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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 April 2025
  • 30 days
  • 5 visits

€8456,-

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 34.9 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.

 

How does it work

How does it work?

Read more

Study groups

Register without obligation for the group of your preference

THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH

Additional information

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.

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 A: You weigh at least 50 kg and your Body Mass Index (BMI) is higher than or equal to 20.0 and lower than or equal to 24.9 kg/m2. The BMI shows the relationship between body weight in kilograms and height in meters.
  • Part B, groups 1 to 3: 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, group 4: 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 A, you can only participate as a female if you are not pregnant, not breastfeeding 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;
    • 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.
  • 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 one of the groups of Part B.

Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (840 kilometers) per round trip, regardless of the mode of transportation.

How long does this research take?

Period of stay and research

Part B 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.

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.

Veelgestelde vragen

Je mag maximaal 4 keer per jaar deelnemen aan een onderzoek. Tussen twee onderzoeken moeten minstens 30 dagen zitten. Voor sommige onderzoeken geldt een langere wachttijd.

 

Je kunt tijdens het onderzoek last krijgen van bijwerkingen. Voordat een geneesmiddel op mensen mag worden getest, is het al uitgebreid onderzocht in een laboratorium. Daardoor kunnen we goed voorspellen welke bijwerkingen je eventueel kunt krijgen en kunnen we je daarop voorbereiden. Het komt dus bijna nooit voor dat deelnemers last krijgen van onverwachte bijwerkingen. Een allergische reactie op het middel komt gemiddeld bijvoorbeeld één keer per jaar voor.

Als je meedoet aan geneesmiddelenonderzoek, moet je een paar keer per dag iets doen voor het onderzoek, zoals een test of gezondheidscheck. Maar je hebt ook veel tijd voor jezelf! In het onderzoekscentrum vind je van alles om die tijd mee in te vullen. Er zijn bijvoorbeeld computers, Playstations, tv’s met Netflix, maar ook een tafeltennistafel, pooltafel en een dartbord. En natuurlijk is er wifi, dus neem gerust je eigen laptop of tablet mee. Sommige deelnemers gaan voor hun werk of studie aan de slag. Maar je kunt natuurlijk ook een paar dagen lekker ontspannen.

Hoeveel geld je krijgt voor jouw deelname aan een geneesmiddelenonderzoek, wordt bepaald door de duur van het onderzoek. Hoe langer het onderzoek duurt, hoe hoger de vergoeding. Maar er zijn meer factoren die de hoogte van de vergoeding bepalen, zoals speciale medische handelingen.

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