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CaPre

Phase 3

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment921

FDA Designations

No designations recorded

Clinical trial landscape

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)
Hypertriglyceridemia
NCT03361501278
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PHASE3COMPLETED
A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1)
Hypertriglyceridemia
NCT03398005256
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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 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 an investigational small molecule being developed for hypertriglyceridemia, a condition of elevated triglycerides in the blood. It is a Phase 3 drug candidate studied in patients with very high triglycerides. CaPre is not yet approved and remains in clinical development.

Who makes CaPre?

CaPre is being developed by Grace Therapeutics, Inc., a biopharmaceutical company traded under the ticker GRCE. The company has conducted clinical trials of CaPre in North America for hypertriglyceridemia.

What phase is CaPre in?

CaPre is in Phase 3 clinical development for hypertriglyceridemia. It has completed three clinical trials, including two Phase 3 studies and one Phase 2 study. CaPre is investigational and has not been approved by regulatory authorities.

What clinical trials is CaPre in?

CaPre has completed three clinical trials: NCT01455844, a Phase 2 study in Canada with 387 participants; NCT03361501, a Phase 3 study in the US, Canada, and Mexico with 278 participants; and NCT03398005, a Phase 3 study in the US with 256 participants. All trials were randomized, double-blind, and placebo-controlled.

Is CaPre the same as Capre?

CaPre is also referred to as Capre in clinical trial titles and documentation. Both names refer to the same investigational drug developed by Grace Therapeutics for hypertriglyceridemia.