Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus



Status:Completed
Conditions:Obesity Weight Loss, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:9/8/2018
Start Date:October 1, 2015
End Date:April 12, 2017

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This trial is conducted globally. The aim of this trial is to investigate safety and efficacy
of once-daily semaglutide in obese subjects without diabetes mellitus.


Inclusion Criteria: - Informed consent obtained before any trial-related activities.
Trial-related activities are any procedures that are carried out as part of the trial,
including activities to determine suitability for the trial - Male or female, age 18 years
or older at the time of signing inform consent - Body mass index (BMI) equal or above 30.0
kg/m^2 at the screening visit - At least one unsuccessful weight loss attempt per
investigator judgement Exclusion Criteria: - A HbA1c (glycosylated haemoglobin) equal to or
above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus - Treatment
with glucose lowering agent(s) within 90 days before screening - Screening calcitonin equal
to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or
multiple endocrine neoplasia syndrome type 2 - History of pancreatitis (acute or chronic) -
Obesity induced by endocrine disorders (e.g. Cushing Syndrome) - Treatment with any
medication within 90 days before screening that based on investigator's judgement may cause
significant weight change - Previous surgical treatment for obesity (liposuction and/or
abdominoplasty performed 1 year before screening is allowed) - History of major depressive
disorder within 2 years before randomisation - Any lifetime history of a suicidal attempt -
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing
potential and not using an adequate contraceptive method (adequate contraceptive measures
as required by local regulation or practice)
We found this trial at
22
sites
Rochester, New York 14609
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Rochester, NY
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Anaheim, California 92801
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Anaheim, CA
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Arlington, Virginia 22206
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Arlington, VA
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Bristol, Tennessee 37620
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Bristol, TN
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Camperdown, New South Wales
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Camperdown,
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Charleston, South Carolina 29407
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from
Charleston, SC
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Cincinnati, Ohio 45229
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from
Cincinnati, OH
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Crystal River, Florida 34429
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from
Crystal River, FL
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Dallas, Texas 75231
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Dallas, TX
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Elkridge, Maryland 21075
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Elkridge, MD
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Golden, Colorado 80401
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Golden, CO
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Greer, South Carolina 29651
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Greer, SC
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Jacksonville, Florida 32207
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from
Jacksonville, FL
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Plantation, Florida 33324
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Plantation, FL
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Portland, Oregon 97239
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Portland, OR
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Richmond, Virginia 23219
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from
Richmond, VA
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Round Rock, Texas 78681
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Round Rock, TX
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San Diego, California 92111
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San Diego, CA
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Sugar Land, Texas 77479
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Sugar Land, TX
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Wadsworth, Ohio 44281
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Wadsworth, OH
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Washington, District of Columbia 20011
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Washington,
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Waterbury, Connecticut 06708
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Waterbury, CT
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