A Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects.

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Metabolism and Nutrition Disorder

Obesity

Treatments

Drug: liraglutide

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02717858

NN8022-4192

U1111-1163-4641 (Other Identifier)

2014-004772-38 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the effects of liraglutide on gallbladder emptying in overweight and obese subjects.

Enrollment

52 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
Body mass index (BMI) equal to or above 27.0 kg/m^2
Stable body weight (less than 3 kg self-reported change during the previous 3 months)
Ultrasound assessment of gallbladder volume of an acceptable quality at screening, as judged by the investigator

Exclusion criteria

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or longacting injections))
History of gastrointestinal surgery or other medical procedure precluding gallbladder emptying assessment (appendectomy is allowed) or any significant digestive disease per the judgement of the investigator
History of pancreatitis (acute or chronic) or any gallbladder disease (incl. gallstones, gallbladder sludge, or polyps)
Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol