The effect of liraglutide on MMC activity, gastrointestinal hormones, hunger ratings and ad libitum food intake in healthy volunteers - LIRHV

INTERVENTION: 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 of the placebo: Subcutaneous use CONDITION: 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 Therapeutic area: Body processes [G] ‐ Metabolic Phenomena [G03] PRIMARY OUTCOME: ; 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.; ; 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.; Main Objective: To detect changes in MMC activity after administration of liraglutide compared to placebo. Primary end point(s): MMC activity compared between placebo and treatment with liraglutide. SECONDARY OUTCOME: ; 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.; 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