Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Nutrition Disorders
Intervention: liraglutide; placebo; CMS Intensive Behavior Therapy
Intervention description: Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg; Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg; Intensive Behaviour Therapy for obesity
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 282.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in the United States of America (USA). The purpose of the trial is to
      investigate the effect and safety of liraglutide 3.0 mg as an adjunct to intensive behaviour
      therapy for obesity in a non-specialist setting (IBT-CMS: Intensive Behaviour Therapy for
      obesity in a primary care setting according to Centers for Medicare & Medicaid Services (CMS)
      visit schedule).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities. Trial-related
             activities are any procedures that are carried out as part of the trial, including
             activities to determine suitability for the trial

          -  BMI above or equal to 30 kg/m^2

          -  Male or female, age 18 years or older at the time of signing informed consent

        Exclusion Criteria:

          -  HbA1c (glycosylated haemoglobin) above or equal to 6.5% (at screening visit), or
             diagnosis of type 1 or type 2 diabetes mellitus

          -  Recent history of cardiovascular disease (myocardial infarction or stroke within the
             past 6 months), severe congestive heart failure (NYHA class III, IV), or second degree
             or greater heart block

          -  Personal or family history of Medullary Thyroid Carcinoma (MTC), or Multiple Endocrine
             Neoplasia type 2 (MEN2)

          -  Female who is pregnant, breast-feeding or intends to become pregnant or is of
             child-bearing potential and not using an adequate contraceptive method (adequate
             contraceptive measure as required by local regulation or practice)

          -  Use in past 90 days of medications known to induce significant weight loss (e.g.,
             prescription weight loss medications) or weight gain (e.g., chronic use of oral
             steroids, second generation antipsychotics)

          -  History of pancreatitis (acute or chronic)

          -  History of major depressive disorder within the past 2 years

          -  Any lifetime history of a suicide attempt

          -  Inadequately treated blood pressure defined as Grade 3 hypertension or higher
             (Systolic above or equal to 180 mmHg or diastolic above or equal to 110 mmHg)

          -  History of malignancy (except for non-melanoma skin cancer) within the past 5 years