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Glucagon-like peptide-1 receptor agonist

Semaglutide 2.4 mg for Obesity (STEP 10 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
BMI greater than or equal to 30.0 kg/m^2
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomisation (week 0) to end of treatment (week 52)
Awards & highlights

STEP 10 Trial Summary

This trial is studying whether semaglutide can help people with obesity and prediabetes lose weight and improve their blood sugar.

Eligible Conditions
  • Obesity

STEP 10 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a body mass index (BMI) of 30 or higher.

STEP 10 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomisation (week 0) to end of treatment (week 52)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomisation (week 0) to end of treatment (week 52) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in body weight
Change to normoglycemia (Normoglycemia is defined as having both HbA1c below 6.0% (below 42 mmol/mol) and FPG below 5.5 mmol/L (below 99 mg/dL)
Secondary outcome measures
Change in FPG (fasting plasma glucose)
Change in HbA1c (glycated haemoglobin)
Change in lipids - High density lipoprotein (HDL) cholesterol
+6 more

Side effects data

From 2020 Phase 3 trial • 1210 Patients • NCT03552757
32%
Nausea
22%
Diarrhoea
13%
Constipation
13%
Vomiting
12%
Nasopharyngitis
9%
Upper respiratory tract infection
8%
Headache
7%
Back pain
7%
Decreased appetite
7%
Dyspepsia
6%
Arthralgia
5%
Fatigue
5%
Flatulence
5%
Gastroenteritis
2%
Abdominal distension
1%
Abdominal pain
1%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Semaglutide 1.0 mg
Semaglutide 2.4 mg
Placebo

STEP 10 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
Participants will receive subcutaneus (s.c.) semaglutide 2.4 mg once weekly for 52 weeks
Group II: Placebo (semaglutide)Placebo Group1 Intervention
Participants will receive subcutaneus (s.c.) placebo (semaglutide) once weekly for 52 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide 2.4 mg
2021
Completed Phase 3
~1640

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,884 Total Patients Enrolled
141 Trials studying Obesity
131,857 Patients Enrolled for Obesity
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
44,939 Total Patients Enrolled
10 Trials studying Obesity
18,197 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Semaglutide 2.4 mg taken as a preventative measure or to treat an existing condition?

"Semaglutide 2.4 mg is a medication used to manage chronic weight and other conditions related to obesity, such as comorbid conditions, that diet and exercise alone may not improve."

Answered by AI

Are there still positions open for this clinical research?

"According to the latest information from clinicaltrials.gov, this particular trial is not currently seeking patients. The trial was first posted on September 6th, 2021 and was last updated on March 22nd, 2022. Although this study is not presently looking for volunteers, there are 1193 other trials that are."

Answered by AI

What purpose does this clinical trial serve?

"The primary outcome variable that the study's sponsor, Novo Nordisk A/S, is measuring is change in body weight over the course of the 52 weeks of the study. Additionally, this research is looking at secondary outcome measures like change in glycated haemoglobin (HbA1c), triglycerides, and total cholesterol, all of which will be measured as percentages."

Answered by AI

What are the risks associated with Semaglutide 2.4 mg treatments?

"Semaglutide 2.4 mg is in Phase 3 of clinical trials, meaning that there is both efficacy data and multiple rounds of safety data supporting its use."

Answered by AI

Is this a new approach to this particular disease?

"Semaglutide 2.4 mg was first studied in 2018 by Novo Nordisk A/S. After the positive results of the initial study involving 1387 patients, Semaglutide 2.4 mg was approved for Phase 4 drug trials. Currently, there are 59 active trials in 55 countries and 711 cities."

Answered by AI

Is Semaglutide 2.4 mg a common medication that has been tested in other clinical trials?

"Semaglutide 2.4 mg is being trialed in 59 active studies, 27 of which are in Phase 3. Most investigations for Semaglutide 2.4 mg are based in Loma Linda, although there are 3696 total clinical trial locations for Semaglutide 2.4 mg."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes
2021. "Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05040971.
~51 spots leftby Apr 2025
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