The effect of a gastrointestinal hormone (GLP-1)agonist on gastrointestinal contractility during the fasted state, gastrointestinal hormones, hunger ratings and ad libitum food intake in healthy volunteers

Phase 1

• Conditions: 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]

• Registration Number: EUCTR2018-001949-13-BE
• Lead Sponsor: KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-03
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 15

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To detect changes in MMC activity after administration of liraglutide compared to placebo. ;<br> Secondary Objective: 1)To detect changes in the release of gastrointestinal hormones after liraglutide compared to placebo.<br> 2)To detect changes in hunger after liraglutide compared to placebo.<br> 3)To detect changes in ad libitum food intake after liraglutide compared to placebo.<br> 4)To detect changes in blood glucose levels after liraglutide compared to placebo.<br> ;Primary end point(s): MMC activity compared between placebo and treatment with liraglutide.;<br> Timepoint(s) of evaluation of this end point: The volunteers have 10 visits in total for this study, for each condition 5 consecutive days.<br> At day 4 and 9 (the cross-over of conditions), the MMC is continuously measured, starting at 7 am until 1 pm.<br>