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Glucagon-like peptide-1 receptor agonist

Liraglutide for Post-Sleeve Gastrectomy Obesity in Adolescents

Phase 2

Waitlist Available

Led By Jack A Yanovski, M.D.

Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to take subcutaneous medication and be willing to adhere to the daily subcutaneous liraglutide regimen

12 months or more status-post vertical sleeve gastrectomy with a maximum of 10 years after surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

Study Summary

This trial is testing whether liraglutide can help adolescents who still have obesity 1 year or more after vertical sleeve gastrectomy lose additional weight. Eligible participants must be between 12-20.99 years old, 1-10 years post vertical sleeve gastrectomy, and have a BMI of 30 kg/m2 or >=95th percentile for age and sex. The trial will last 7 months and involve 7 study visits.

Who is the study for?

This trial is for healthy adolescents aged 12-20.99 who are 1-10 years post vertical sleeve gastrectomy with a BMI of ≥30 kg/m2 or ≥95th percentile for their age and sex. They must be willing to take daily injections of liraglutide, not use weight loss medications, insulin, or certain other drugs affecting insulin secretion recently.Check my eligibility

What is being tested?

The study tests if the drug liraglutide can help adolescents lose additional weight after having had sleeve gastrectomy surgery at least a year prior. Participants will inject themselves with liraglutide daily for 16 weeks and attend seven study visits over seven months.See study design

What are the potential side effects?

Liraglutide may cause digestive issues like nausea or vomiting, low blood sugar levels (hypoglycemia), headaches, decreased appetite, fatigue, and possible risk of pancreatitis or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take medication under the skin and will follow the daily liraglutide regimen.

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I had sleeve gastrectomy surgery between 1 and 10 years ago.

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My BMI is 30 or higher, or it's in the top 5% for my age and sex.

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I am between 12 and 20 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in BMI

Change in Fat Mass

Side effects data

From 2017 Phase 4 trial • 100 Patients • NCT02014740

29%

nausea

100%

80%

60%

40%

20%

Study treatment Arm

Liraglutide

Metformin

Trial Design

1Treatment groups

Experimental Treatment

Group I: LiraglutideExperimental Treatment1 Intervention

Treated with Liraglutide

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Liraglutide

2013

Completed Phase 4

~2680

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor

1,963 Previous Clinical Trials

2,674,720 Total Patients Enrolled

104 Trials studying Obesity

97,051 Patients Enrolled for Obesity

Jack A Yanovski, M.D.Principal InvestigatorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

23 Previous Clinical Trials

7,247 Total Patients Enrolled

14 Trials studying Obesity

3,888 Patients Enrolled for Obesity

Media Library

Liraglutide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04883346 — Phase 2

Obesity Research Study Groups: Liraglutide

Obesity Clinical Trial 2023: Liraglutide Highlights & Side Effects. Trial Name: NCT04883346 — Phase 2

Liraglutide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04883346 — Phase 2

Frequently Asked Questions

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

What criteria must be met for individuals to participate in this research project?

"This study is seeking 50 participants aged 12 to 20 with obesity as a criterion for enrollment."

Answered by AI

Are participants over two decades of age eligible for inclusion in this research?

"The research necessitates that participants must be within the age range of 12 to 20. Notably, 209 trials cater to those under 18 years old and 620 for patients aged above 65."

Answered by AI

How many enrollees are being taken into this clinical study?

"Yes, the data on clinicaltrials.gov reveals that this research is actively enrolling participants. It was initially posted in June 2021 and has since been updated multiple times, with its most recent update occurring in September 2022. The study hopes to recruit 50 people from a single site."

Answered by AI

Could you please provide information regarding the current enrollment status of this trial?

"The clinicaltrials.gov website shows that this study is actively recruiting, having been originally posted on June 21st 2021 and last edited on September 14th 2022."

Answered by AI

What is the common purpose of Liraglutide administration?

"Liraglutide is often given to treat physical exertion and can be used in cases of inadequate response with monotherapy, reducing the risk of cardiovascular diseases and treating existing CVDs."

Answered by AI

Has Liraglutide received authorization from the U.S. Food and Drug Administration?

"The safety of liraglutide was rated a 2 based on the preliminary data evaluating its utility, as this is classified as a Phase 2 trial with some evidence to support safety but no proof of efficacy."

Answered by AI