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DehydraTECH-CBD alone

Phase 1

Type2diabetes | Small molecule | Metabolic |Lexaria Bioscience Corp.|Last Updated: Jan 12, 2026

Target and mechanism

ModalitySmall molecule

Also known as Arm 1 - DehydraTECH-CBD alone, Arm 1- DehydraTECH-CBD alone

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment148

FDA Designations

No designations recorded

Clinical trial landscape

DehydraTECH-CBD alone · 1 trial · 1 indication

Phase 1 1
NCT06648031Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic ParticipantsType2diabetes
COMPLETED148 Analytics
PHASE1COMPLETED
Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic Participants
Type2diabetes
NCT06648031148
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Study Endpoints

Primary Endpoints

Number of participants with treatment-emergent adverse events (TEAEs) and Serious adverse events
Baseline to Day 113 post first dose administration

Secondary Endpoints

Number of participants with abnormal laboratory parameters from baseline to end of study (EOS)
Baseline to Day 113 post first dose administration
Number of participants who have a magnitude of decrease in HbA1c (1% or greater) and/or bodyweight (5% or greater) from baseline.
Baseline to Day 113 post first dose administration
Number of participants with change in fasting glucose from baseline
Baseline to Day 113 post first dose administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1 - DehydraTECH-CBD aloneEXPERIMENTAL -
Arm 2 - DehydraTECH-semaglutide aloneEXPERIMENTAL -
Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutideEXPERIMENTAL -
Arm 4 - Rybelsus medication (semaglutide) alone as a positive control.ACTIVE_COMPARATOR -
Arm 5- DehydraTECH TirzepatideEXPERIMENTAL -

Interventions

NameTypeDescription
Arm 1 - DehydraTECH-CBD aloneDRUGDose: 250 mg CBD twice daily (500 mg/day) for 12 weeks. Route of administration: Oral Dosage form: Capsule
Arm 2 - DehydraTECH-semaglutide aloneDRUGDose: 3.5 mg once daily for 4 weeks, ascending to 7 mg once daily for the remaining 8 weeks. Route of administration: Oral Dosage form: Capsule
Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutideDRUGDehydraTECH-CBD dosing = 250 mg twice daily for 12 weeks. \- DehydraTECH-semaglutide = 3.5 mg once daily for 12 weeks Route of administration: Oral Dosage form: Capsule
Arm 4 - Rybelsus medication (semaglutide) aloneDRUGNormal clinical dose of 3.0 mg once daily for 4 weeks, ascending to 7.0 mg once daily for the remaining 8 weeks. Route of administration: Oral Dosage form: Capsule
Arm 5- TirzepatideDRUGTirzepatide arm - 20mg for 4 weeks and then 40mg for 8 weeks
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion criteria: 1. Clinically diagnosed as overweight or obese, with or without pre- or Type 2 diabetes with residual islet cell function. 2. For participants with pre- or Type 2 diabetes: diet controlled or receiving oral anti-diabetic treatment (metformin or other biguanides and/or sulphonylu...

Countries:Australia
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