Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program



Status:Active, not recruiting
Conditions:Obesity Weight Loss, Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:12/5/2018
Start Date:August 1, 2018
End Date:May 6, 2020

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Effect and Safety of Semaglutide 2.4 mg Once-weekly as Adjunct to Intensive Behavioural Therapy in Subjects With Overweight or Obesity

This study will look at the change in participant's body weight from the start to the end of
the study. This is to compare the effect on body weight in people taking semaglutide (a new
medicine) and people taking "dummy" medicine. Together with the medicine, the participant
will also be part of an intensive lifestyle program where the participant will have talks
with study staff about healthy food choices, what the participant can do to lose weight and
be more physically active. The participant will either get semaglutide or "dummy" medicine -
which treatment the participant gets is decided by chance. The participant will need to take
1 injection once a week. The study medicine is injected with a thin needle in a skin fold in
the stomach, thigh or upper arm. For the first 2 months the participant will be on a low
calorie diet. The diet is made up of bars, shakes and 1 low calorie pre-prepared meal for
each day. The study will last for about 1.5 years. The participant will have 32 clinic visits
with the study doctor.


Inclusion Criteria: - Male or female, age more than or equal to 18 years at the time of
signing informed consent - Body mass index more than or equal to 30 kg/m^2 or more than or
equal to 27 kg/m^2 with the presence of at least one of the following weight-related
comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea
or cardiovascular disease - History of at least one self-reported unsuccessful dietary
effort to lose body weight Exclusion Criteria: - Hemoglobin A1c more than or equal to 48
mmol/mol (6.5%) as measured by the central laboratory at screening - A self-reported change
in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of
medical records
We found this trial at
41
sites
Escondido, California 92025
84
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Escondido, CA
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Albany, New York 12208
2438
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Albany, NY
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Anaheim, California 92801
16
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Anaheim, CA
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Arlington, Virginia 22206
2277
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Arlington, VA
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Austin, Texas 78731
1212
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Austin, TX
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Birmingham, Alabama 35215
1788
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Birmingham, AL
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Chapel Hill, North Carolina 27599
2194
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Chapel Hill, NC
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Charleston, South Carolina 29407
2180
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Charleston, SC
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Chicago, Illinois 60612
1728
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Chicago, IL
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Cleveland, Ohio 44106
2032
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Cleveland, OH
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Dallas, Texas 75231
1225
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Dallas, TX
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Endwell, New York 13760
2325
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Endwell, NY
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Evanston, Illinois 60201
1728
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Evanston, IL
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Fresno, California 93702
209
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Fresno, CA
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Fullerton, California 92835
14
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Fullerton, CA
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Golden, Colorado 80401
807
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Golden, CO
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Greensboro, North Carolina 27408
2151
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Greensboro, NC
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Hickory, North Carolina 28602
2069
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Hickory, NC
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Honolulu, Hawaii 96814
2572
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Honolulu, HI
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Huntington Beach, California 92648
28
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Jonesboro, Arkansas 72401
1546
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Jonesboro, AR
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Kissimmee, Florida 34744
2188
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Kissimmee, FL
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Knoxville, Tennessee 37938
1922
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Los Angeles, California 90027
16
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Los Angeles, CA
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Montgomery, Alabama 36106
1833
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Montgomery, AL
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Mount Pleasant, South Carolina 29464
2188
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Mount Pleasant, SC
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Nashville, Tennessee 37203
1762
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Newport News, Virginia 23606
2328
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Newport News, VA
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Olympia, Washington 98502
931
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Olympia, WA
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Panama City, Florida 32401
1904
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Panama City, FL
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Peoria, Arizona 85381
333
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Peoria, AZ
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Philadelphia, Pennsylvania 19104
2373
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Philadelphia, PA
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Plantation, Florida 33324
2308
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Plantation, FL
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Raleigh, North Carolina 27610
2218
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Raleigh, NC
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Roswell, Georgia 30076
1918
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Roswell, GA
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Round Rock, Texas 78681
1208
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Round Rock, TX
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Saint George, Utah 84790
325
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Saint George, UT
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Skokie, Illinois 60077
1724
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Skokie, IL
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Walnut Creek, California 94598
354
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Walnut Creek, CA
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Wilmington, North Carolina 28401
2275
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Wilmington, NC
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Winchester, Virginia 22601
2219
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Winchester, VA
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