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

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

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

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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

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