Type2diabetesPhase 1DehydraTECHNCT06648031
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
A Phase 1 study testing Arm 1 - DehydraTECH-CBD alone, Arm 2 - DehydraTECH-semaglutide alone and Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide in people with Type2diabetes, run by Lexaria Bioscience Corp. at 7 sites in Australia.
Trial summary
This is a Phase 1b, randomized, open-label, active-controlled, parallel, multiple-dose study comparing the safety, pharmacokinetics and efficacy of DehydraTECH Cannabidiol and Glucagon-like Peptide 1 (GLP-1) agonists alone and in combination, in overweight or obese, pre- and type 2 diabetic participants. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type2diabetes
- What is being tested?
- Arm 1 - DehydraTECH-CBD alone, Arm 2 - DehydraTECH-semaglutide alone and Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 7 sitesAustralia
- Study dates
- 4 Dec 2024to 31 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed as overweight or obese, with or without pre- or Type 2 diabetes with residual islet cell function.
- For participants with pre- or Type 2 diabetes: diet controlled or receiving oral anti-diabetic treatment (metformin or other biguanides and/or sulphonylureas) who have received a stable dose for at least 3 months prior to enrollment.
- Glycosylated haemoglobin levels of > 4.5 but ≤ 10%.
- Have a BMI at Screening of ≥ 27.00 kg/m2 and ≤ 40 kg/m2 .
- Willing to maintain a stable dose of oral anti-diabetic and/or lipid-lowering agents/medications that may have an effect on plasma glucose, insulin or lipid parameters for the duration of the study, where applicable.
- No changes in diet for 4 weeks prior to randomisation (in the opinion of PI or designee), and willing to fast overnight prior to morning dosing during the course of the study. Willing to follow the recommendations for meals and water consumption around the time of each dose administration for the duration of the study (as defined in Section 7.3.3).
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- 18 to 65 years of age (inclusive at the time of informed consent).
- Clinical laboratory values within normal range or as expected for the patient population or deemed not clinically significant (CS) by the PI or designee. One repeat test at Screening is acceptable for out-of-range CS values following approval by the PI or designee.
- Estimated glomerular filtration rate (eGFR) within the normal range, using the 2021 CKD-EPI equation (> 60 mL / min / 1.73 m2).
- Females must not be pregnant, planning pregnancy, or lactating, and must use acceptable, highly effective double contraception from Screening until 125 days after the last dose of IP administration. Effective forms of contraception are defined in Section 7.3.2. Females with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day 1 and be willing to have additional pregnancy tests as required throughout the study. Women not of childbearing potential must be postmenopausal for ≥12 months (postmenopausal status is to be confirmed through testing of follicle stimulating hormone (FSH) levels ≥ 40 IU/L at Screening for amenorrhoeic female participants). Females must not donate ova from the first dose of IP until at least 125 days after the last dose of IP.
- Males must be surgically sterile (> 30 days since vasectomy with no viable sperm), or if engaged in sexual relations with a WOCBP, either his partner must be surgically sterile (eg, tubal ligation, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or an acceptable, highly effective contraceptive method (see Section 7.3.2) must be used from Screening until study completion, including the Follow-up period. Males with same-sex partners (abstinence from penile-vaginal intercourse) or are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Males must not donate sperm from the first dose of IP until at least 125 days after the last dose of IP.
- Able and willing to attend the necessary visits to the study site and undertake all assessments.
- Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
Who cannot join
- A participant who meets any of the following exclusion criteria must be excluded from the study:
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
- Participants with a history of, or currently undergoing treatment for, a thyroid disorder. Participants may still be eligible if they have an additional test confirming that TSH levels are within the normal range (at the discretion of the PI).
- Participant is taking insulin (ie, they are insulin-dependent).
- Taking the following categories of medicines: fibrates, Thiazolidinediones, therapeutic Omega-3 fatty acids (more than 4000 mg/day), alpha-glucosidase inhibitors and unwilling to abstain 2 weeks prior to dosing and for the duration of the study.
- Currently taking a lipid lowering agent and a stable dose has not been maintained for at least 4 weeks prior to randomisation.
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- Use of anti-obesity medication within 90 days before enrollment.
- Currently receiving a prohibited medication (Section 7.3.1) and unwilling to stop at the Screening visit and for the duration of the study.
- Currently using an anti-hypertensive, with the exception of anti-hypertensives that are not relevant CYP450 inhibitors/inducers (listed in Table 2).
- Medications that are not on a stable dose, directly prohibited per the protocol and mentioned in IBs as posing a risk for causing Drug-Drug-Interactions (DDIs) taken without the Investigator's review and approval. However, in case of concerns, the Investigator should consult with the Medical Monitor.
- Vaccination with a live vaccine within 2 weeks prior to the first administration of IP.
- Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical study) within 4 months prior to Screening or 5-half lives, whichever is longer.
- Use of any IP or investigational medical device within 30 days prior to Screening, or 5 half lives of the product (whichever is the longest) or participation in more than 4 investigational drug studies within 1 year prior to Screening.
- Currently using or has used recreational cannabis, medicinal cannabis, cannabinoid medications (including Sativex®), or synthetic cannabinoid based medications within 30 days prior to study entry and unwilling to abstain for the duration for the study.
- Current smoker, including cannabis user, and must not have used any tobacco or cannabis products within 30 days prior to Screening and unwilling to abstain for the duration for the study.
- Positive toxicology screening panel (urine test including qualitative identification of barbiturates, tetrahydrocannabinol [THC], amphetamines, benzodiazepines, opiates, and cocaine), or alcohol breath test, except where a participant has a prescription and diagnosis (eg. ADHD on dexamphetamine, or opioids following an operation, etc.).
- Known or suspected history of substance abuse or dependency or history of recreational intravenous (IV) drug use over the last 5 years (by self-declaration).
- Regular alcohol consumption defined as > 10 standard drinks per week (where 1 standard drink = 360 mL of beer, 45 mL of 40% spirit or a 150 mL glass of wine) or > 4 standard drinks on any single day. Participant is unwilling to abstain from alcohol beginning 48 hours prior to Screening, the first administration of IP, and each subsequent visit.
- A history of chronic pancreatitis, and/or acute pancreatitis within 180 days before randomisation.
- Previous surgical obesity treatment (Cosmetic Surgery e.g. Liposuction allowed).
- Any known or suspected history of epilepsy or recurrent seizures.
- Diagnosis of a depressive disorder, regardless of severity, if antidepressants are currently being taken or have been used within 3 months prior to randomization. Exceptions include the use of antidepressants for non-depressive disorders (e.g., anxiety), provided a stable dose is maintained during the study. A diagnosis of depression without the use of antidepressants is not exclusionary.
- Participant who has significant history of anxiety, suicidal ideation or self-harm and had to be institutionalised, or who appears to be unstable, in the opinion of the PI or designee.
- Clinically significant cardiac, renal or hepatic impairment in the opinion of the PI or designee. For hepatic impairment, specifically excluding participants who have moderate (Child-Pugh B) or severe (Child-Pugh C) liver disease.
- Genetic dyslipidemic condition in the opinion of the PI or designee.
- Participants who would otherwise be eligible by BMI, but by subjective visual assessment are considered likely to have high muscle and low fat body composition (eg, body builders or strength sport athletes) in the opinion of the PI or designee.
- Body weight > 150 kg..
- Any abnormalities identified during the physical exam that in the opinion of the PI or designee, would prevent the participant from safe participation in the study.
- Blood donation or significant blood loss within 60 days prior to the first administration of IP, or plasma donation within 7 days prior to the first administration of IP, and/or unwilling to abstain from donation of blood during the study.
- History of severe allergic or anaphylactic reactions that in the opinion of the PI or designee might prevent the participant from safely participating in the study, or sensitivity to the IP or its constituents.
- History of malignancy, unless cured more than 5 years prior to Screening (non-melanoma skin cancer excised more than 2 years prior to Screening, and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening, are permissible).
- History or presence of a condition associated with significant immunosuppression.
- History of life-threatening infection (eg, meningitis) within the past 5 years which may indicate risk to the participant at the discretion of the Investigator.
- Infections requiring parenteral antibiotics within 6 months prior to Screening.
- Fever (body temperature > 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening.
- Systolic blood pressure of <100 mmHg or ≥180 mmHg and/or diastolic blood pressure of <80 mmHg or ≥120 mmHg, which in the opinion of the PI or designee may pose undue risk to the subject, or symptomatic uncontrolled hypotension or hypertension in the opinion of the PI or designee.
- Moderate to severe daytime somnolence or daytime sleep disorders (e.g., narcolepsy).
- Abnormal ECG findings at Screening that are considered by the PI or designee to be clinically significant.
- Alkaline phosphatase (ALP), aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT) > 1.5 × upper limit of normal (ULN) at Screening. One repeat test at Screening is acceptable for out-of-range values following approval by the PI or designee.
- Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.
- Poor pill swallowing ability.
- Unwilling to refrain from strenuous exercise (including weightlifting) from 24 hours prior to each visit to the study site until the end of each visit.
- Travel outside the country of residence planned during the study.
