Semaglutide for Overweight

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Overweight+1 More
Semaglutide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether the drug semaglutide can reduce the risk of cardiovascular events (like heart attacks or strokes) in people who are overweight or obese and have already had one such event. People taking part will be randomly assigned to either take semaglutide or a placebo (dummy) drug, and neither they nor the researchers will know who is taking which. The trial will last for 2.5 to 5 years, with participants making up to 25 visits to the study doctor.

Eligible Conditions
  • Overweight
  • Obesity

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Overweight

Study Objectives

1 Primary · 28 Secondary · Reporting Duration: Week 0, year 2

0-59 months
Subjects with HbA1c less than 39 mmol/mol (5.7%) at each visit where HbA1c is assessed for subjects with a screening HbA1c greater than or equal to 39 mmol/mol (5.7%)
Time to CV death
Time to HbA1c greater than or equal to 39 mmol/mol (5.7%) for subjects with a screening HbA1c less than 39 mmol/mol (5.7%)
Time to all-cause death
Time to first occurrence of HbA1c greater than or equal to 48 mmol/mol (6.5%)
Time to first occurrence of a 5-component composite nephropathy endpoint
Time to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction, or non-fatal stroke
Time to first occurrence of a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, or non-fatal stroke
Time to first occurrence of a composite heart failure endpoint consisting of: heart failure hospitalisation, urgent heartfailure visit or CV death
Time to first occurrence of an expanded composite CV endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation or unstable angina requiring hospitalisation
Time to first occurrence of coronary revascularisation
Time to first occurrence of heart failure hospitalisation or urgent heart failure visit
Time to first occurrence of non-fatal myocardial infarction
Time to first occurrence of non-fatal stroke
Time to first occurrence of unstable angina requiring hospitalisation
Week 104
Change in HbA1c
Change in haemoglobin A1c (HbA1c)
Week 0, year 2
Change in EuroQol five dimensions five level (EQ-5D-5L) questionnaire
Change in High sensitivity C-Reactive Protein (hsCRP)
Change in body weight
Change in diastolic blood pressure
Change in high density lipoprotein (HDL) cholesterol
Change in low density lipoprotein (LDL) cholesterol
Change in pulse
Change in systolic blood pressure
Change in total cholesterol
Change in total score weight related sign and symptom measure
Change in triglycerides
Change in waist circumference

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Overweight

Side Effects for

Overall Study
21%Nausea
12%Decreased Appetite
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04189848) in the Overall Study ARM group. Side effects include: Nausea with 21%, Decreased Appetite with 12%.

Trial Design

2 Treatment Groups

Semaglutide
1 of 2
Placebo (semaglutide)
1 of 2
Experimental Treatment
Non-Treatment Group

17500 Total Participants · 2 Treatment Groups

Primary Treatment: Semaglutide · Has Placebo Group · Phase 3

Semaglutide
Drug
Experimental Group · 1 Intervention: Semaglutide · Intervention Types: Drug
Placebo (semaglutide)
Drug
PlaceboComparator Group · 1 Intervention: Placebo (semaglutide) · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 0, year 2

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,390 Previous Clinical Trials
2,276,103 Total Patients Enrolled
63 Trials studying Overweight
32,532 Patients Enrolled for Overweight
Clinical Reporting Anchor and Disclosure (1452)Study DirectorNovo Nordisk A/S
104 Previous Clinical Trials
85,696 Total Patients Enrolled
26 Trials studying Overweight
8,570 Patients Enrolled for Overweight

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female, or you are 45 years or older.
You have a body mass index (BMI) greater than or equal to 27 kg/m^2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: October 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas50.0%
New York16.7%
North Carolina16.7%
Other16.7%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
References