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Lipid Lowering Medication

Phase 2

Hypertriglyceridemia | Small molecule | Metabolic |Grace Therapeutics, Inc.|Last Updated: Jan 8, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment289

FDA Designations

No designations recorded

Clinical trial landscape

Lipid Lowering Medication · 1 trial · 1 indication

Phase 2 1
NCT01516151Assess the Safety and Efficacy of NKPL66 (CaPre™) in the Treatment of Mild-to-high HypertriglyceridemiaHypertriglyceridemia
COMPLETED289 Analytics
PHASE2COMPLETED
Assess the Safety and Efficacy of NKPL66 (CaPre™) in the Treatment of Mild-to-high Hypertriglyceridemia
HypertriglyceridemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent change in fasting blood circulating serum TGs
Between baseline and 4 weeks of treatment.

The percent change in fasting blood circulating serum TGs between baseline and 4 weeks of treatment.

Secondary Endpoints

Absolute change in fasting plasma TGs
Baseline, Week 4 and Week 8
Patients achieving target TG fasting plasma levels
Baseline
Change in fasting plasma LDL-C, VLDL-C, HDL-C, total cholesterol, hs-CRP and non-HDL
Between baseline and 4 and 8 weeks of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group AACTIVE_COMPARATOR0.5g total CaPre™ from baseline to week 4 and 1.0g total CaPre™ from week 4 to week 8
Group BACTIVE_COMPARATOR1.0g total CaPre™ from baseline to week 4 and 2.0g total CaPre™ from week 4 to week
Group CACTIVE_COMPARATOR2.0g total CaPre™ from baseline to week 4 and 4.0g total CaPre™ from week 4 to week 8
Group DOTHERStandard of care
Group EACTIVE_COMPARATOR4.0g total CaPre™ from baseline to week 8

Interventions

NameTypeDescription
CaPre™DIETARY_SUPPLEMENT1 capsule of 0.5g total CaPre™ for 4 weeks followed by one 1.0g capsule per day for an additional 4 weeks
Lipid Lowering MedicationDRUGPatient will be treated as per the Standard of care.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: * Male and female adults aged 18 to 75 years; * Fasting plasma levels of TG \> 2.28 and \< 10 mmol/L (200 and 877 mg/dL) on two occasions within 2 weeks (screening and baseline/part 1 visits). * Patients who are currently not on pharmacotherapy for hyperlipidemia and according t...

Countries:Canada
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Frequently asked questions about Lipid Lowering Medication

What is Lipid Lowering Medication used for?

Lipid Lowering Medication is used for hypertriglyceridemia, a condition characterized by elevated levels of triglycerides in the blood. It is being developed as a small molecule treatment for this metabolic disorder. The drug is currently in clinical development and has completed a Phase 2 trial.

Who makes Lipid Lowering Medication?

Lipid Lowering Medication is being developed by Grace Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol GRCE. The drug is currently in Phase 2 clinical development for the treatment of hypertriglyceridemia.

What phase is Lipid Lowering Medication in?

Lipid Lowering Medication is in Phase 2 clinical development. It has completed one Phase 2 trial, which was an active-controlled study in patients with mild-to-high hypertriglyceridemia. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Lipid Lowering Medication in?

Lipid Lowering Medication has completed one clinical trial, identified as NCT01516151. This Phase 2 study assessed the safety and efficacy of the drug in treating mild-to-high hypertriglyceridemia. The trial enrolled 289 participants in Canada and was active-controlled, meaning it compared the drug against an active comparator.

Is Lipid Lowering Medication the same as NKPL66?

Yes, Lipid Lowering Medication is also known as NKPL66, which was referred to as CaPre in the clinical trial. The Phase 2 trial NCT01516151 evaluated NKPL66 (CaPre) for the treatment of hypertriglyceridemia. This alternative name may be used in scientific literature and clinical trial records.