ObesityPhase 4LIRHVNCT04008290
The Effect of Liraglutide on the GIT
A Phase 4 study testing 0.6 mg Liraglutide in people with Obesity, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
Liraglutide is a glucose-like peptide 1 agonist, currently used as an effective weight-loss treatment. Its mechanism of action has not yet been elucidated. We want to investigate whether liraglutide affects MMC activity, gastrointestinal hormone release, glucose whole blood levels, hunger ratings and ad libitum food… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- 0.6 mg Liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Apr 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Liraglutide on MMC Activity, Gastrointestinal Hormones, Hunger Ratings and ad Libitum Food Intake in Healthy Volunteers
Liraglutide is a glucose-like peptide 1 agonist, currently used as an effective weight-loss treatment. Its mechanism of action has not yet been elucidated. We want to investigate whether liraglutide affects MMC activity, gastrointestinal hormone release, glucose whole blood levels, hunger ratings and ad libitum food intake in healthy volunteers.
Read the detailed description
Liraglutide is a glucose-like peptide 1 (GLP-1) agonist, currently used as an effective weight-loss treatment. Its mechanism of action has not yet been elucidated. GLP-1 infusion in humans suppresses hunger-inducing MMC contractility.
Therefore, we will recruit 15 healthy subjects which will participate to this double-blind, placebo-controlled crossover trial. The subjects will receive both treatment arms: 5 consecutive days of placebo injection or 0.6 mg liraglutide injection. On the 4th day, the injection will be combined with a motility study (fasted state), and on the 5th day with an ad libitum buffet.
The primary outcome of this study is to investigate whether liraglutide decreases MMC activity, measured by a solid-state, high-resolution manometry catheter (only on 4th day of the treatment arm). The amount and preference for certain types of food is tested during an ad libitum free choice buffet (only on 5th day of treatment arm). The effect on gastrointestinal hormone release will be measured by taking blood samples at regular time points (both 4th and 5th day of treatment arm). In parallel with the blood sample collection, glucose whole blood levels are measured. Hunger-related sensations are scored on a visual analog scale of 100 mm at regular time points (both 4th and 5th day of treatment arm).
- Conditions
- Obesity
- Being tested
- 0.6 mg Liraglutide, Placebo
- Keywords
- Liraglutide, MMC, Motilin, Ghrelin, Hunger, glucose, ad libitum food intake
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.6 mg LiraglutideDrug
Also called Victoza
For a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of 0.6 mg liraglutide. The injection will be placed by a trained nurse at 8 o'clock every morning. A wash out period of at least one week will be respected between the two treatment weeks.
PlaceboDrug
Also called saline solution
For a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of placebo (0.9% saline solution). The injection will be placed by a trained nurse at 8 o'clock every morning. A wash out period of at least one week will be respected between the two treatment weeks.
| Study group | Role | What they receive |
|---|---|---|
| 0.6 mg Liraglutide | Experimental | For a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of 100 µl containing 0.6 mg liraglutide. Receives: Drug: 0.6 mg Liraglutide |
| Placebo | Placebo comparator | For a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of 100 µl saline (0.9%) solution. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMC activity compared between placebo and treatment with liraglutide
On the 4th day of a treatment arm, the liraglutide or placebo injection is combined with a motility study. A solid-state, high-resolution manometry catheter is placed to measure intragastric pressure (IGP; mmHg). Antroduodenal contractility will be measured during the fasted state.
Measured: The catheter will be placed 1 hour before the subcutaneous administration. Antroduodenal contractility will be measured for 5 hours after liraglutide or placebo injection.
Secondary outcomes (4)
Gastrointestinal hormone release compared between placebo and treatment with liraglutide
On the 4th and 5th day of a treatment arm, blood samples are taken to measure motilin and ghrelin release in the plasma at regular time points.
Measured: 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).
Hunger sensations compared between placebo and treatment with liraglutide
On the 4th and 5th day of a treatment arm, hunger sensations (hunger, prospective hunger and satiety) are scored on a visual analog scale of 100 mm.
