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

What Was Tested

In this phase 1 trial, researchers set out to test Tirzepatide and Semaglutide.

It had five arms (groups): Arm 1 - DehydraTECH-CBD alone (experimental), Arm 2 - DehydraTECH-semaglutide alone (experimental), Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide (experimental), Arm 4 - Rybelsus medication (semaglutide) alone as a positive control. (active comparator) and Arm 5- DehydraTECH Tirzepatide (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 148 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Clinically diagnosed as overweight or obese, with or without pre- or Type 2 diabetes with residual islet cell function. Have a BMI at Screening of ≥ 27.00 kg/m2 and ≤ 40 kg/m2 . 18 to 65 years of age (inclusive at the time of informed consent). 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.

The full record lists 13 inclusion and 43 exclusion criteria; among the exclusions: personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2); participant is taking insulin (ie, they are insulin-dependent); use of anti-obesity medication within 90 days before enrollment.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Tirzepatide study: the participants and staff both knew the treatment.

It started in 2024-12-04 with completion listed for 2025-07-31.

It ran at 7 sites in Australia (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of participants with treatment-emergent adverse events (TEAEs) and Serious adverse events.

It also tracked 7 secondary outcomes, for example Number of participants with abnormal laboratory parameters from baseline to end of study (EOS), Number of participants with change in fasting glucose from baseline, Number of participants with change in insulin cholesterol levels from baseline, Number of participants with change in inflammation (hsCRP)from baseline, Number of participants with change in estimated glomerular filtration rate from baseline and Number of participants with change in liver enzymes from baseline.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide and Semaglutide in 148 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page and the Semaglutide compound page, all human trials.