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ISIS 703802

Phase 2

NAFLD | Small molecule | Metabolic |Ionis Pharmaceuticals, Inc.|Last Updated: Feb 1, 2021

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment105
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03371355Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver DiseasePHASE2 COMPLETED 105 — — Dec 21, 2017Feb 24, 2020Feb 1, 202142 United States, Canada
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Study Endpoints
Primary Endpoints
Percent Change From Baseline in Fasting Triglycerides Level at the Primary Analysis Time Point
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C

An ANCOVA model was performed on the log ratio of Primary Analysis Time Point to Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of Primary Analysis Time Point to Baseline - 1) × 100.

Secondary Endpoints
Change From Baseline in Angiopoietin-Like 3 Protein at the Primary Analysis Time Point
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in TC, LDL-C, HDL-C, VLDL-C, Non-HDL-C, ApoB (ApoB-48, ApoB-100), ApoCIII, and ApoAI at the Primary Analysis Time Point
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Free Fatty Acid (FFA) at Primary Analysis Time Point
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Pooled PlaceboPLACEBO_COMPARATORParticipants from each cohort received placebo at a dose-matched volume of study drug, subcutaneously (SC).
Cohort B: ISIS 703802, 40 mg Q4WEXPERIMENTALParticipants received ISIS 703802, 40 milligrams (mg) SC once every 4 weeks for 6 doses.
Cohort C: ISIS 703802, 80 mg Q4WEXPERIMENTALParticipants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses.
Cohort A: ISIS 703802, 20 mg QWEXPERIMENTALParticipants received ISIS 703802, 20 mg once every week for 26 doses.
Interventions
NameTypeDescription
PlaceboDRUGPlacebo (Matched with ISIS 703802)
ISIS 703802 40 mgDRUGISIS 703802 40 mg, administered via SC injection, once every 4 weeks for 6 doses.
ISIS 703802 80 mgDRUGISIS 703802 80 mg, administered via SC injection, once every 4 weeks for 6 doses.
ISIS 703802 20 mgDRUGISIS 703802 20 mg, administered via SC injection, once every week for 26 doses.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites42

Key Inclusion Criteria: * Plasma triglycerides (TG) at Screening greater than (\>)150 milligrams per deciliter (mg/dL) and at qualification of \>150 mg/dL. * Documented history of hepatic steatosis with baseline magnetic resonance imaging (MRI) indicating hepatic fat fraction (HFF) greater than (\>...

Countries:United StatesCanada
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