CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 401 enrolled
Drug / intervention
Semaglutide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03811574
NCT03811574Phase 3Completed

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

Novo Nordisk A/S·interventional·Posted Jan 22, 2019·Updated Mar 22, 2022

In Brief

A Phase 3 clinical trial evaluating Semaglutide and Placebo (semaglutide) for Overweight and Obesity. Completed, enrolled 401 participants across 28 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight, Obesity
CountriesJapan, South Korea
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJan 22, 2019
Enrollment StartJan 21, 2019
Primary CompletionNov 20, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.4 years ago

Interventions

Semaglutidedrug

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.

Placebo (semaglutide)drug

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.