Conditions: Metabolism and Nutrition Disorder Obesity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3731
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: liraglutide intervention 2: placebo intervention 3: liraglutide intervention 4: placebo
Intervention descriptions: intervention 1: 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). intervention 2: 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). intervention 3: Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks. intervention 4: Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.

Protocol document: