• The study compound is being developed for the treatment of type 2 diabetes and weight control by lowering blood sugar levels. People with type 2 diabetes have too much sugar in their blood and need treatment to control their sugar levels. The study compound acts like a hormone that occurs naturally in the body, this hormone helps people feel full and helps to lower blood sugar levels. Some medications that act this way are already approved and being used to treat people living with diabetes and for weight control. The study compound can be administered more easily than these medications, because these medications are administered with an injection under the skin while the study compound can be given by mouth.
• In this study we will investigate how safe and well-tolerated the study compound is. Additionally, we will measure the effect of the study compound on how the body processes two different approved medications. Blood values of previously approved medications (Rosuvastatin and Pitavastatin) will be measured when they are given alone. Then it is compared to when they are given together with the study compound.
• The approved medications that you will receive in this study are Rosuvastatin and Pitavastatin, both of these medications are used for treatment of high cholesterol. Cholesterol is a building block for cells and hormones, but elevated cholesterol levels increase the risk of cardiovascular diseases. The dosages of both medications that are used in this study have been shown to be safe and well tolerated.
• During the study, your heart will be monitored continuously 6 times over a 24-hour period. For this, adhesive patches (electrodes) will be placed on your chest and connected to a small device. At various times, you will need to lie still for 15 minutes without moving, talking, or sleeping. During these periods, you also cannot listen to music, watch TV, or use a laptop or phone. However, you are allowed to engage in these activities outside of these 15-minute periods.

The compound has been extensively tested in the laboratory and in animals, and has been administered before in healthy individuals and patients with type 2 diabetes. In these clinical trials, the following side-effects were observed most often: nausea, vomiting and diarrhea. These side effects were mostly of mild intensity. You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects. This information will also be discussed with you at the start of the medical screening. You can then ask questions to the screening physician or nurse. Once everything is clear to you, you can decide to give written consent to participate in the trial. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.

• You are a healthy male or female.
• You are at least 18 and at most 65 years old.
• You are not of Asian heritage. Based on studies it is known that people of Asian heritage respond more strongly to Rosuvastatin than people of other heritage. Asian participants would therefore be at risk of being exposed to significantly higher Rosuvastatin levels in the blood.
• Your Body Mass Index (BMI) is at least 27.0 kg/m2. 
• You have had a relatively stable body weight in the two months prior to screening (no major fluctuations in body weight);
• Both non-smokers and light smokers, with a maximum of 5 cigarettes per day, are allowed to participate in this clinical trial. During your stay in our research facility, you are not allowed to smoke.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 90 days prior to admission to the clinic in this clinical trial (counting from the follow-up visit).
• For this trial, you cannot (have) receive(d) a vaccine from 4 weeks prior to the start until the end of the trial.
• To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.

• As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
  • You are using hormonal contraception (for example an intra-uterine device containing hormones) in combination with a condom; Please note: hormonal contraception taken by mouth (for example the contraceptive pil) is not allowed in this trial.
  • You are using a copper intra-uterine device in combination with a condom;
  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized or your male partner has been sterilized;
  • You are not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex.
• As a male you can only participate if you meet one of the following conditions:
  • You are using a condom in combination with an additional contraception method used by your female partner;
  • You are using a condom and have been sterilized;
  • You are using a condom and your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
  • You are using a condom if your female partner is pregnant;
  • You are not sexually active according to your lifestyle;
  • You are using a condom and are only sexually active with a partner of the same sex.

The trial consists of 2 periods during which you will stay in our research facility in Groningen (location van Swietenlaan 6). In period 1 you will stay for 13 days (12 nights), in period 2 you will stay for a maximum of 47 days (46 nights). Depending on how you respond to the study compound the second period of stay could also be shorter than 47 days. Between period 1 and 2 there will be a 14 day period during which you will take the study medication at home. During these 14 days there will also be 3 short visits to the clinic during which you will receive the medication needed for the coming days. The follow-up visit will take place approximately 21 days after your last departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial.