Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Overweight; Prediabetic State; Nutrition Disorders; Body Weight
Intervention: liraglutide; placebo; liraglutide; placebo
Intervention description: 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.
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3731.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained

          -  Body Mass Index (BMI) of 30.0 kg/m^2 or above

          -  Body Mass Index (BMI) of 27 kg/m^2 or above in the presence of co-morbidities of
             treated or untreated dyslipidemia and/or hypertension

          -  Stable body weight

          -  Preceding failed dietary effort

        Exclusion Criteria:

          -  Known type 1 or type 2 diabetes

          -  Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126
             mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma
             glucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2)

          -  Screening calcitonin of 50 ng/L or above

          -  Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial
             medullary thyroid carcinoma (FMTC)

          -  Personal history of non-familial medullary thyroid carcinoma

          -  History of acute or chronic pancreatitis

          -  Obesity induced by drug treatment

          -  Use of approved weight lowering pharmacotherapy

          -  Previous surgical treatment of obesity

          -  History of major depressive disorder or suicide attempt

          -  Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or
             diastolic blood pressure of 100 mmHg or above)