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CP105F

Phase 2

Hyperlipidemias | Small molecule | Metabolic |COSCIENS Biopharma Inc.|Trials Updated: Jan 16, 2024

CP105F development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Feb 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment263

FDA Designations

No designations recorded

CP105F clinical trials

CP105F · 1 trial · 1 indication

Phase 2 1
NCT03857256Compare the Efficacy and Safety of Beta-Glucan as Add-On to Statin in Subjects With Hyperlipidemia.Hyperlipidemias
COMPLETED263 Analytics
PHASE2COMPLETED
Compare the Efficacy and Safety of Beta-Glucan as Add-On to Statin in Subjects With Hyperlipidemia.
Hyperlipidemias
NCT03857256263
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Study Endpoints

Primary Endpoints

Change in Direct-measured LDL-C
week 0 to week 12

mg/dL

Secondary Endpoints

Changes in Total Cholesterol,
week 0 to week 12
Changes in Non-High-density Lipoprotein Cholesterol,
week 0 to week 12
Changes in Small Low-density Lipoprotein Subclass Particle Concentration,
week 0 to week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORmatching placebo for 12 weeks.
Oat beta-glucan 1.5gACTIVE_COMPARATORCP105F (Oat beta-glucan) 1.5g (1 tablet of 0.5g TID) for 12 weeks.
Oat beta-glucan 3g.ACTIVE_COMPARATORCP105F (Oat beta-glucan) 3g (2 tablets of 0.5g TID) for 12 weeks.
Oat beta-glucan 6g.ACTIVE_COMPARATORCP105F (Oat beta-glucan) 6g (4 tablets of 0.5g TID) for 12 weeks.

Interventions

NameTypeDescription
CP105FDRUGNatural Health Product
PlaceboDRUGtablet manufactured to mimic the CP105F beta-glucan
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Subjects must meet ALL of the following inclusion criteria in order to be eligible for this study: 1. Male or female ≥18 years of age 2. Subjects with hyperlipidemia treated with stable dose of statin for at least 6 weeks; either atorvastatin (10 mg to 20 mg daily) or equivalen...

Countries:Canada
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