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

Completed · Phase 3 · Has a placebo group

Conditions studied: Overweight, Obesity

In brief

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.

Key facts

Study ID

NCT03693430

Run by

Novo Nordisk A/S

People needed

304

Starts

2018-10-05

Expected to finish

2021-03-23

Last updated by the study team

2023-07-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Birmingham, Alabama, United States
• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — Aurora, Colorado, United States
• Novo Nordisk Investigational Site — Golden, Colorado, United States
• Novo Nordisk Investigational Site — Waterbury, Connecticut, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Ocala, Florida, United States
• Novo Nordisk Investigational Site — City of Saint Peters, Missouri, United States
• Novo Nordisk Investigational Site — Butte, Montana, United States
• Novo Nordisk Investigational Site — Albany, New York, United States
• Novo Nordisk Investigational Site — Rochester, New York, United States
• Novo Nordisk Investigational Site — Kingsport, Tennessee, United States
• Novo Nordisk Investigational Site — Austin, Texas, United States
• Novo Nordisk Investigational Site — Round Rock, Texas, United States
• Novo Nordisk Investigational Site — Arlington, Virginia, United States
• Novo Nordisk Investigational Site — Surrey, British Columbia, Canada
• Novo Nordisk Investigational Site — Moncton, New Brunswick, Canada
• Novo Nordisk Investigational Site — Halifax, Nova Scotia, Canada
• Novo Nordisk Investigational Site — Hamilton, Ontario, Canada
• Novo Nordisk Investigational Site — Hamilton, Ontario, Canada
• Novo Nordisk Investigational Site — Toronto, Ontario, Canada
• Novo Nordisk Investigational Site — Toronto, Ontario, Canada
• Novo Nordisk Investigational Site — Montreal, Quebec, Canada
• Novo Nordisk Investigational Site — Québec, Canada
• Novo Nordisk Investigational Site — Budapest, Hungary

Full record on ClinicalTrials.gov

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