•    The study compound is being developed for keeping weight under control therapy in adults with obesity, a disease in which excessive fat accumulates in the body, which can lead to health risks. The compound is intended to be used in combination with increased exercise and a reduced-calorie diet. 
•    In this trial, the effect of different compositions of the study compound will be assessed. The study compound will be administered as a subcutaneous injection in the abdomen. 
•    The study compound has already been administered to humans, in addition it has been extensively tested in the laboratory and in animals. 
 

Although the compound is still early in development, it has been administered to overweight and obese, but otherwise healthy, humans. Safety and tolerability of the compound were comparable with other  compounds of the same category. Participants reported gastrointestinal-related side-effects, most commonly decreased appetite. In general, these side-effects were mild. 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.
• Your weight is at least 55 kg and your Body Mass Index (BMI) is at least 23.0 and at most 35.0 kg/m2. 
• Both non-smokers and  smokers, with a maximum of 10 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 the first compound administration in this clinical trial (counting from the last compound administration).
• 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 the contraceptive pill or intra-uterine device containing hormones) in combination with a condom;
  • You are using a copper intra-uterine device in combination with a condom;
  • Your male partner has been sterilized and you are using a condom;
  • You have passed the menopause (no periods for at least 12 months)
  • You have 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 when your female partner is pregnant;
  • You have been sterilized and you are using a condom;
  • Your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
  • You are not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex.

The trial consists of 2 periods during each of which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights). Each period is followed by 4 short visits. The follow-up will take place during the final short visit.

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