DEER

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:

1.  Evaluate how safe and well tolerated DR10624 is, following single doses in healthy participants (or overweight but otherwise healthy participants).
2. Evaluate how safe and well tolerated DR10624 is, following multiple doses in healthy participants (or overweight but otherwise healthy participants).
3. 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.
4. 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.
5. Assess any effects on the fasting lipid profile, in participants receiving multiple doses of DR10624
6. Assess how the body makes antibodies against DR10624 (anti-drug antibodies) following single and multiple doses of DR10624.

It is an investigational drug because it has not been approved by MedSafe or other drug regulatory authorities.

This study (2021 FULL 11830) is being funded by Zhejiang Doer Biologics  and has been approved by the Health and Disability Ethics Committee.

Overnight stays: 5-nights (1x 3-night and 1 x 2-night) stay

Outpatient visits: 25 visits

Reimbursement: $8,500 less tax