CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 17,604 enrolled
Drug / intervention
Semaglutide +1 moredrug
Likely dose
Semaglutide 0.24 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/NCT03574597
NCT03574597Phase 3Completed
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SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity

Novo Nordisk A/S·interventional·Posted Jul 2, 2018·Updated Aug 30, 2024

In Brief

A Phase 3 clinical trial evaluating Semaglutide and Placebo (semaglutide) for Overweight and Obesity. Completed, enrolled 17,604 participants across 833 sites in 42 countries.

Detailed Summary

The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight, Obesity
CountriesAlgeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 2, 2018
Enrollment StartOct 24, 2018
Primary CompletionJun 21, 2023
Study CompletionJun 29, 2023
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 8 years ago

Interventions

Semaglutidedrug

Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Subjects will start semaglutide treatment at 0.24 mg; dose will gradually be increased every 4 weeks up to 2.4 mg.

Placebo (semaglutide)drug

Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Participants will receive placebo at an equivalent dose to semaglutide.