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



Status:Completed
Conditions:Obesity Weight Loss, Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/21/2018
Start Date:June 1, 2011
End Date:March 2, 2015

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Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Trial With Stratification of Subject to Either 56 or 160 Weeks of Treatment Based on Pre-diabetes Status at Randomisation

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).


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)
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Aurora, Colorado 80010
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Anaheim, California 92801
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Arlington, Virginia 22206
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Athens, Georgia 30606
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Aurora, Illinois 60506
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Austin, Texas 78731
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Baltimore, Maryland 21229
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Baton Rouge, Louisiana 70808
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Beaver, Pennsylvania 15009
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Birmingham, Alabama 35215
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Boynton Beach, Florida 33472
2701
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Bradenton, Florida 34201
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Bristol, Tennessee 37620
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Canal Fulton, Ohio 44614
2044
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Cary, North Carolina 27518
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Charleston, South Carolina 29407
2419
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Cincinnati, Ohio 45229
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Ciudad Autónoma de Bs As,
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Colorado Springs, Colorado 80910
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Concord, California 94520
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Crystal River, Florida 34429
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Dallas, Texas 75231
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Daytona Beach, Florida 32117
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Dunwoody, Georgia 30338
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Elkridge, Maryland 21075
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Eugene, Oregon 97401
250
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Franklin, Ohio 45005
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Golden, Colorado 80401
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Greer, South Carolina 29651
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Henrico, Virginia 23233
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Huntington Beach, California 92648
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Jacksonville, Florida 32207
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Kansas City, Missouri 64106
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La Jolla, California 92037
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Milwaukee, Wisconsin 53209
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New London, Connecticut 06320
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North Dartmouth, Massachusetts 02747
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Philadelphia, Pennsylvania 19104
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Ponte Vedra, Florida 32081
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Raleigh, North Carolina 27610
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Renton, Washington 98057
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Richmond, Virginia 23219
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Rochester, New York 14609
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Saint Louis, Missouri 63110
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Saint Peters, Missouri 63376
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Salt Lake City, Utah 84132
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San Antonio, Texas 78224
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Sandy Springs, Georgia 30328
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Santa Monica, California 90404
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Syracuse, New York 13210
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Topeka, Kansas 66606
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