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

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ClinicalTrials.gov Identifier: NCT02717858
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorder Obesity Drug: liraglutide Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 16, 2016
Actual Primary Completion Date : February 27, 2017
Actual Study Completion Date : February 27, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide Drug: 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.

Placebo Comparator: Placebo Drug: placebo
Injected s.c./subcutaneously (under the skin) once daily.




Primary Outcome Measures :
  1. Maximum postprandial gallbladder ejection fraction (GBEFmax) [ Time Frame: At 12 weeks (visit 9) ]

Secondary Outcome Measures :
  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) ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717858


Locations
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Denmark
Novo Nordisk Investigational Site
Hellerup, Denmark, 2900
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02717858    
Other Study ID Numbers: NN8022-4192
2014-004772-38 ( EudraCT Number )
U1111-1163-4641 ( Other Identifier: WHO )
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Nutrition Disorders
Overweight
Body Weight
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists