Important Information
IF YOU’RE INTERESTED IN THIS STUDY:
- Please have a look at the study specific information for this trial by clicking the STUDY INFORMATION at the bottom of this page.
- You can find by clicking the VISIT PLANNERS link at the bottom of this page as well. Please note that group dates are set, so it’s important that you check your availability and let us know which groups you prefer, and whether you’re flexible for others that you can see.
- If you are interested in the study, please fill out the PRE-SCREENING FORM and include your preferred group name at the end of the form.
- From here our recruitment team will give you a call within 1-2 days to go through the study and your suitability, and, they’ll book you in for a screening appointment.
- Screening appointments for most studies need to be scheduled 2 or more weeks prior to the check in date for each group to allow enough time for your results (blood tests, etc) to come back and be reviewed by our doctors.
- If you have any questions, please don’t hesitate to reach out to us!
Study Information
TLC-3595 is being developed for the treatment of diabetes. All participants in this study meet the criteria for insulin resistance. An organ called the pancreas releases a hormone called insulin which moves around the body and acts as a key to open up cells to allow the cells to use sugar for energy. Insulin resistance is when cells do not recognise or respond to insulin, resulting in a build-up of unused sugar within the blood (high blood glucose) which can damage cells and tissues.
TLC-3595 works by inhibiting an enzyme, which increases the breakdown of fatty acids in cells in the liver, muscles, and other organs. Decreases in excess fatty acids in these cells is expected to lead to improved insulin sensitivity. It is hoped that TLC-3595 may be an effective insulin sensitiser to potentially treat insulin resistance, a significant risk factor for the development of diabetes.
The purpose of this study is to:
• Evaluate how safe and well tolerated TLC-3595 is, in participants with insulin resistance.
• Measure levels of TLC-3595 in the blood over time, following multiple oral doses, in participants with insulin resistance.
• Measure the body’s response to multiple doses of TLC-3595, in participants with insulin resistance.
This study (2022 FULL 13875) is being funded by OrsoBio, Inc and has been approved by the Health and Disability Ethics Committee.
Study Candidates
- Males or Females
- Aged 18 – 70 years
- BMI 28 kg/m2 or more
- Not taking any medications used for weight loss
- Type 2 diabetics (not using insulin)
- Have had no changes to your usual medications in the last 90 days
What is Involved?
Study Visits: 1 screening visit + 6 visits
(No inpatient stays)
Reimbursement: $2,100 (less tax)