Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/6/2018 |
| Start Date: | June 4, 2018 |
| End Date: | March 23, 2020 |
Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity Who Have Reached Target Dose During run-in Period
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. In addition to taking the medicine, the
participant will have talks with study staff about healthy food choices, how to be more
physically active and what a participant can do to lose weight.
The participant will get semaglutide for the first 20 weeks. Then the participant will get
either semaglutide or "dummy" medicine - which treatment the participant gets after the 20
weeks is decided by chance. The participants 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. The study will last for about 1.5 years.
the study. This is to compare the effect on body weight in people taking semaglutide (a new
medicine) and people taking "dummy" medicine. In addition to taking the medicine, the
participant will have talks with study staff about healthy food choices, how to be more
physically active and what a participant can do to lose weight.
The participant will get semaglutide for the first 20 weeks. Then the participant will get
either semaglutide or "dummy" medicine - which treatment the participant gets after the 20
weeks is decided by chance. The participants 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. The study will last for about 1.5 years.
Inclusion Criteria:
- Male or female, age greater than or equal to 18 years at the time of signing informed
consent
- Body mass index greater than or equal to 30 kg/sqm or greater than or equal to 27
kg/sqm 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:
- Haemoglobin A1c greater than or equal to 48 mmol/mol (6.5%) as measured by 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
26
sites
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