Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting (SCALE™ IBT)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Metabolism and Nutrition Disorder; Obesity

Treatments: Drug: liraglutide; Drug: placebo; Behavioral: CMS Intensive Behavior Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02963935

U1111-1177-5059 (Other Identifier)

NN8022-4274

Details and patient eligibility

About

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).

Enrollment: 282 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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282 participants in 2 patient groups, including a placebo group

Liraglutide

Experimental group

Treatment:

Behavioral: CMS Intensive Behavior Therapy

Drug: liraglutide

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

Behavioral: CMS Intensive Behavior Therapy