- Any other significant disease or disorder, physical or psychological, or surgery (within the past 3 months prior to Screening) which, in the opinion of PI or designee, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to comply with the protocol or complete the study per protocol.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Australia7 sites
CMAX Clinical Research
Adelaide, South Australia, 5000
Paratus Clinical Pty Ltd, Blacktown Trial Clinic
Blacktown, New South Wales, 2148
Emeritus - Sydney
Botany, New South Wales, 2019
Emeritus - Melbourne
Camberwell, Victoria, 3124
Paratus Clinical Brisbane Pty Ltd
Herston, Queensland, 4006
Canopy Clinical Sutherland
Miranda, New South Wales, 2228
Canopy Clinical Wollongong
Wollongong, New South Wales, 2500
About this study
Official title: A Phase 1B, Randomized, Open-label, Active-controlled, Parallel, Multiple-dose Study Comparing the Safety, Pharmacokinetics and Efficacy of Dehydratech Cannabidiol and Glucagon-like Peptide 1 Agonists Alone and in Combination, in Overweight or Obese, pre-and Type 2 Diabetic Participants.
This is a Phase 1b, randomized, open-label, active-controlled, parallel, multiple-dose study comparing the safety, pharmacokinetics and efficacy of DehydraTECH Cannabidiol and Glucagon-like Peptide 1 (GLP-1) agonists alone and in combination, in overweight or obese, pre- and type 2 diabetic participants.
Read the detailed description
The study duration is for a maximum study duration of 20 weeks and 6 days. All participants will be randomized to receive one of the 4 interventions- Arm 1- DehydraTECH-CBD alone; Arm2- DehydraTECH-semaglutide alone; Arm-3 DehydraTECH-CBD in combination with DehydraTECH-semaglutide or Arm 4 - Rybelsus medication (semaglutide) alone as a positive control. Arm 5- DehydraTECH Tirzepatide
Treatment period visits include safety assessments, including vital signs and physical examinations (symptom directed), as well as Patient reported outcome (PRO) questionnaires, body mass measures and a 15 to 20 mL blood sample.
- Conditions
- Type2diabetes
- Being tested
- Arm 1 - DehydraTECH-CBD alone, Arm 2 - DehydraTECH-semaglutide alone, Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide, Arm 4 - Rybelsus medication (semaglutide) alone, Arm 5- Tirzepatide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 - DehydraTECH-CBD aloneDrug
Dose: 250 mg CBD twice daily (500 mg/day) for 12 weeks. Route of administration: Oral Dosage form: Capsule
Arm 2 - DehydraTECH-semaglutide aloneDrug
Dose: 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-semaglutideDrug
DehydraTECH-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) aloneDrug
Normal 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- TirzepatideDrug
Tirzepatide arm - 20mg for 4 weeks and then 40mg for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - DehydraTECH-CBD alone | Experimental | Not described Receives: Drug: Arm 1 - DehydraTECH-CBD alone |
| Arm 2 - DehydraTECH-semaglutide alone | Experimental | Not described Receives: Drug: Arm 2 - DehydraTECH-semaglutide alone |
| Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide | Experimental | Not described Receives: Drug: Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide |
| Arm 4 - Rybelsus medication (semaglutide) alone as a positive control. | Active comparator | Not described Receives: Drug: Arm 4 - Rybelsus medication (semaglutide) alone |
| Arm 5- DehydraTECH Tirzepatide | Experimental | Not described Receives: Drug: Arm 5- Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs) and Serious adverse events
Measured: Baseline to Day 113 post first dose administration
Secondary outcomes (7)
Number of participants with abnormal laboratory parameters from baseline to end of study (EOS)
Measured: 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.
Measured: Baseline to Day 113 post first dose administration
Number of participants with change in fasting glucose from baseline
Measured: Baseline to Day 113 post first dose administration
Number of participants with change in insulin cholesterol levels from baseline
Measured: Baseline to Day 113 post first dose administration
Number of participants with change in inflammation (hsCRP)from baseline
Measured: Baseline to Day 113 post first dose administration
Number of participants with change in estimated glomerular filtration rate from baseline
Measured: Baseline to Day 113 post first dose administration
Number of participants with change in liver enzymes from baseline
Measured: Baseline to Day 113 post first dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start4 Dec 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexaria Bioscience Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648031
- Sponsor's protocol ID
- GLP-1-H24-4
- Acronym
- DehydraTECH
- Status last verified
- Jan 2026
- First submitted
- 16 Oct 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B, Randomized, Open-label, Active-controlled, Parallel, Multiple-dose Study Comparing the Safety, Pharmacokinetics and Efficacy of Dehydratech Cannabidiol and Glucagon-like Peptide 1 Agonists Alone and in Combination, in Overweight or Obese, pre-and Type 2 Diabetic Participants.
