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CaPre

Phase 3

Hypertriglyceridemia | Small molecule | Metabolic |Grace Therapeutics, Inc.|Trials Updated: Aug 12, 2020

CaPre development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Dec 2017

CaPre target and mechanism

ModalitySmall molecule

Also known as CaPre (TM)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment921

FDA Designations

No designations recorded

CaPre clinical trials

CaPre · 3 trials · 1 indication

Phase 3 2Phase 2 1
NCT03361501A Phase 3 STudy of CaPRe in LOwering Very hiGh TriglYcerides (TRILOGY 2)Hypertriglyceridemia
COMPLETED278 Analytics
NCT03398005A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1)Hypertriglyceridemia
COMPLETED256 Analytics
PHASE3COMPLETED
A Phase 3 STudy of CaPRe in LOwering Very hiGh TriglYcerides (TRILOGY 2)
HypertriglyceridemiaUnlock trial analytics
PHASE3COMPLETED
A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1)
HypertriglyceridemiaUnlock trial analytics

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 to 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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Frequently asked questions about CaPre

What is CaPre used for?

CaPre is being developed for the treatment of hypertriglyceridemia, a metabolic condition marked by elevated triglyceride levels. It is an investigational small molecule studied in adults 18 years and older. CaPre has not been approved for commercial use and remains in clinical development.

Who is developing CaPre?

CaPre is being developed by Grace Therapeutics, Inc., which trades under the ticker GRCE. The company has sponsored the clinical program evaluating CaPre in hypertriglyceridemia, including the Phase 3 TRILOGY 1 and TRILOGY 2 studies and an earlier Phase 2 trial.

What phase is CaPre in?

CaPre is in Phase 3 development for hypertriglyceridemia. Three trials have been completed: two Phase 3 studies, TRILOGY 1 and TRILOGY 2, and one Phase 2 study. No trials are currently active. CaPre is investigational and has not been approved by the FDA.

What clinical trials is CaPre in?

CaPre has been evaluated in three completed trials: NCT03398005 (TRILOGY 1), a Phase 3 study conducted in the United States; NCT03361501 (TRILOGY 2), a Phase 3 study run in the United States, Canada, and Mexico; and NCT01455844, a Phase 2 trial conducted in Canada. Total enrollment across these studies was 921 participants.

Is CaPre the same as CaPre (TM)?

Yes, CaPre and CaPre (TM) refer to the same investigational drug candidate. CaPre (TM) is the trademarked form of the name used by Grace Therapeutics, Inc. for its small molecule being developed to treat hypertriglyceridemia.