In this study we will investigate how safe the study compound is and how well it is tolerated when it is used by healthy people. We will also investigate how effective it might be when it is used by overweight and moderately obese but otherwise healthy subjects. Furthermore, we also investigate how quickly and to what extent the compound is absorbed, transported (the transport of the drug through the blood and tissue), and eliminated (the removal of drugs) from the body. In addition, we look at the effect of the compound on body weight and glucose levels in blood. We compare the effects of the compound with the effects of a placebo. A placebo is a compound without any active ingredient.

The study consists of two parts: Part A and Part B. You can only participate in one group of one part. In both parts you will be given the compound or placebo as an injection under the skin (subcutaneous). Whether you will receive the compound or placebo will be determined by chance. In Part A you will receive the compound once. In Part B, you will receive the compound once a week for 4 weeks.

This trial is not intended to improve your health but is necessary for the further development of this compound. The trial will only take place after it has been approved by the Central Committee on Research Involving Human Subjects (CCMO).

You will receive a gross compensation of € 8692 for full participation in group B1 or B2 of Part B. You will receive a gross compensation of € 9008 for full participation in group B3 or B4 of Part B.

Travel expenses will be reimbursed based on the distance traveled (€ 0.23 per kilometer) with a minimum of € 14.23 and a maximum of € 193.20 (840 kilometers) per round trip, regardless of the mode of transportation.

• You are a healthy male or female.
• You are at least 18 and no more than 55 years old.
• Part B, groups B1 and B2: You weigh at least 50 kg and your Body Mass Index (BMI) is higher than or equal to 25.0 and lower than or equal to 29.9 kg/m². The BMI shows the relationship between body weight in kilograms and height in meters.
• Part B, groups B3 and B4: You weigh at least 50 kg and your Body Mass Index (BMI) is higher than or equal to 30.0 and lower than or equal to 34.9 kg/m². The BMI shows the relationship between body weight in kilograms and height in meters.
• You did not smoke or use nicotine-containing products for the 30 days prior to the first dose.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first compound administration in this clinical trial (counting from the follow-up visit of the previous 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.

• In part B, you can only participate as a female if you meet one of the following conditions:
• You have passed the menopause (no periods for at least 12 months);
• You have been sterilized or are sterile due to other reasons.
• 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 (for example the contraceptive pill or intra-uterine device);
  • You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
  • You are only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.

All potential medicines can cause side effects. As the compound will be administered to humans for the first time in this trial, side effects in humans are not known yet. The compound has been studied extensively in the laboratory and in animals. Based on the way this study compound works, the following side effects are expected: Injection site reactions, hypersensitivity reactions, immune system responses, body weight loss, side effects of the kidney and elevated liver enzymes.

You should take into account that (serious) side effects may occur that are still unknown. In addition to unknown side effects, there is a (small) chance that an allergic reaction will occur. This can be caused by the study compound or other ingredients that are used to prepare the formulation (for example, dyes and flavors). During the study, you will be under strict medical supervision. The doctors and investigators of ICON are always well-informed about the compound being studied. With this knowledge they can estimate the effects and side effects reasonably well.

This trial will be executed  in healthy male and female participants. The trial consists of 2 parts, Part A and Part B. You can participate only once in this trial.

To check if you are eligible to participate a medical screening will take place before the start of the trial. Depending on availability, this can be performed in Groningen or Utrecht. This screening will take place within 4 weeks before the start of the clinical trial.

Part B Group B1 and B2
For group B1 and B2 the study consists of 1 period during which you will stay at the research center in Groningen for 30 days (29 nights), followed by 6 short visits. The follow-up visit will take place during the last short visit.

Part B Group B3 and B4
For group B3 and B4 the study consists of 2 periods during which you will stay the first period at the research center in Groningen for 31 days (30 nights), followed by 4 short visits. During the second period you will stay at the research center in Groningen for 2 days (1 night), followed by 1 short visit. The follow-up visit will take place during the last short visit.

In part B, you will receive the compound 4 times, once a week. You will be given the compound or placebo as an injection under the skin (subcutaneous).

During the trial, blood will regularly be drawn and urine will be collected. Prior to screening, admission, and the follow-up, you have to stay fasted for 4 hours. You can only drink water prior to your visit. This means that we will ask you to fast prior to any participation in the trial. You have not yet signed the form for participation in the trial. After the screening it will be announced whether you can participate.

Consumption of medication, alcohol, coffee and tea, cola, energy drinks and chocolate (including chocolate milk), grapefruit (including juice), poppy seeds and tobacco/nicotine-containing products are not allowed during the trial. Also, before the start of the trial and when you are not staying in the research facility, there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine (also called theine) is allowed.