- ClinicalTrials.gov ID
- NCT06648031
- Acronym / sponsor ID
- DehydraTECH / GLP-1-H24-4
- Conditions
- Type2diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Lexaria Bioscience Corp.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1b, randomized, open-label, active-controlled, parallel, multiple-dose study comparing the safety, pharmacokinetics and efficacy of DehydraTECH Cannabidiol and Glucagon-like Peptide 1 (GLP-1) agonists alone and in combination, in overweight or obese, pre- and type 2 diabetic participants.
Detailed description
The study duration is for a maximum study duration of 20 weeks and 6 days. All participants will be randomized to receive one of the 4 interventions- Arm 1- DehydraTECH-CBD alone; Arm2- DehydraTECH-semaglutide alone; Arm-3 DehydraTECH-CBD in combination with DehydraTECH-semaglutide or Arm 4 - Rybelsus medication (semaglutide) alone as a positive control. Arm 5- DehydraTECH Tirzepatide
Treatment period visits include safety assessments, including vital signs and physical examinations (symptom directed), as well as Patient reported outcome (PRO) questionnaires, body mass measures and a 15 to 20 mL blood sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - DehydraTECH-CBD alone | Experimental | Drug: Arm 1 - DehydraTECH-CBD alone |
| Arm 2 - DehydraTECH-semaglutide alone | Experimental | Drug: Arm 2 - DehydraTECH-semaglutide alone |
| Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide | Experimental | Drug: Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide |
| Arm 4 - Rybelsus medication (semaglutide) alone as a positive control. | Active comparator | Drug: Arm 4 - Rybelsus medication (semaglutide) alone |
| Arm 5- DehydraTECH Tirzepatide | Experimental | Drug: Arm 5- Tirzepatide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Clinically diagnosed as overweight or obese, with or without pre- or Type 2 diabetes with residual islet cell function.
- For participants with pre- or Type 2 diabetes: diet controlled or receiving oral anti-diabetic treatment (metformin or other biguanides and/or sulphonylureas) who have received a stable dose for at least 3 months prior to enrollment.
- Glycosylated haemoglobin levels of > 4.5 but ≤ 10%.
- Have a BMI at Screening of ≥ 27.00 kg/m2 and ≤ 40 kg/m2 .
- Willing to maintain a stable dose of oral anti-diabetic and/or lipid-lowering agents/medications that may have an effect on plasma glucose, insulin or lipid parameters for the duration of the study, where applicable.
Key exclusion criteria (44 listed)
- A participant who meets any of the following exclusion criteria must be excluded from the study:
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
- Participants with a history of, or currently undergoing treatment for, a thyroid disorder. Participants may still be eligible if they have an additional test confirming that TSH levels are within the normal range (at the discretion of the PI).
- Participant is taking insulin (ie, they are insulin-dependent).
- Taking the following categories of medicines: fibrates, Thiazolidinediones, therapeutic Omega-3 fatty acids (more than 4000 mg/day), alpha-glucosidase inhibitors and unwilling to abstain 2 weeks prior to dosing and for the duration of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1 - DehydraTECH-CBD aloneDose: 250 mg CBD twice daily (500 mg/day) for 12 weeks. Route of administration: Oral Dosage form: Capsule | Drug | Arm 1 - DehydraTECH-CBD alone |
| Arm 2 - DehydraTECH-semaglutide aloneDose: 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 | Drug | Arm 2 - DehydraTECH-semaglutide alone |
| Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutideDehydraTECH-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 | Drug | Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide |
| Arm 4 - Rybelsus medication (semaglutide) aloneNormal 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 | Drug | Arm 4 - Rybelsus medication (semaglutide) alone as a positive control. |
| Arm 5- TirzepatideTirzepatide arm - 20mg for 4 weeks and then 40mg for 8 weeks | Drug | Arm 5- DehydraTECH Tirzepatide |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs) and Serious adverse events
Time frame: Baseline to Day 113 post first dose administration
7 secondary outcomes
Number of participants with abnormal laboratory parameters from baseline to end of study (EOS)
Time frame: 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.
Time frame: Baseline to Day 113 post first dose administration
Number of participants with change in fasting glucose from baseline
Time frame: Baseline to Day 113 post first dose administration
Number of participants with change in insulin cholesterol levels from baseline
Time frame: Baseline to Day 113 post first dose administration
Number of participants with change in inflammation (hsCRP)from baseline
Time frame: Baseline to Day 113 post first dose administration
Number of participants with change in estimated glomerular filtration rate from baseline
Time frame: Baseline to Day 113 post first dose administration
Number of participants with change in liver enzymes from baseline
Time frame: Baseline to Day 113 post first dose administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Arm 1 - DehydraTECH-CBD alone, Arm 2 - DehydraTECH-semaglutide alone and Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide in people with Type2diabetes, run by Lexaria Bioscience Corp. at 7 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs) and Serious adverse events (time frame: Baseline to Day 113 post first dose administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.