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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
422
Liraglutide 3.0 mg per day administered in a 6.0 mg/mL, 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily
Liraglutide placebo 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily
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
Mean Percentage Change in Fasting Body Weight From Baseline
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time frame: Week 0, week 56
Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0
Subjects who had a weight regain less than or equal to 0.5% of weight from Week 0 were regarded as maintenance of run-in fasting weight loss. Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time frame: Week 0, week 56
Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time frame: Week 0, week 56
Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time frame: Week 0, week 56
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time frame: Week 0, week 56
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time frame: Week 0, week 56
Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time frame: Week 0, week 56
Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time frame: Week 0, week 56
Change From Baseline in Fasting Weight
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time frame: Week 0, week 56
Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time frame: Week 0, week 68
Change From Baseline in Blood Pressure
Time frame: Week 0, week 56
Change From Baseline in Pulse
Time frame: Week 0, week 56
Change From Baseline in Fasting Lipid Profile: Triglycerides
Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Time frame: Week 0, week 56
Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol
Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Time frame: Week 0, week 56
Change From Baseline in Fasting Lipid Profile: Total Cholesterol
Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Time frame: Week 0, week 56
Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)
Time frame: Week 0, week 56
Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56
Metabolic syndrome status required at least 3 of 5 criteria met: Waist circumference (men ≥102cm, women ≥88cm); Triglycerides \>1.7mmol/L; High density lipoprotein cholesterol (men \<0.9mmol/L, women \<1.1mmol/L) or on drug therapy; Blood pressure ≥130mmHg systolic or ≥85mmHg diastolic or on drug therapy; Fasting glucose ≥5.5mmol/L or on drug therapy.
Time frame: Week 56
Change From Baseline in Waist Circumference
Time frame: Week 0, week 56
Change From Baseline in Body Mass Index (BMI)
Time frame: Week 0, week 56
Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)
Change in beta-cell function percent values from Week 0 (X%) to Week 56 (Y%) was calculated \[X% - Y%\]. Beta-cell function was derived from fasting plasma glucose readings in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged \<35 years have median beta-cell function indexed at 100%.
Time frame: Week 0, week 56
Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)
Change in insulin resistance values from Week 0 (X) to Week 56 (Y) was calculated \[X - Y\]. Insulin resistance was derived from fasting serum insulin levels in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged \<35 years have median insulin resistance indexed at 1.00.
Time frame: Week 0, week 56
Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)
Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Time frame: Week 0, week 56
Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin
Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Time frame: Week 0, week 56
Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)
Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated \[X% - Y%\].
Time frame: Week 0, week 56
Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)
Number of subjects using concomitant medications at Week 0 and Week 56, respectively
Time frame: Week 0 and week 56
Binge Eating Scale Scores by Week and Severity
Binge Eating Scale (BES) scores are based on responses to the Binge Eating Scale Questionnaire, a 16-item self-reporting diagnostic tool scaled 0-46 (Non-binging: 0-17; Moderate: 17-26; Severe: 27-46)
Time frame: Week 0, week 50 and week 57
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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
...and 27 more locations