CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 304 enrolled
Drug / intervention
Semaglutide +1 moredrug
Likely dose
Semaglutide 0.25 mgfrom 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/NCT03693430
NCT03693430Phase 3Completed

Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity

Novo Nordisk A/S·interventional·Posted Oct 3, 2018·Updated Jul 6, 2023

In Brief

A Phase 3 clinical trial evaluating Semaglutide and Placebo (Semaglutide) for Overweight and Obesity. Completed, enrolled 304 participants across 41 sites in 5 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight, Obesity
CountriesCanada, Hungary, Italy, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 3, 2018
Enrollment StartOct 5, 2018
Primary CompletionJan 29, 2021
Study CompletionMar 23, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.7 years ago

Interventions

Semaglutidedrug

Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks

Placebo (Semaglutide)drug

S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks