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Glucagon-like peptide-1 receptor agonist

Liraglutide for Childhood Obesity

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
Tanner stage 1-5 pubertal development at the time of signing informed consent
Male or female, aged 6 to below 12 years at the time of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to week 82
Awards & highlights

Study Summary

This trial is testing whether liraglutide helps children with obesity lose weight. Children will be randomly assigned to receive either liraglutide or a placebo, and researchers will track how much weight the children lose and if there are any side effects.

Who is the study for?
This trial is for children aged 6 to below 12 with obesity, who haven't had significant weight changes in the last 3 months and have not been on obesity medication recently. They should be struggling to lose weight through lifestyle changes alone. Children with type 2 diabetes can join if their HbA1c levels are low enough.Check my eligibility
What is being tested?
Researchers are testing Liraglutide, a new medicine for kids' weight loss, against a placebo (a treatment with no active drug). Participants will receive daily injections and guidance on healthy living over nearly two years, including clinic visits and remote check-ins.See study design
What are the potential side effects?
Possible side effects of Liraglutide may include digestive issues like nausea or vomiting, appetite changes, risk of hypoglycemia (especially if diabetic), headache, fatigue, or allergic reactions at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at any stage of puberty.
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I am between 6 and 11 years old.
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My BMI is in the top 5% for my age and gender.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to week 82
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to week 82 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relative change in BMI (Body mass index)
Secondary outcome measures
BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov)
Change in BMI standard deviation score (WHO.int)
Change in HbA1c (glycated haemoglobin)
+8 more

Side effects data

From 2017 Phase 4 trial • 100 Patients • NCT02014740
29%
nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Liraglutide
Metformin

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Liraglutide 3.0 mgExperimental Treatment1 Intervention
The treatment duration is 56 weeks and the follow-up period is 26 weeks.
Group II: PlaceboPlacebo Group1 Intervention
The treatment duration is 56 weeks and the follow-up period is 26 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liraglutide
2013
Completed Phase 4
~2680

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,414,951 Total Patients Enrolled
141 Trials studying Obesity
131,960 Patients Enrolled for Obesity
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
45,042 Total Patients Enrolled
10 Trials studying Obesity
18,300 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
105 Previous Clinical Trials
139,711 Total Patients Enrolled
28 Trials studying Obesity
49,447 Patients Enrolled for Obesity

Media Library

Liraglutide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04775082 — Phase 3
Obesity Research Study Groups: Placebo, Liraglutide 3.0 mg
Obesity Clinical Trial 2023: Liraglutide Highlights & Side Effects. Trial Name: NCT04775082 — Phase 3
Liraglutide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04775082 — Phase 3
Obesity Patient Testimony for trial: Trial Name: NCT04775082 — Phase 3

Frequently Asked Questions

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

How many people total will be participating in this research project?

"Obesity clinical trials are currently recruiting 998 participants while Liraglutide clinical trials are actively enrolling 36 patients. This particular study, however, is not presently looking for volunteers. The trial was initially posted on 3/4/2021 and last updated on 11/10/2022."

Answered by AI

Could you explain the risks associated with taking Liraglutide?

"Liraglutide is considered safe, as it has received a score of 3. This is due to the fact that this medication has entered Phase 3 clinical trials, meaning there is significant data supporting its efficacy and safety."

Answered by AI

What are some of the main conditions that Liraglutide has been known to improve?

"Patients that commonly use liraglutide do so as part of an exercise regime. However, this medication can also help those who have unsuccessfully tried monotherapy and those suffering from cardiovascular disease or risks thereof."

Answered by AI

Are there any available appointments for this research program?

"The latest information available on clinicaltrials.gov indicates that this study is not recruiting patients at the moment. The listing was first posted on March 4th, 2021 and updated November 10th, 2022. While subjects are not being recruited for this trial, there are 1,034 other studies currently looking for volunteers."

Answered by AI

How can I join this clinical trial?

"The current recruitment goal for this clinical trial is 78 children, aged 6 to 12 years old, that suffer from obesity. To qualify, patients must meet the following body mass index criteria: their BMI must be equal to or greater than the 95th percentile when compared against gender and age-specific growth charts (CDC.gov)."

Answered by AI

Are there other examples of drugs similar to Liraglutide that have been trialed?

"UBMD Pediatrics, Division of Pediatric Endocrinology first studied liraglutide in 2012. Since then, a total of 18519 completed studies have been conducted worldwide. There are currently 36 clinical trials recruiting patients actively, with many of these taking place in Dayton, Ohio."

Answered by AI

How many staff members are managing this clinical trial today?

"Patients are encouraged to select the clinical trial site nearest them to minimize travel as this study is being conducted at 7 different locations. The sites are situated in cities including Dayton, Pittsburgh and Baton Rouge among others."

Answered by AI

Are elderly patients within the age limit for this experiment?

"The pool of potential participants for this clinical trial must, at a minimum, be 6 years old but not older than 12."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
New York
Other
Ohio
How old are they?
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2

Why did patients apply to this trial?

I have tried one other drug w diet and excersize w little losses.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity
2021. "SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04775082.
All > Saxenda > Victoza
~19 spots leftby Apr 2025
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