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BW4BIY33-0H1WE9-B

Obesity

  • M/F
  • 18 - 55 years old
  • Healthy

Clinical trial of a new compound that is being developed for the treatment of obesity and a fatty, inflamed liver

  • From August 2025
  • 33 days (Spread over several periods)
  • 4 visits

€9008,-

Friendly employees, nice co-participants and good food! 

 

Marjan

Deelnemer ICON

Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 18 and 55 years old
  • You weigh more than 50 kg
  • Your Body Mass Index (BMI) is between 25 and 29.9 kg/m2

Good to know about this trial

  • The study compound is known to inhibit a particular molecule which can result in weight loss, and reduce and prevent the development of a fatty, inflamed liver.
  • The study compound has not been administered to humans before. It has been extensively tested in the laboratory and on animals.
  • As a woman, you may only participate in this study if you have gone through menopause (no menstruation for at least 12 months) or have been sterilized.

Please note: participation is only possible when you have a BMI between 30.0 and 34.9

Download the complete research overview

Wie funktioniert es

Wie funktioniert es?

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Study groups

Register without obligation for the group of your preference

THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH

Additional information

The study compound is known to inhibit a particular molecule which can result in weight loss, and reduce and prevent the development of a fatty, inflamed liver.

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.

The study compound has not been administered to humans before. It has been extensively tested in the laboratory and on animals.

WHO CAN PARTICIPATE?

Target group

  • 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.

WHAT IS THE COMPENSATION FOR THIS RESEARCH?

Compensation

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.

How long does this research take?

Period of stay and research

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 will take place during the last short visit.

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website. The location in Groningen is Van Swietenlaan 6.

More information about the study

More information

Soon a clinical trial will start at ICON with a new compound being developed for the treatment of obesity and a fatty, inflamed liver. The study compound is known to inhibit a particular molecule which can result in weight loss, and reduce and prevent the development of a fatty, inflamed liver.

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