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Viscous Fibre Blend, Psyllium, Wheat Bran

Phase 2

Lipidemia | Unknown | Metabolic |Unity Biotechnology, Inc.|Last Updated: Nov 15, 2018

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-BlindCONTROLLED
Total Trials1
Total Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03741621Viscosity of Fibre Predicts Cholesterol-lowering in Healthy IndividualsPHASE2 COMPLETED 23Jan 1, 1992Jul 1, 2010Nov 15, 2018 -
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Study Endpoints
Primary Endpoints
change in LDL cholesterol
change from baseline after 21 days, relative to control
Secondary Endpoints
change in total cholesterol
change from baseline after 21 days, relative to control
change in triglycerides
change from baseline after 21 days, relative to control
change in HDL cholesterol
change from baseline after 21 days, relative to control
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
High ViscosityEXPERIMENTALviscous fibre blend added to breakfast cereals consumed in the context of a typical North American diet for 3 weeks duration
Medium ViscosityEXPERIMENTALKellogg's Bran buds with psyllium breakfast cereal consumed in the context of a typical North American diet for 3 weeks duration
Low ViscosityEXPERIMENTALKellogg's All Bran breakfast cereal consumed in the context of a typical North American diet for 3 weeks duration
Interventions
NameTypeDescription
Viscous Fibre BlendDIETARY_SUPPLEMENTHigh viscosity viscous fiber blend sprinkled on wheat and maize bran cereals(Bran Buds®; Kellogg Company)
PsylliumDIETARY_SUPPLEMENTBran Buds cereal (white bran and maize bran) with psyllium (Bran Buds® with PSY; Kellogg Company)
Wheat BranDIETARY_SUPPLEMENTAll Bran cereal (All Bran®; Kellogg Company)
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: -healthy individuals Exclusion Criteria: * regular alcohol consumption * regular smoking

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