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Completed

NCT Number: NCT02717858

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

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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Key information

Conditions

Metabolism and Nutrition Disorder Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

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

Drug

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

Primary outcomes

  1. Maximum postprandial gallbladder ejection fraction (GBEFmax)

    Time frame: At 12 weeks (visit 9)

Secondary outcomes

  1. GBEFmax (maximum gallbladder ejection fraction) after first treatment dose

    Time frame: At first treatment dose (visit 4, day 2)

  2. Gallbladder volume

    Time frame: At first dose (visit 4, day2),after 12 weeks (visit 9, day 85)

  3. Gallbladder volume

    Time frame: At 12 weeks (visit 9)

  4. Area under gallbladder EF-time (ejection fraction) curve

    Time frame: At first dose (visit 4, day 2),after 12 weeks (visit 9, day 85)

  5. Area under gallbladder EF-time curve

    Time frame: At 12 weeks (visit 9)

  6. Area under the paracetamol concentration-time curve

    Time frame: At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)

  7. Area under the paracetamol concentration-time curve

    Time frame: At 12 weeks (visit 9)

  8. Incremental area under the plasma glucose concentration-time curve

    Time frame: At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)

  9. Incremental area under the plasma glucose concentration-time curve

    Time frame: At 12 weeks (visit 9)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 24, 2016
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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