STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

Conditions

• Metabolism and Nutrition Disorder
• Overweight or Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Semaglutide — DRUG
  Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks. Dose escalation of semaglutide will take place as follows: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 68.
• Placebo (semaglutide) — DRUG
  Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks.

Study Details

This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get, 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 has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.

Key Dates

Start date

Jun 4, 2018

Status verified

Nov 2021

Primary completion

Mar 30, 2020

Completion

Mar 5, 2021

Study Design

Enrollment

1,961 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide s.c. 2.4 mg once weekly
  Participants will receive semaglutide for 68 weeks.
• Placebo Comparator: Semaglutide placebo
  Participants will receive semaglutide matching placebo for 68 weeks.

Primary Outcome Measure

Change in Body Weight (%) [ Time Frame: Baseline (week 0) to week 68 ]

Locations (39)

Find similar trials in Anniston, AL

Related Studies

• Promote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to Prevent Mobility Loss
  Recruiting · Northwestern University · Chicago, Illinois
• Better Lifestyle Counseling for African American Women During Pregnancy
  Recruiting · University of Illinois at Chicago · Chicago, Illinois
• NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks
  Recruiting · Wake Forest University Health Sciences · Winston-Salem, North Carolina
• Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity)
  PHASE2 · Recruiting · Memorial Sloan Kettering Cancer Center · New York, New York