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

Use our guide to learn which trials are right for you!

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)
We found this trial at
68
sites
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Anaheim, California 92801
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Arlington, Virginia 22206
?
mi
from
Arlington, VA
Click here to add this to my saved trials
Athens, Georgia 30606
?
mi
from
Athens, GA
Click here to add this to my saved trials
Aurora, Colorado 80010
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Aurora, Illinois 60506
?
mi
from
Aurora, IL
Click here to add this to my saved trials
Austin, Texas 78731
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21229
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baton Rouge, Louisiana 70808
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Beaver, Pennsylvania 15009
?
mi
from
Beaver, PA
Click here to add this to my saved trials
Birmingham, Alabama 35215
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boynton Beach, Florida 33472
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Bradenton, Florida 34201
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
Bristol, Tennessee 37620
?
mi
from
Bristol, TN
Click here to add this to my saved trials
Canal Fulton, Ohio 44614
?
mi
from
Canal Fulton, OH
Click here to add this to my saved trials
Cary, North Carolina 27518
?
mi
from
Cary, NC
Click here to add this to my saved trials
Charleston, South Carolina 29407
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Ciudad Autónoma de Bs As,
?
mi
from
Ciudad Autónoma de Bs As,
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Concord, California 94520
?
mi
from
Concord, CA
Click here to add this to my saved trials
Crystal River, Florida 34429
?
mi
from
Crystal River, FL
Click here to add this to my saved trials
Daytona Beach, Florida 32117
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
Dunwoody, Georgia 30338
?
mi
from
Dunwoody, GA
Click here to add this to my saved trials
Elkridge, Maryland 21075
?
mi
from
Elkridge, MD
Click here to add this to my saved trials
Eugene, Oregon 97401
?
mi
from
Eugene, OR
Click here to add this to my saved trials
Franklin, Ohio 45005
?
mi
from
Franklin, OH
Click here to add this to my saved trials
Golden, Colorado 80401
?
mi
from
Golden, CO
Click here to add this to my saved trials
Greer, South Carolina 29651
?
mi
from
Greer, SC
Click here to add this to my saved trials
Henrico, Virginia 23233
?
mi
from
Henrico, VA
Click here to add this to my saved trials
Huntington Beach, California 92648
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Jacksonville, Florida 32207
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Kansas City, Missouri 64106
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Milwaukee, Wisconsin 53209
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
New London, Connecticut 06320
?
mi
from
New London, CT
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
North Dartmouth, Massachusetts 02747
?
mi
from
North Dartmouth, MA
Click here to add this to my saved trials
Ocala, Florida 34471
?
mi
from
Ocala, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85053
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15224
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Ponte Vedra, Florida 32081
?
mi
from
Ponte Vedra, FL
Click here to add this to my saved trials
Raleigh, North Carolina 27610
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Renton, Washington 98057
?
mi
from
Renton, WA
Click here to add this to my saved trials
Richmond, Virginia 23219
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rochester, New York 14609
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Peters, Missouri 63376
?
mi
from
Saint Peters, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78224
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92111
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Sandy Springs, Georgia 30328
?
mi
from
Sandy Springs, GA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
South Miami, Florida 33143
?
mi
from
South Miami, FL
Click here to add this to my saved trials
Staten Island, New York 10301
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
Sugar Land, Texas 77479
?
mi
from
Sugar Land, TX
Click here to add this to my saved trials
Suwanee, Georgia 30024
?
mi
from
Suwanee, GA
Click here to add this to my saved trials
Syracuse, New York 13210
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Topeka, Kansas 66606
?
mi
from
Topeka, KS
Click here to add this to my saved trials
Tulsa, Oklahoma 74135
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Virginia Beach, Virginia 23454
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
Wadsworth, Ohio 44281
?
mi
from
Wadsworth, OH
Click here to add this to my saved trials
Washington, District of Columbia 20011
?
mi
from
Washington,
Click here to add this to my saved trials
Waterbury, Connecticut 06708
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
Wenatchee, Washington 98801
?
mi
from
Wenatchee, WA
Click here to add this to my saved trials
West Jordan, Utah 84088
?
mi
from
West Jordan, UT
Click here to add this to my saved trials
West Reading, Pennsylvania 19611
?
mi
from
West Reading, PA
Click here to add this to my saved trials