The study compound may potentially be used for weight reduction in people living with (severe) overweight. The study compound is similar to a human hormone called amylin. Amylin acts naturally on the brain and increases the feeling of satiety (feeling full). As a result, you feel less inclined to eat. The study compound works in the body in the same way. Previous studies with the study compound show that it lasts longer than amylin. It therefore can potentially have an extended impact on controlling food intake and appetite.

In this trial we will investigate the effect of the study compound on heart rate and rhythm. We will also investigate how safe the study compound is, and how well it is tolerated when healthy people use it.

You will receive the study compound or placebo once weekly for 22 weeks. A placebo is a compound without any active ingredient. The study compound or placebo is given as injections into the fatty layer of tissue under the skin of the abdomen. You will administer eight of the doses to yourself at home, using an automatic injection pen (autoinjector). This is a medical device that has a needle hidden inside and gives a set amount of medicine with the push of a button. Prior to home dosing, you will receive training in how to use the autoinjector. You will learn where and when to administer the injection and what information you need to record in your diary. In addition, you will occasionally receive capsules containing an approved antibiotic (moxifloxacin) or placebo.

On several days during each period, your heart will be continuously monitored. For this, adhesive patches (electrodes) will be placed on your chest and connected to a device. At several times, you will need to lie still for 15 minutes without moving, talking or sleeping. During these moments, you also cannot listen to music, watch TV, or use a laptop or phone. Outside these moments, however, this is allowed.

• You are a healthy male or female.
• You are at least 18 and at most 55 years old.
• Your weight is at least 55 kg and your Body Mass Index (BMI) is at least 25.0 and at most 29.9 kg/m². 
• Both non-smokers and light smokers or occasional smokers (max. 7 cigarettes per week) are allowed to participate in this clinical trial. During your stay in our research facility, you are not allowed to smoke.

• 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) starting from screening;
  • You are using a copper intra-uterine device starting from screening;
  • 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 only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.
• For males, there are no requirements regarding contraception.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 90 days prior to the admission to this clinical trial (counting from the last dose in the previous trial). If you have used medication for high potassium levels, diabetes and/or weight loss in the 90 days before admission to the clinic, you also cannot participate. Please contact us for more information.
• 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.

The trial consists of 3 periods during which you will stay in the research facility in Groningen for 9 days (8 nights), 6 days (5 nights), and 7 days (6 nights).
There will be 16 short visits in total, the last of which will be the follow-up visit.

Note: You must be available for all dates to be able to participate in this clinical trial. The location in Groningen is Van Swietenlaan 6.