Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-31 @ 9:38 PM
Study NCT ID:
NCT02717858
Status:
COMPLETED
Last Update Posted:
2018-06-28
First Post:
2016-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2016-03-15', 'studyFirstSubmitQcDate': '2016-03-18', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum postprandial gallbladder ejection fraction (GBEFmax)', 'timeFrame': 'At 12 weeks (visit 9)'}], 'secondaryOutcomes': [{'measure': 'GBEFmax (maximum gallbladder ejection fraction) after first treatment dose', 'timeFrame': 'At first treatment dose (visit 4, day 2)'}, {'measure': 'Gallbladder volume', 'timeFrame': 'At first dose (visit 4, day2),after 12 weeks (visit 9, day 85)'}, {'measure': 'Gallbladder volume', 'timeFrame': 'At 12 weeks (visit 9)'}, {'measure': 'Area under gallbladder EF-time (ejection fraction) curve', 'timeFrame': 'At first dose (visit 4, day 2),after 12 weeks (visit 9, day 85)'}, {'measure': 'Area under gallbladder EF-time curve', 'timeFrame': 'At 12 weeks (visit 9)'}, {'measure': 'Area under the paracetamol concentration-time curve', 'timeFrame': 'At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)'}, {'measure': 'Area under the paracetamol concentration-time curve', 'timeFrame': 'At 12 weeks (visit 9)'}, {'measure': 'Incremental area under the plasma glucose concentration-time curve', 'timeFrame': 'At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)'}, {'measure': 'Incremental area under the plasma glucose concentration-time curve', 'timeFrame': 'At 12 weeks (visit 9)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metabolism and Nutrition Disorder', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '29892986', 'type': 'RESULT', 'citation': 'Nexoe-Larsen CC, Sorensen PH, Hausner H, Agersnap M, Baekdal M, Bronden A, Gustafsson LN, Sonne DP, Vedtofte L, Vilsboll T, Knop FK. Effects of liraglutide on gallbladder emptying: A randomized, placebo-controlled trial in adults with overweight or obesity. Diabetes Obes Metab. 2018 Nov;20(11):2557-2564. doi: 10.1111/dom.13420. Epub 2018 Jul 10.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent\n* Body mass index (BMI) equal to or above 27.0 kg/m\\^2\n* Stable body weight (less than 3 kg self-reported change during the previous 3 months)\n* Ultrasound assessment of gallbladder volume of an acceptable quality at screening, as judged by the investigator\n\nExclusion Criteria:\n\n* 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))\n* 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\n* History of pancreatitis (acute or chronic) or any gallbladder disease (incl. gallstones, gallbladder sludge, or polyps)\n* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol"}, 'identificationModule': {'nctId': 'NCT02717858', 'briefTitle': 'A Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NN8022-4192'}, 'secondaryIdInfos': [{'id': '2014-004772-38', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1163-4641', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liraglutide', 'interventionNames': ['Drug: liraglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Liraglutide']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Injected s.c./subcutaneously (under the skin) once daily.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}