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CaPre

Phase 3

Hypertriglyceridemia | Small molecule | Other |Grace Therapeutics, Inc.|Last Updated: Aug 12, 2020

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 Trials3
Total Enrollment921
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03361501A Phase 3 STudy of CaPRe in LOwering Very hiGh TriglYcerides (TRILOGY 2)PHASE3 COMPLETED 278 — — Feb 1, 2018Jan 9, 2020Aug 12, 202068 United States, Canada +1
NCT03398005A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1)PHASE3 COMPLETED 256 — — Jan 23, 2018Nov 20, 2019Jan 18, 202069 United States
NCT01455844TRIal For Efficacy of Capre on hyperTriglyceridemiAPHASE2 COMPLETED 387 — — Sep 1, 2011Aug 1, 2014Aug 22, 201438 Canada
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Study Endpoints
Primary Endpoints
Percent change in fasting TG levels from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and 12) in patients with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L).
Week 12
Percent (%) change in triglycerides between the baseline and the 12-week assessment visit.
12 weeks
Secondary Endpoints
Percent change from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and 12) in non-HDL-C.
Week 12
Percent change from baseline (Week -1 and 0) to Week 12 (average of Week 11 and 12) in VLDL-C (β-quantification).
Week 12
Percent change from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and 12) in HDL-C.
Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CaPreEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
CaPre 1.0gEXPERIMENTAL -
CaPre 2.0gEXPERIMENTAL -
Interventions
NameTypeDescription
CaPreDRUG4 x 1 g capsules administered orally once daily for 26 weeks
PlaceboDRUG4 x 1 g capsules administered orally once daily for 26 weeks
CaPre (TM)DRUGCaPre™ 1.0g + Placebo 1.0g daily for 12 weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites68

Inclusion Criteria: 1. Subjects ≥18 years of age. 2. Isolated hypertriglyceridemia, with triglycerides ≥500 mg/dL and \<1500 mg/dL (≥5.7 mmol/L and \<17.0 mmol/L) OR Mixed hyperlipidemia, with serum triglycerides ≥500 and \<1500 mg/dL treated with a statin, CAI or PCSK9I inhibitor, alone or in comb...

Countries:United StatesCanadaMexico
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