The study will focus on the underlying mechanisms of obesity. The effects will first be investigated in healthy, lean volunteers. MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Victoza
Product Name: Liraglutide
Pharmaceutical Form: Solution for injection in pre-filled pen
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration
Sponsors
KU Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject is female or male between 18 and 65 years of age. Subject has a BMI between 18 and 25 kg/m² and has a stable body weight for at least 3 consecutive months at the start of the study and keeps a stable weight during the study visits. Women of child-bearing potential agree to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses. Subject understands the study procedures and agrees to participate in the study by giving written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject is under age of legal consent, pregnant or breastfeeding. Subject with a BMI = 18 kg/m² or BMI = 25 kg/m². Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies. Subject has diabetes. Subject has a significant heart, lung, liver or kidney disease. Subject has any history of a neurological disorder. Subject has a history of abdominal surgery. Those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate. Subject shows abnormal eating behavior or has an eating disorder. History or current use of drugs that can affect glycaemia, gastrointestinal function, motility or sensitivity or gastric acidity. History or current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit). Subject consumes excessive amounts of alcohol, defined as >14 units per week for women and >21 units per week for men. Subject is currently (defined as within approximately 1 year of the screening visit) a regular or irregular user (including “recreational use”) of any illicit drugs (including marijuana) or has a history of drug (including alcohol) abuse. Further, patient is unwilling to refrain from the use of drugs during this study. High caffeine intake (> 500 ml coffee daily or equivalent). Inability or unwillingness to perform all of the study procedures, or the subject is considered unsuitable in any way by the principal investigator. Recent participation (<30 days) or simultaneous participation in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To detect changes in MMC activity after administration of liraglutide compared to placebo. ;Secondary Objective: 1)To detect changes in the release of gastrointestinal hormones after liraglutide compared to placebo. 2)To detect changes in hunger after liraglutide compared to placebo. 3)To detect changes in ad libitum food intake after liraglutide compared to placebo. 4)To detect changes in blood glucose levels after liraglutide compared to placebo. ;Primary end point(s): MMC activity compared between placebo and treatment with liraglutide.;Timepoint(s) of evaluation of this end point: The volunteers have 10 visits in total for this study, for each condition 5 consecutive days. At day 4 and 9 (the cross-over of conditions), the MMC is continuously measured, starting at 7 am until 1 pm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Gastrointestinal hormone release compared between placebo and treatment with liraglutide - Hunger sensations compared between placebo and treatment with liraglutide - Ad libitum food intake compared between placebo and treatment with liraglutide - Glucose whole blood levels compared between placebo and treatment with liraglutide ;Timepoint(s) of evaluation of this end point: The volunteers have 10 visits in total for this study, for each treatment arm 5 consecutive days. Blood samples will be measured at days: 4, 5, 9 and 10. A first blood sample is taken prior to the treatment (placebo or liraglutide). For day 4 and 9 after the injection, blood samples are collected every 30 min until 1 pm. For day 5 and 10 after the injection, blood samples are collected every 30 min until 1.30 pm and one more sample at 3 pm after the ad libitum buffet. Hunger, prospective food consumption and satiety will be scored every 5 min and hunger related symptoms will be scored on VAS of 100 mm every 30 min from the start of the study until the end of the study on days 4, 5, 9 and 10. On day 5 and 10, the volunteers eat ad libitum from a free choice buffet. | — |
Countries
Belgium
Contacts
Public ContactClinical Trials into TARGID
KU Leuven
Outcome results
None listed