Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Metabolism and Nutrition Disorder; Obesity

Treatments: Drug: placebo; Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01272219

2008-001049-24 (EudraCT Number)

NN8022-1839

U1111-1118-7871 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 3,731 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,731 participants in 5 patient groups, including a placebo group

Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)

Experimental group

Treatment:

Drug: placebo

Drug: placebo

Liraglutide Placebo, no Pre-diabetes

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Liraglutide 3.0mg, Pre-diabetes

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

Liraglutide Placebo, Pre-diabetes

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo