LIRAGLUTIDE for Obesity

Inclusion criteria

• {"criterion_text":"- Subject is female or male between 18 and 65 years of age."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Subject understands the study procedures and agrees to participate in the study by giving written informed consent."}

Exclusion criteria

• {"criterion_text":"- Subject is under age of legal consent, pregnant or breastfeeding."}
• {"criterion_text":"- History or current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit)."}
• {"criterion_text":"- Subject consumes excessive amounts of alcohol, defined as >14 units per week for women and >21 units per week for men."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- High caffeine intake (> 500 ml coffee daily or equivalent)."}
• {"criterion_text":"- Inability or unwillingness to perform all of the study procedures, or the subject is considered unsuitable in any way by the principal investigator."}
• {"criterion_text":"- Recent participation (<30 days) or simultaneous participation in another clinical study."}
• {"criterion_text":"- Subject with a BMI ≤ 18 kg/m² or BMI ≥ 25 kg/m²."}
• {"criterion_text":"- Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies."}
• {"criterion_text":"- Subject has diabetes."}
• {"criterion_text":"- Subject has a significant heart, lung, liver or kidney disease."}
• {"criterion_text":"- Subject has any history of a neurological disorder."}
• {"criterion_text":"- Subject has a history of abdominal surgery. Those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate."}
• {"criterion_text":"- Subject shows abnormal eating behavior or has an eating disorder."}
• {"criterion_text":"- History or current use of drugs that can affect glycaemia, gastrointestinal function, motility or sensitivity or gastric acidity."}

Primary endpoints

• {"endpoint_text":"- To detect changes in MMC activity after the administration of liraglutide compared to placebo.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- A difference in gastrointestinal hormone release compared between placebo and liraglutide treatment","definition_or_measurement_approach":""}
• {"endpoint_text":"- A difference in hunger sensations compared between placebo and liraglutide treatment","definition_or_measurement_approach":""}
• {"endpoint_text":"- A difference in ad libitum food intake compared between placebo and liraglutide treatment","definition_or_measurement_approach":""}
• {"endpoint_text":"- A difference in whole blood glucose levels compared between placebo and liraglutide treatment","definition_or_measurement_approach":""}

Belgium

Earliest CTIS Part Ii Submission Date

04-12-2024

Latest Decision Or Authorization Date

18-12-2024

Processing Time Days

14

Number Of Sites

1

Number Of Participants

15

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium