NCT03811574

STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity

Effect and Safety of Semaglutide Once-weekly in East Asian Subjects With Overweight or Obesity

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 401 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at the change in participants' 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, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants are three times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm. The study will last for about one and a half years. Participants will have 14 clinic visits and 11 phone calls with the study doctor.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DRUG	Semaglutide	Semaglutide injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.
DRUG	Placebo (semaglutide)	Placebo (semaglutide) injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.

Timeline

• Start date: 2019-01-21
• Primary completion: 2020-11-20
• Completion: 2020-11-20
• First posted: 2019-01-22
• Last updated: 2022-03-22
• Results posted: 2022-03-22

Locations

28 sites across 2 countries: Japan, South Korea

Regulatory

• FDA-regulated drug study