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 |
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.
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
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