Measured: 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).
Ad libitum food intake compared between placebo and treatment with liraglutide
On the 5th day of a treatment arm, the liraglutide or placebo injection is combined with an ad libitum buffet test. In the morning, the subjects eat a standardized breakfast. Five hours later, the subjects have the opportunity to eat ad libitum from a free choice buffet. All types of food are presented, and all are weighted before and after the experiment to measure the consumed amount of calories.
Measured: 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.
Glucose whole blood levels compared between placebo and treatment with liraglutide
On the 4th and 5th day of a treatment arm, glucose whole blood levels are measured directly with a glucometer in parallel with the collection of blood samples.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008290
- Sponsor's protocol ID
- S61865
- Acronym
- LIRHV
- Status last verified
- Jul 2019
- First submitted
- 11 Jun 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Liraglutide on MMC Activity, Gastrointestinal Hormones, Hunger Ratings and ad Libitum Food Intake in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04008290
- Acronym / sponsor ID
- LIRHV / S61865
- Conditions
- Obesity
- Keywords
- Liraglutide, MMC, Motilin, Ghrelin, Hunger, glucose, ad libitum food intake
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Liraglutide is a glucose-like peptide 1 agonist, currently used as an effective weight-loss treatment. Its mechanism of action has not yet been elucidated. We want to investigate whether liraglutide affects MMC activity, gastrointestinal hormone release, glucose whole blood levels, hunger ratings and ad libitum food intake in healthy volunteers.
Detailed description
Liraglutide is a glucose-like peptide 1 (GLP-1) agonist, currently used as an effective weight-loss treatment. Its mechanism of action has not yet been elucidated. GLP-1 infusion in humans suppresses hunger-inducing MMC contractility.
Therefore, we will recruit 15 healthy subjects which will participate to this double-blind, placebo-controlled crossover trial. The subjects will receive both treatment arms: 5 consecutive days of placebo injection or 0.6 mg liraglutide injection. On the 4th day, the injection will be combined with a motility study (fasted state), and on the 5th day with an ad libitum buffet.
The primary outcome of this study is to investigate whether liraglutide decreases MMC activity, measured by a solid-state, high-resolution manometry catheter (only on 4th day of the treatment arm). The amount and preference for certain types of food is tested during an ad libitum free choice buffet (only on 5th day of treatment arm). The effect on gastrointestinal hormone release will be measured by taking blood samples at regular time points (both 4th and 5th day of treatment arm). In parallel with the blood sample collection, glucose whole blood levels are measured. Hunger-related sensations are scored on a visual analog scale of 100 mm at regular time points (both 4th and 5th day of treatment arm).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.6 mg Liraglutide | Experimental | Drug: 0.6 mg LiraglutideFor a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of 100 µl containing 0.6 mg liraglutide. |
| Placebo | Placebo comparator | Drug: PlaceboFor a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of 100 µl saline (0.9%) solution. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.6 mg LiraglutideAlso: VictozaFor a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of 0.6 mg liraglutide. The injection will be placed by a trained nurse at 8 o'clock every morning. A wash out period of at least one week will be respected between the two treatment weeks. | Drug | 0.6 mg Liraglutide |
| PlaceboAlso: saline solutionFor a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of placebo (0.9% saline solution). The injection will be placed by a trained nurse at 8 o'clock every morning. A wash out period of at least one week will be respected between the two treatment weeks. | Drug | Placebo |
Primary outcome
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.
On the 4th day of a treatment arm, the liraglutide or placebo injection is combined with a motility study. A solid-state, high-resolution manometry catheter is placed to measure intragastric pressure (IGP; mmHg). Antroduodenal contractility will be measured during the fasted state.
4 secondary outcomes
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).
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).
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.
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tack principal investigator
UZ Leuven
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.6 mg Liraglutide in people with Obesity, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wout Verbeure (16373765 ext. +32, wout.verbeure@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.