Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

• Status: Completed
• Trial end date: 2020-03-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

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