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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-16

Study Completion Date

2017-02-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Metabolism and Nutrition Disorder Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Liraglutide

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Injected s.c./subcutaneously (under the skin) Dose escalation period starting with liraglutide 0.6 mg per day and escalated with weekly increments of 0.6 mg until the target dose 3.0 mg is reached.

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Injected s.c./subcutaneously (under the skin) once daily.

Interventions

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liraglutide

Injected s.c./subcutaneously (under the skin) Dose escalation period starting with liraglutide 0.6 mg per day and escalated with weekly increments of 0.6 mg until the target dose 3.0 mg is reached.

Intervention Type DRUG

placebo

Injected s.c./subcutaneously (under the skin) once daily.

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No