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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004772-38 | EudraCT Number | ||
| U1111-1163-4641 | Other Identifier | WHO |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum postprandial gallbladder ejection fraction (GBEFmax) | At 12 weeks (visit 9) |
| Measure | Description | Time Frame |
|---|---|---|
| GBEFmax (maximum gallbladder ejection fraction) after first treatment dose | At first treatment dose (visit 4, day 2) | |
| Gallbladder volume | At first dose (visit 4, day2),after 12 weeks (visit 9, day 85) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Hellerup | 2900 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29892986 | Result | 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. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| placebo | Drug | Injected s.c./subcutaneously (under the skin) once daily. |
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| Gallbladder volume | At 12 weeks (visit 9) |
| Area under gallbladder EF-time (ejection fraction) curve | At first dose (visit 4, day 2),after 12 weeks (visit 9, day 85) |
| Area under gallbladder EF-time curve | At 12 weeks (visit 9) |
| Area under the paracetamol concentration-time curve | At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85) |
| Area under the paracetamol concentration-time curve | At 12 weeks (visit 9) |
| Incremental area under the plasma glucose concentration-time curve | At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85) |
| Incremental area under the plasma glucose concentration-time curve | At 12 weeks (visit 9) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |