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

Completed · Phase 3 · Has a placebo group

Conditions studied: Metabolism and Nutrition Disorder, Obesity

In brief

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).

Key facts

Study ID

NCT01272219

Run by

Novo Nordisk A/S

People needed

3731

Starts

2011-06-01

Expected to finish

2015-03-02

Last updated by the study team

2018-01-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Novo Nordisk Investigational Site — Phoenix, Arizona, United States
• Novo Nordisk Investigational Site — Anaheim, California, United States
• Novo Nordisk Investigational Site — Concord, California, United States
• Novo Nordisk Investigational Site — Huntington Beach, California, United States
• Novo Nordisk Investigational Site — La Jolla, California, United States
• Novo Nordisk Investigational Site — San Diego, California, United States
• Novo Nordisk Investigational Site — San Diego, California, United States
• Novo Nordisk Investigational Site — Santa Monica, California, United States
• Novo Nordisk Investigational Site — Aurora, Colorado, United States
• Novo Nordisk Investigational Site — Colorado Springs, Colorado, United States
• Novo Nordisk Investigational Site — Golden, Colorado, United States
• Novo Nordisk Investigational Site — New London, Connecticut, United States
• Novo Nordisk Investigational Site — Waterbury, Connecticut, United States
• Novo Nordisk Investigational Site — Washington D.C., District of Columbia, United States
• Novo Nordisk Investigational Site — Boynton Beach, Florida, United States
• Novo Nordisk Investigational Site — Bradenton, Florida, United States
• Novo Nordisk Investigational Site — Crystal River, Florida, United States
• Novo Nordisk Investigational Site — Daytona Beach, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Ocala, Florida, United States
• Novo Nordisk Investigational Site — Ponte Vedra, Florida, United States
• Novo Nordisk Investigational Site — South Miami, Florida, United States
• Novo Nordisk Investigational Site — Athens, Georgia, United States
• Novo Nordisk Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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