPERIMENTALISIS-GCGRRx - Dose Level 1
ISIS-GCGRRx - Dose Level 2EXPERIMENTALISIS-GCGRRx - Dose Level 2
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
ISIS-GCGRRx- Dose Level 1DRUGonce weekly dosing for 26 weeks
ISIS-GCGRRx- Dose Level 2DRUGonce weekly dosing for 26 weeks
PlaceboDRUGonce weekly dosing for 26 weeks
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Male or female, age 18 to 75 * BMI ≥ 25.0 kg/m2 * HbA1c ≥ 8.0% and ≤ 10.5% * Type 2 Diabetes Mellitus and on stable dose of Metformin * Agree to conduct home-based (fasted) blood glucose testing as directed Exclusion Criteria: * Clinically significant abnormalities in medica...

Countries:United States
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