This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America. The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline. Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3,731
Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide 3.0 mg for 12 weeks (until week 68).
Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide placebo for 12 weeks (until week 68).
Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.
Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.
Novo Nordisk Investigational Site
Birmingham, Alabama, United States
Novo Nordisk Investigational Site
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Anaheim, California, United States
Novo Nordisk Investigational Site
Concord, California, United States
Novo Nordisk Investigational Site
Huntington Beach, California, United States
Change From Baseline in Fasting Body Weight
The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).
Time frame: Week 0, Week 56
Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.
Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
Time frame: At Week 56
Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight
Percentage of subjects losing \>10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
Time frame: At 56 weeks
Proportion of Subjects With Onset of Type 2 Diabetes
Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
Time frame: At 160 weeks
Change From Baseline in Waist Circumference (cm)
The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).
Time frame: Week 0, Week 56
Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)
The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
Time frame: Week 0, week 160
Pre-diabetes Status After 56 Weeks of Treatment
Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).
Time frame: Week 0, Week 56
Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment
Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
Time frame: Week 0, week 160
Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)
The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
Time frame: Week 0, week 160
Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)
Percentage of subjects losing \>=5% and percentage of subjects losing \>10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
Time frame: At 160 weeks
Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)
The observed mean change in fasting body weight (%) from week 56 to week 68 in re-randomised subjects (with no pre-diabetes at baseline) after 12-weeks of treatment (re-randomised treatment period).
Time frame: Week 56, Week 68
Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)
The observed mean change from baseline in fasting body weight (%) in re-randomised subjects (with no pre-diabetes at baseline) after 68 weeks of treatment (main + re-randomised treatment period).
Time frame: Week 0, Week 68
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Novo Nordisk Investigational Site
La Jolla, California, United States
Novo Nordisk Investigational Site
San Diego, California, United States
Novo Nordisk Investigational Site
San Diego, California, United States
Novo Nordisk Investigational Site
Santa Monica, California, United States
Novo Nordisk Investigational Site
Aurora, Colorado, United States
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