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
DR10624 is being developed for the treatment of Type 2 Diabetes, obesity and a type of liver inflammation known as non-alcoholic fatty liver disease (NAFLD) or Non-alcoholic steatohepatitis (NASH).A sedentary lifestyle and excess consumption of calories drives the global obesity epidemic. There is evidence to suggest that obesity is closely associated with an increased risk of metabolic diseases such as type 2 diabetes mellitus (T2DM), dyslipidaemia (abnormal levels of fat in the blood), and NAFLD.
DR10624 is being developed as a potential treatment for some metabolic disorders, to be used in combination with a healthy diet and exercise plan. DR10624 is expected to help regulate energy balance and normalise glucose (sugar) levels in the body by potentially decreasing food intake and improving liver function.
Due to its multiple functions, DR10624 is expected to have an overall effect of lowering blood glucose and weight in patients with T2DM. DR10624 has been shown in rat models to have potential of decreasing both non-fasting and fasting blood glucose levels, reducing food intake, inhibiting body weight gain, decreasing fat mass, improving lipid profile, and liver function.
The purpose of this study is to:
- Evaluate how safe and well tolerated DR10624 is, following single doses in healthy participants (or overweight but otherwise healthy participants).
- Evaluate how safe and well tolerated DR10624 is, following multiple doses in healthy participants (or overweight but otherwise healthy participants).
- Evaluate how much of the dose and how quickly DR10624 is absorbed into the blood, and then broken down or eliminated from the body, following single and multiple doses.
- Assess the change and percentage change in body weight, body mass index (BMI), waist circumference, fasting plasma glucose (FPG), and adiponectin (hormone involved in regulation of fat) from baseline, in participants receiving multiple doses of DR10624.
- Assess any effects on the fasting lipid profile, in participants receiving multiple doses of DR10624
- Assess how the body makes antibodies against DR10624 (anti-drug antibodies) following single and multiple doses of DR10624.
Study Candidates
- Male and female
- Aged 18-70 years
- BMI 30 – 45 kg/m2
- Meet the diagnostic criteria for modest hypertriglyceridemia
What is Involved?
Overnight stays: a total of 5-nights (1x 3-night and 1 x 2-night) stay
Outpatient visits: 25 visits
Reimbursement: $NZ 8,500 less tax