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

• Status: Completed
• Trial end date: 2021-03-23
• Target enrollment: 0
• Participant gender: All

Summary

This study will look at the change in body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking "dummy" medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. 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 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor.

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

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• Male or female, age more than or equal to 18 years at the time of signing informed consent

• Body mass index (BMI) 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:

• HbA1c 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