Fettleibigkeit

Die Studie

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

• 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.
• 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.

• 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.

Zeitraum

Part A consists of 1 period during which you will stay at the research center in Groningen for 9 days (8 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.

Aufwandsentschädigung

You will receive a gross compensation of € 3899 for full participation in one of the groups in Part A.

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.

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