Your session is about to expire
← Back to Search
Glucagon-like peptide-1 receptor agonist
Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT Trial)
Phase 3
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 52, week 104
Awards & highlights
Pivotal Trial
Summary
This trial is testing whether an injection of semaglutide can lower the risk of heart problems in people who are overweight or obese and have had heart issues before. Participants will receive the real medicine, and the study will last several years with periodic check-ups. Semaglutide has been shown to help with weight loss and improve blood sugar levels in individuals with type 2 diabetes and obesity.
Eligible Conditions
- Obesity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 52, week 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 52, week 104
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke
Secondary study objectives
Change From Randomisation (Week 0) in PRO: EuroQol Five Dimensions Visual Analogue Scale (EQ-5D-VAS) to Week 104
Change From Randomisation (Week 0) in Participant Reported Outcome (PRO): EuroQol Five Dimensions Five Level Questionnaire (EQ-5D-5L) Index Score to Week 104
Change in Body Weight
+25 moreSide effects data
From 2020 Phase 4 trial • 104 Patients • NCT0418984821%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
Participants will receive semaglutide as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months.
Group II: Placebo (semaglutide)Placebo Group1 Intervention
Participants will receive placebo (semaglutide) as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,560 Previous Clinical Trials
3,628,903 Total Patients Enrolled
157 Trials studying Obesity
126,596 Patients Enrolled for Obesity
Clinical Reporting Anchor and Disclosure (1452)Study DirectorNovo Nordisk A/S
104 Previous Clinical Trials
85,654 Total Patients Enrolled
28 Trials studying Obesity
26,029 Patients Enrolled for Obesity
Clinical Transparency (dept.2834)Study DirectorNovo Nordisk A/S