konjac glucomannan, wheat bran - Insulin Resistance Syndrome | Phase 2 | Unity Biotechnology, Inc. | BiopharmaWatch

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konjac glucomannan, wheat bran

Phase 2

Insulin Resistance Syndrome | 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-BlindPLACEBO_CONTROLLED

Total Trials1

Total Enrollment11

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT03741686	Effect of Konjac-mannan in Individuals With Insulin-Resistance Syndrome	PHASE2	COMPLETED	11	—	—	Jan 1, 1991	Jun 1, 1999	Nov 15, 2018	-	—

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Study Endpoints

Primary Endpoints

change in total:HDL cholesterol

change from baseline after 3 weeks, relative to control

change in fructosamine

change from baseline after 3 weeks, relative to control

change in systolic blood pressure

change from baseline after 3 weeks, relative to control

Secondary Endpoints

change in total cholesterol

change from baseline after 3 weeks, relative to control

change in LDL cholesterol

change from baseline after 3 weeks, relative to control

change in HDL cholesterol

change from baseline after 3 weeks, relative to control

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Study Design & Arms

AllocationRANDOMIZED

MaskingDOUBLE

ModelCROSSOVER

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Konjac-mannan	EXPERIMENTAL	Konjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet.
Placebo	PLACEBO_COMPARATOR	wheat bran fiber biscuits with NCEP Step II metabolically controlled diet.

Interventions

Name	Type	Description
konjac glucomannan	DIETARY_SUPPLEMENT	Konjac-mannan fiber-enriched biscuits (0.5 g/412KJ \[100kcal\] of glucommanan)
wheat bran	DIETARY_SUPPLEMENT	Wheat bran (hard red wheat bran) fiber enriched biscuits

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Eligibility Criteria

Age Range45 Years — 65 Years

SexALL

Healthy VolunteersNo

Inclusion Criteria: * Impaired glucose tolerant * Clinical absent of CHD * BMI less than 30 kg/m2 * Presence of full insulin resistance syndrome * Reduced HDL cholesterol * Elevated serum triglycerides * Moderate hypertension Exclusion Criteria: * Regular smoking * Regular alcohol consumption * F...

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