Phase 3 N=422 Randomized Double-blind Treatment

Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE - Maintenance

Metabolism and Nutrition Disorder · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT00781937 ↗

Enrolled (actual)

422

Serious AEs

3.3%

Results posted

Nov 2011

Primary outcome: Primary: Mean Percentage Change in Fasting Body Weight From Baseline — -6.11; -0.05 percentage — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: liraglutide (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novo Nordisk A/S
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Percentage Change in Fasting Body Weight From Baseline	-6.11; -0.05	<0.0001 sig
PRIMARY Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0	80.8; 47.9	<0.0001 sig
PRIMARY Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0	50.5; 21.9	<0.0001 sig
SECONDARY Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0	26.1; 6.3	<0.0001 sig
SECONDARY Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0	1.9; 17.5	<0.0001 sig
SECONDARY Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0	0; 2.9	—
SECONDARY Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0	93.2; 70.9	<0.0001 sig
SECONDARY Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0	87.4; 54.4	<0.0001 sig
SECONDARY Change From Baseline in Fasting Weight	-5.7; 0.16	<0.0001 sig
SECONDARY Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period	-3.83; 0.41	<0.0001 sig
SECONDARY Change From Baseline in Blood Pressure	1.31; 4.03; 1.81; 2.15	0.0068 sig
SECONDARY Change From Baseline in Pulse	4.12; 3.15	0.1968
SECONDARY Change From Baseline in Fasting Lipid Profile: Triglycerides	0.02; 0.12	0.0310 sig
SECONDARY Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol	0.24; 0.33	0.1098
SECONDARY Change From Baseline in Fasting Lipid Profile: Total Cholesterol	0.22; 0.33	0.1149
SECONDARY Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)	-11.31; 1.70	0.0141 sig
SECONDARY Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56	31.4; 36.7	0.1199
SECONDARY Change From Baseline in Waist Circumference	-4.36; -0.86	<0.0001 sig
SECONDARY Change From Baseline in Body Mass Index (BMI)	-1.90; 0.15	<0.0001 sig
SECONDARY Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)	8.51; 6.16	0.3689
SECONDARY Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)	-0.01; 0.08	0.0053 sig
SECONDARY Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)	-0.52; -0.14	<0.0001 sig
SECONDARY Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin	0.50; 2.35	0.0147 sig
SECONDARY Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)	-0.14; 0.13	<0.0001 sig
SECONDARY Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)	65; 66; 63; 63; 18; 25	—
SECONDARY Binge Eating Scale Scores by Week and Severity	7.8; 7.8; 6.6; 8.6; 6.6; 6.9	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00781937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.