Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
235 participants
INTERVENTIONAL
2017-01-31
2020-10-13
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Liraglutide 3.0 mg
Drug: Liraglutide Active Drug
Other Names:
* Saxenda
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.
Liraglutide
Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Placebo
Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL
Other Names:
* Placebo
* Saline injection
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.
Placebo
Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Interventions
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Liraglutide
Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Placebo
Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
* BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with metabolic syndrome
* Metabolic syndrome is defined as at least three of the following:3
1. waist circumference \> 102 cm (40 in) in men and 88 cm (35 in) in women
2. triglycerides \> 150 mg/dL or on treatment for hypertriglyceridemia
3. HDL cholesterol \< 40 mg/dL in men and \< 50 mg/dL in women
4. blood pressure \> 130/85 mmHg or on treatment for hypertension
5. fasting glucose \> 100 mg/dL
Exclusion Criteria
* Receipt of any anti-obesity drug or supplement within 1 month prior to screening for this trial.
* Self-reported or clinically documented history of significant fluctuations (\>5% change) in weight within 3 months prior to screening for this trial.
* History of diabetes mellitus (type 1 or 2) or on treatment with anti-diabetes medication.
* History of chronic pancreatitis or idiopathic acute pancreatitis (current or prior history).
* History of gallbladder disease (cholelithiasis or cholecystitis).
* Chronic kidney disease stage III or greater (eGFR\<60 mL/min).
* Obesity induced by other endocrinologic disorders (e.g. Cushing Syndrome).
* Current or history of treatment with medications that may cause significant weight gain, within 1 month prior to screening for this trial, including systemic corticosteroids (except for a short course of treatment, i.e., 7- 10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g., imipramine, amitryptiline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium).
* Diet attempts using herbal supplements or over-the-counter medications within 1 month prior to screening for this trial.
* Current participation in an organized weight reduction program or within the last 1 month prior to screening for this trial.
* Participation in a clinical trial within the last 3 months prior to screening for this trial.
* Familial or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma.
* Personal history of non-familial medullary thyroid carcinoma.
* History of Major Depressive Disorder within the last 2 years.
* History of other severe psychiatric disorders, e.g., schizophrenia, bipolar disorder.
* Any lifetime history of a suicide attempt.
* A history of any suicidal behavior in the last month prior to randomization.
* Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator.
* Known or suspected hypersensitivity to trial product(s) or related product(s).
* Known or suspected abuse of alcohol or narcotics.
* Language barrier, mental incapacity, unwillingness or inability to understand.
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. These include abstinence and the following methods: diaphragm with spermicide, condom with spermicide (by male partner), intrauterine device, sponge, spermicide, Norplant®, Depo-Provera® or oral contraceptives.
35 Years
ALL
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Parag Joshi
M.D.
Principal Investigators
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Parag Joshi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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References
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Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Fernando Costa. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute scientific statement: Executive Summary. Crit Pathw Cardiol. 2005 Dec;4(4):198-203. doi: 10.1097/00132577-200512000-00018. No abstract available.
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McLaughlin T, Sherman A, Tsao P, Gonzalez O, Yee G, Lamendola C, Reaven GM, Cushman SW. Enhanced proportion of small adipose cells in insulin-resistant vs insulin-sensitive obese individuals implicates impaired adipogenesis. Diabetologia. 2007 Aug;50(8):1707-15. doi: 10.1007/s00125-007-0708-y. Epub 2007 Jun 5.
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Neeland IJ, Ayers CR, Rohatgi AK, Turer AT, Berry JD, Das SR, Vega GL, Khera A, McGuire DK, Grundy SM, de Lemos JA. Associations of visceral and abdominal subcutaneous adipose tissue with markers of cardiac and metabolic risk in obese adults. Obesity (Silver Spring). 2013 Sep;21(9):E439-47. doi: 10.1002/oby.20135. Epub 2013 May 19.
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Neeland IJ, Gupta S, Ayers CR, Turer AT, Rame JE, Das SR, Berry JD, Khera A, McGuire DK, Vega GL, Grundy SM, de Lemos JA, Drazner MH. Relation of regional fat distribution to left ventricular structure and function. Circ Cardiovasc Imaging. 2013 Sep;6(5):800-7. doi: 10.1161/CIRCIMAGING.113.000532. Epub 2013 Aug 8.
Britton KA, Massaro JM, Murabito JM, Kreger BE, Hoffmann U, Fox CS. Body fat distribution, incident cardiovascular disease, cancer, and all-cause mortality. J Am Coll Cardiol. 2013 Sep 3;62(10):921-5. doi: 10.1016/j.jacc.2013.06.027. Epub 2013 Jul 10.
Wadden TA, Hollander P, Klein S, Niswender K, Woo V, Hale PM, Aronne L; NN8022-1923 Investigators. Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study. Int J Obes (Lond). 2013 Nov;37(11):1443-51. doi: 10.1038/ijo.2013.120. Epub 2013 Jul 1.
Borga M, Thomas EL, Romu T, Rosander J, Fitzpatrick J, Dahlqvist Leinhard O, Bell JD. Validation of a fast method for quantification of intra-abdominal and subcutaneous adipose tissue for large-scale human studies. NMR Biomed. 2015 Dec;28(12):1747-53. doi: 10.1002/nbm.3432. Epub 2015 Nov 2.
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Neeland IJ, Marso SP, Ayers CR, Lewis B, Oslica R, Francis W, Rodder S, Pandey A, Joshi PH. Effects of liraglutide on visceral and ectopic fat in adults with overweight and obesity at high cardiovascular risk: a randomised, double-blind, placebo-controlled, clinical trial. Lancet Diabetes Endocrinol. 2021 Sep;9(9):595-605. doi: 10.1016/S2213-8587(21)00179-0. Epub 2021 Aug 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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STU 122015-044
Identifier Type: -
Identifier Source: org_study_id