In this clinical trial we will investigate how safe the study compound is and how well it is tolerated. The study compound is given either alone or in combination with the birth control pill or paracetamol. We will also compare the blood concentrations of the pill and paracetamol when they are given without the study compound to when they are given together with the study compound. The pill and paracetamol are approved compounds that are available in the Netherlands. The doses of the pill and paracetamol that are used in this clinical trial are safe and well tolerated.

We will also investigate how the study compound affects stomach emptying. Stomach emptying means how food moves from the stomach to the small intestine. Similar compounds are known to slow this movement. When food moves more slowly through the stomach, the absorption of compounds taken by mouth may be delayed. This can affect how they work. To understand how the study compound affects stomach emptying, we will use paracetamol. Paracetamol is not absorbed in the stomach, but it is absorbed quickly in the small intestine. This makes it useful for measuring how fast the stomach empties. We will also check whether the study compound affects how the pill is absorbed. If stomach emptying is delayed, the way the pill is absorbed may change.

We will compare the effects of the study compound with the effects of a placebo. A placebo is a compound without any active ingredient. Whether you will receive the study compound or placebo will be determined by chance.

You will be given the study compound or placebo as an injection under the skin. On the day of the study compound or placebo administration, you will receive a light breakfast. After the light breakfast, you will take the pill by mouth with water. Paracetamol is dissolved and mixed with a liquid meal.

Although the study compound is still early in development, it has been administered to overweight and obese, but otherwise healthy, people. 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 will receive a gross compensation of € 16.491,- for full participation in this trial.

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.