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Study on the Effects of Liraglutide on Hunger and Digestion in Obese Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called liraglutide on certain bodily functions in healthy individuals. The study is particularly interested in how liraglutide affects the activity of the migrating motor complex (MMC), which is a pattern of electromechanical activity in the gastrointestinal tract. The trial also examines changes in gastrointestinal hormones, feelings of hunger, and food intake. Liraglutide is administered as a solution for injection using a pre-filled pen. Participants in the study will receive either liraglutide or a placebo.

The main purpose of the study is to observe any changes in MMC activity after administering liraglutide compared to a placebo. Additionally, the study will look at differences in the release of gastrointestinal hormones, hunger sensations, and food intake between those receiving liraglutide and those receiving a placebo. The study will also measure changes in blood glucose levels. Participants will be involved in the study for a period of up to five days, during which they will receive the treatment through subcutaneous injection, meaning the injection is given under the skin.

This trial is particularly relevant for understanding how liraglutide might influence factors related to obesity, even though the participants themselves are healthy volunteers. The study aims to provide insights into how this medication could potentially be used to manage or treat conditions related to weight and appetite control. The trial is expected to conclude by the end of 2025.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide written informed consent, indicating your understanding and agreement to participate in the study procedures.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, body mass index (BMI), and ensuring your body weight has been stable for at least three months.
For women of child-bearing potential, confirmation of a highly effective method of birth control is required throughout the trial.
Step 3
Administration of medication
You will receive a subcutaneous injection, which is an injection under the skin, of either liraglutide or a placebo (saline solution).
The medication, Victoza 6 mg/ml solution for injection in pre-filled pen, will be administered as per the study protocol.
Step 4
Monitoring and assessments
Throughout the trial, you will undergo regular monitoring to assess changes in the activity of the migrating motor complex (MMC), which is a pattern of electromechanical activity in the gastrointestinal tract.
Additional assessments will include measuring gastrointestinal hormone levels, hunger sensations, food intake, and blood glucose levels.
Step 5
Completion of the study
Upon completion of the study, a final assessment will be conducted to gather all necessary data.
You will be informed about the next steps and any follow-up procedures, if applicable.

Who can join the trial?

6 criteria

The participant must be a female or male between 18 and 65 years old.
The participant must have a Body Mass Index (BMI) between 18 and 25 kg/m². BMI is a measure of body fat based on height and weight.
The participant must have a stable body weight for at least 3 consecutive months before the study starts and maintain a stable weight during the study visits.
Women of child-bearing potential must agree to use a highly effective method of birth control during the entire trial. This includes methods like implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or having a partner who has had a vasectomy.
Women of non-childbearing potential can participate if they are surgically sterile (such as having had a tubal ligation or hysterectomy) or are postmenopausal with at least 2 years without spontaneous menstrual periods.
The participant must understand the study procedures and agree to participate by giving written informed consent. This means they agree to join the study after being fully informed about what it involves.

Who cannot join the trial?

10 criteria

Patients with a history of severe allergic reactions to the study medication cannot participate.
Individuals with uncontrolled high blood pressure are excluded.
Patients with a history of heart disease or stroke are not eligible.
Those with severe liver or kidney disease cannot join the study.
Pregnant or breastfeeding women are not allowed to participate.
Individuals currently participating in another clinical trial are excluded.
Patients with a history of drug or alcohol abuse in the past year are not eligible.
Anyone with a mental health condition that affects their ability to consent or follow study procedures is excluded.
Individuals with a history of cancer in the past five years, except for certain skin cancers, cannot participate.
Patients with certain gastrointestinal disorders that affect digestion are not eligible.

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Katholieke Universiteit te Leuven
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Leuven, Belgium

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Investigated drugs

Liraglutide is a medication used in this clinical trial to study its effects on the digestive system. It is known to help control blood sugar levels in people with type 2 diabetes and is also used for weight management. In this trial, researchers are interested in how liraglutide affects the movement of the stomach and intestines, as well as its impact on hormones related to digestion and feelings of hunger. Participants will receive liraglutide to see if it changes the way their digestive system works compared to when they do not take the medication.

What is already known about the treatment

Liraglutide – Liraglutide is administered as an injection under the skin, typically in the abdomen, thigh, or upper arm. It is currently being studied for its effects on gastrointestinal activity and hunger in healthy individuals, with a focus on its potential benefits for obesity management. The medication works by mimicking a hormone in the body that helps regulate appetite and digestion, leading to reduced food intake and weight loss. Liraglutide belongs to a class of drugs known as GLP-1 receptor agonists, which are used to help control blood sugar levels and support weight management.

Investigated diseases

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It develops when there is an imbalance between calories consumed and calories expended, leading to energy storage in the form of fat. Over time, this excess fat can accumulate in various parts of the body, including under the skin and around internal organs. The progression of obesity can lead to increased body mass index (BMI) and changes in body shape and size. As obesity progresses, it can affect metabolic processes and may lead to changes in hormone levels and appetite regulation. This condition can also influence the body's ability to regulate blood sugar and may impact overall energy levels.