Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE - Maintenance
NCT ID: NCT00781937
Last Updated: 2017-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
422 participants
INTERVENTIONAL
2008-10-30
2010-09-01
Brief Summary
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Trial has following trial periods: A 12-week run-in period (from week -12 to week 0) followed by a 56-week main trial period (weeks 0-56) and a 12-week follow-up period (weeks 56-68).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lira 3.0 mg
A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
liraglutide
Liraglutide 3.0 mg per day administered in a 6.0 mg/mL, 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily
Placebo
A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
placebo
Liraglutide placebo 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily
Interventions
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liraglutide
Liraglutide 3.0 mg per day administered in a 6.0 mg/mL, 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily
placebo
Liraglutide placebo 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily
Eligibility Criteria
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Inclusion Criteria
* Stable body weight during the previous 3 months (less than 5 kg self-reported weight change)
* Previously undergone dietary weight loss and was not able to maintain reduced weight
Exclusion Criteria
* Previous treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (including liraglutide or exenatide), within the last 3 months
* Visit 1 thryoid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome)
* Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial
* Current participation in an organized diet reduction program (or within the last 3 months)
* Currently using or have used within three months before this trial: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phenteremine, or metformin
* Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry)
* History of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders or diagnosis of an eating disorder
* Subjects with a lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Goodyear, Arizona, United States
Novo Nordisk Investigational Site
Peoria, Arizona, United States
Novo Nordisk Investigational Site
Huntington Beach, California, United States
Novo Nordisk Investigational Site
Montclair, California, United States
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States
Novo Nordisk Investigational Site
Hialeah, Florida, United States
Novo Nordisk Investigational Site
Pembroke Pines, Florida, United States
Novo Nordisk Investigational Site
Atlanta, Georgia, United States
Novo Nordisk Investigational Site
Meridian, Idaho, United States
Novo Nordisk Investigational Site
Louisville, Kentucky, United States
Novo Nordisk Investigational Site
Madisonville, Kentucky, United States
Novo Nordisk Investigational Site
Southfield, Michigan, United States
Novo Nordisk Investigational Site
St Louis, Missouri, United States
Novo Nordisk Investigational Site
Butte, Montana, United States
Novo Nordisk Investigational Site
Endwell, New York, United States
Novo Nordisk Investigational Site
New York, New York, United States
Novo Nordisk Investigational Site
Wilmington, North Carolina, United States
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, United States
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Charleston, South Carolina, United States
Novo Nordisk Investigational Site
Nashville, Tennessee, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Round Rock, Texas, United States
Novo Nordisk Investigational Site
Norfolk, Virginia, United States
Novo Nordisk Investigational Site
Winnipeg, Manitoba, Canada
Novo Nordisk Investigational Site
Burlington, Ontario, Canada
Novo Nordisk Investigational Site
Hamilton, Ontario, Canada
Novo Nordisk Investigational Site
Sarnia, Ontario, Canada
Novo Nordisk Investigational Site
Laval, Quebec, Canada
Novo Nordisk Investigational Site
Mirabel, Quebec, Canada
Novo Nordisk Investigational Site
Sherbrooke, Quebec, Canada
Novo Nordisk Investigational Site
Trois-Rivières, Quebec, Canada
Novo Nordisk Investigational Site
London, , Canada
Novo Nordisk Investigational Site
Montreal, , Canada
Countries
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References
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O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. doi: 10.4158/EP151181.OR. Epub 2016 Aug 2.
Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6.
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.
McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814.
Steinberg WM, Rosenstock J, Wadden TA, Donsmark M, Jensen CB, DeVries JH. Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Pooled Data From the SCALE Clinical Development Program. Diabetes Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4.
O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21.
Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN8022-1923
Identifier Type: -
Identifier Source: org_study_id