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

Completed · Phase 3 · Has a placebo group

Conditions studied: Metabolism and Nutrition Disorder, Obesity

In brief

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.

Key facts

Study ID

NCT03548987

Run by

Novo Nordisk A/S

People needed

902

Starts

2018-06-04

Expected to finish

2020-03-20

Last updated by the study team

2022-01-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Fresno, California, United States
• Novo Nordisk Investigational Site — San Diego, California, United States
• Novo Nordisk Investigational Site — Alpharetta, Georgia, United States
• Novo Nordisk Investigational Site — Roswell, Georgia, United States
• Novo Nordisk Investigational Site — Suwanee, Georgia, United States
• Novo Nordisk Investigational Site — Louisville, Kentucky, United States
• Novo Nordisk Investigational Site — Baton Rouge, Louisiana, United States
• Novo Nordisk Investigational Site — Elkridge, Maryland, United States
• Novo Nordisk Investigational Site — Buckley, Michigan, United States
• Novo Nordisk Investigational Site — Omaha, Nebraska, United States
• Novo Nordisk Investigational Site — New York, New York, United States
• Novo Nordisk Investigational Site — Greensboro, North Carolina, United States
• Novo Nordisk Investigational Site — Greenville, North Carolina, United States
• Novo Nordisk Investigational Site — Raleigh, North Carolina, United States
• Novo Nordisk Investigational Site — Salisbury, North Carolina, United States
• Novo Nordisk Investigational Site — Cincinnati, Ohio, United States
• Novo Nordisk Investigational Site — Dayton, Ohio, United States
• Novo Nordisk Investigational Site — Bristol, Tennessee, United States
• Novo Nordisk Investigational Site — Bristol, Tennessee, United States
• Novo Nordisk Investigational Site — Chattanooga, Tennessee, United States
• Novo Nordisk Investigational Site — Austin, Texas, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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