Clinical trial NCT00781937: Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE - Maintenance
Official title: Effect of Liraglutide on Long-term Weight Maintenance and Additional Weight Loss Induced by a 4 to 12 Week Low Calorie Diet in Obese Subjects; A 56 Week Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial With a 12 Week Follow-up Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-10-29
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in North America. The aim of this clinical trial is to evaluate the potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as well as in overweight subjects who have medical problems such as hypertension (high blood pressure) or dyslipidaemia (an abnormal amount of lipids in the blood).

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).


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) of either 30 kg/m\^2 or more or BMI of less than 30 kg/m\^2 to 27 kg/m\^2 with presence of co-morbidities
* 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:

* Diagnosis of type 1 or type 2 diabetes
* 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

Primary outcomes:
measure: Mean Percentage Change in Fasting Body Weight From Baseline
timeFrame: Week 0, week 56
measure: Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0
timeFrame: Week 0, week 56
measure: Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0
timeFrame: Week 0, week 56
Secondary outcomes:
measure: Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0
timeFrame: Week 0, week 56
measure: Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0
timeFrame: Week 0, week 56
measure: Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0
timeFrame: Week 0, week 56
measure: Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0
timeFrame: Week 0, week 56
measure: Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0
timeFrame: Week 0, week 56
measure: Change From Baseline in Fasting Weight
timeFrame: Week 0, week 56
measure: Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period
timeFrame: Week 0, week 68
measure: Change From Baseline in Blood Pressure
timeFrame: Week 0, week 56
measure: Change From Baseline in Pulse
timeFrame: Week 0, week 56
measure: Change From Baseline in Fasting Lipid Profile: Triglycerides
timeFrame: Week 0, week 56
measure: Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol
timeFrame: Week 0, week 56
measure: Change From Baseline in Fasting Lipid Profile: Total Cholesterol
timeFrame: Week 0, week 56
measure: Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)
timeFrame: Week 0, week 56
measure: Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56
timeFrame: Week 56
measure: Change From Baseline in Waist Circumference
timeFrame: Week 0, week 56
measure: Change From Baseline in Body Mass Index (BMI)
timeFrame: Week 0, week 56
measure: Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)
timeFrame: Week 0, week 56
measure: Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)
timeFrame: Week 0, week 56
measure: Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)
timeFrame: Week 0, week 56
measure: Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin
timeFrame: Week 0, week 56
measure: Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)
timeFrame: Week 0, week 56
measure: Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)
timeFrame: Week 0 and week 56
measure: Binge Eating Scale Scores by Week and Severity
timeFrame: Week 0, week 50 and week 57
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Peoria
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Huntington Beach
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Montclair
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Hialeah
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Meridian
country: United States
facility: Novo Nordisk Investigational Site
state: Idaho
city: Louisville
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Madisonville
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Southfield
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Saint Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Butte
country: United States
facility: Novo Nordisk Investigational Site
state: Montana
city: Endwell
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Wilmington
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Winnipeg
country: Canada
facility: Novo Nordisk Investigational Site
state: Manitoba
city: Burlington
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Laval
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Mirabel
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Trois Rivières
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: London
country: Canada
facility: Novo Nordisk Investigational Site
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814.
citation: 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.
citation: 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.
citation: 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.