CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 902 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/NCT03548987
NCT03548987Phase 3Completed

Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity Who Have Reached Target Dose During run-in Period

Novo Nordisk A/S·interventional·Posted Jun 7, 2018·Updated Jan 19, 2022

In Brief

A Phase 3 clinical trial evaluating Semaglutide and Placebo for Metabolism and Nutrition Disorder and Obesity. Completed, enrolled 902 participants across 72 sites in 10 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark, Israel, Netherlands, Portugal, South Africa, Spain, Sweden, Switzerland, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 7, 2018
Enrollment StartJun 4, 2018
Primary CompletionFeb 22, 2020
Study CompletionMar 20, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.1 years ago

Interventions

Semaglutidedrug

Subcutaneous (under the skin) injection of semaglutide once-weekly.

Placebodrug

Subcutaneous (under the skin) injection of semaglutide placebo once-weekly.