LIRHV

UnknownPhase 4

The Effect of Liraglutide on the GIT

The Effect of Liraglutide on MMC Activity, Gastrointestinal Hormones, Hunger Ratings and ad Libitum Food Intake in Healthy Volunteers

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Healthy volunteers

Key I/E criterion

•BMI 18-25

Primary endpoint

•MMC activity compared between placebo and treatment with liraglutide

Identifiers

Registered as

NCT IDNCT04008290

Org study IDS61865

Timeline

Milestones

Study first posted2019-07-05actual

Last update posted2019-07-05actual

Study start2020-04-01estimated

Primary completion2021-04-01estimated

Study completion2021-04-01estimated

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

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 nonchildbearing 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.

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.

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Glycemic / diabetes

Patient-reported / QoL

Other clinical outcomes

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Glucose whole blood levels compared between placebo and treatment with liraglutide

Time frame:Reference sample is taken at 7:50 in the morning. Other glucose samples are taken from every 30 min after the injection (8am). The 4th day, this stops at 13:00 and the 5th day at 15:00. No samples are taken during the buffet at day 5 (13:30 until 14:15).

descriptive

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Hunger sensations compared between placebo and treatment with liraglutide

Time frame:Hunger is scored every 5 min for 6 hours at day 4 of the treatment, starting at 7:00 and ending at 13:00. At day 5, hunger is scored every 5 min for 7 hours and 20 min starting at 7:40 and ending at 15:00, except during 13:30 and 14:15 (buffet).

descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Ad libitum food intake compared between placebo and treatment with liraglutide

Time frame:The buffet will be given 5 hours after the consumption of a standardized breakfast which was given half an hour after the subcutaneous injection. Subjects have 45 min to finish the buffet.

descriptive, improvement

Other (unclassified)

2 endpoints

Primary/protocol endpoint

MMC activity compared between placebo and treatment with liraglutide

Time frame:The catheter will be placed 1 hour before the subcutaneous administration. Antroduodenal contractility will be measured for 5 hours after liraglutide or placebo injection.

descriptive

Secondary/protocol endpoint/low confidence

Gastrointestinal hormone release compared between placebo and treatment with liraglutide

Time frame:Reference sample is taken at 7:50 in the morning. Other blood samples are taken from every 30 min after the injection (8am). The 4th day, this stops at 13:00 and the 5th day at 15:00. No samples are taken during the buffet at day 5 (13:30 until 14:15).

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.