The effect of liraglutide on MMC activity, gastrointestinal hormones, hunger ratings and ad libitum food intake in healthy volunteers.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

7 Feb 2020 → ongoing

Decision date (initial)

2024-12-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518641-21-00

EudraCT number

2018-001949-13

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To detect changes in migrating motor complex (MMC) activity after administration of liraglutide compared to placebo.

Conditions and MedDRA coding

Obesity

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Subject is female or male between 18 and 65 years of age.
2. 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.
3. 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.
4. Subject understands the study procedures and agrees to participate in the study by giving written informed consent.

Exclusion criteria 15

1. Subject is under age of legal consent, pregnant or breastfeeding.
2. Subject with a BMI ≤ 18 kg/m² or BMI ≥ 25 kg/m².
3. Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies.
4. Subject has diabetes.
5. Subject has a significant heart, lung, liver or kidney disease.
6. Subject has any history of a neurological disorder.
7. Subject has a history of abdominal surgery. Those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate.
8. Subject shows abnormal eating behavior or has an eating disorder.
9. History or current use of drugs that can affect glycaemia, gastrointestinal function, motility or sensitivity or gastric acidity.
10. History or current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit).
11. Subject consumes excessive amounts of alcohol, defined as >14 units per week for women and >21 units per week for men.
12. 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.
13. High caffeine intake (> 500 ml coffee daily or equivalent).
14. Inability or unwillingness to perform all of the study procedures, or the subject is considered unsuitable in any way by the principal investigator.
15. Recent participation (<30 days) or simultaneous participation in another clinical study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To detect changes in MMC activity after the administration of liraglutide compared to placebo.

Secondary endpoints 4

1. A difference in gastrointestinal hormone release compared between placebo and liraglutide treatment
2. A difference in hunger sensations compared between placebo and liraglutide treatment
3. A difference in ad libitum food intake compared between placebo and liraglutide treatment
4. A difference in whole blood glucose levels compared between placebo and liraglutide treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Jan Tack

Public contact point

Organisation

UZ Leuven

Contact name

Jan Tack

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications