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Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist

Tirzepatide for Pediatric Obesity

Phase 1
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female participants with body mass index (BMI) ≥ the 95th percentile for age and sex
Female participants only: Determined as prepubertal Tanner Stage 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to 168 hours postdose
Awards & highlights

Study Summary

This trial will analyze safety and tolerability of tirzepatide in kids w/ obesity. Blood tests will investigate how body processes drug. Study lasts 13 wks (not inc. screen).

Who is the study for?
This trial is for children with obesity, defined as having a BMI ≥ the 95th percentile for their age and sex. They should have tried losing weight through lifestyle changes without success. Girls must be in early puberty (Tanner Stage 1). It's not for those with certain medical conditions like pancreatitis, other causes of obesity, diabetes, or significant recent weight change.Check my eligibility
What is being tested?
The study tests Tirzepatide (LY3298176) against a placebo to see how safe it is and how well kids tolerate it. Researchers will also check how the body handles this drug over about 13 weeks, excluding screening time.See study design
What are the potential side effects?
While specific side effects in pediatric participants are being studied, tirzepatide in adults can cause stomach issues like nausea or vomiting, decreased appetite, diarrhea; potential risk of low blood sugar; and possible injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is in the top 5% for my age and sex.
Select...
I am a female and have not started puberty.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 168 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 168 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Secondary outcome measures
PK: Maximum Concentration (Cmax) of Tirzepatide
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032
40%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Gastroenteritis
11%
Vomiting
9%
Flatulence
9%
Abortion induced
7%
Amylase increased
7%
Lipase increased
7%
Abdominal pain upper
7%
Gingivitis
6%
Abdominal pain
6%
Injection site reaction
6%
Menstruation irregular
4%
Hyperuricaemia
4%
Hepatic function abnormal
3%
Vaginal infection
3%
Dizziness
3%
Uterine polyp
1%
Hiccups
1%
Supraventricular tachycardia
1%
Hand fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
Placebo
15 mg Tirzepatide

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TirzepatideExperimental Treatment1 Intervention
Tirzepatide administered subcutaneously (SC)
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered SC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7590

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,605 Previous Clinical Trials
3,199,402 Total Patients Enrolled
52 Trials studying Obesity
40,730 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,338 Previous Clinical Trials
403,777 Total Patients Enrolled
35 Trials studying Obesity
20,449 Patients Enrolled for Obesity

Media Library

Tirzepatide (Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05696847 — Phase 1
Obesity Research Study Groups: Tirzepatide, Placebo
Obesity Clinical Trial 2023: Tirzepatide Highlights & Side Effects. Trial Name: NCT05696847 — Phase 1
Tirzepatide (Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05696847 — Phase 1
Obesity Patient Testimony for trial: Trial Name: NCT05696847 — Phase 1

Frequently Asked Questions

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

To whom does this clinical trial offer access?

"This medical trial seeks to enrol 30 individuals aged between 6 and 11 who are confronting obesity. Specifically, the study requires both male and female participants with a body weight of at least 50 kilogram (kg) for cohort 1 or below that limit for cohorts 2 & 3; plus their BMI must exceed the 95th percentile according to age and gender."

Answered by AI

Is there an open enrollment window for this research endeavor?

"According to clinicaltrials.gov, this particular trial is unfortunately no longer accepting applications as the last update was on January 17th 2023. However, there are other 922 studies presently recruiting candidates."

Answered by AI

Does this trial accept participants aged 85 or over?

"This clinical trial is only open to individuals aged 6-11. However, there are 194 studies for minors and 578 trials for seniors within the same field of medicine."

Answered by AI

Are there any potential risks associated with Tirzepatide use?

"Due to limited clinical evidence, our team at Power gauged the safety of Tirzepatide a score of 1. This medication is still in its first phase trial."

Answered by AI

Who else is applying?

What state do they live in?
Texas
California
What site did they apply to?
Lynn Health Science Institute
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve heard some positive results using the injections Ter… for losing weight. I am wondering if I qualify for this study, having some of the qualifications noted.
PatientReceived 2+ prior treatments
I am obese and have tried diet medications, Atkins , other food plans and exercise without results. I now have chronic knee pain. I am hoping this trial will my make me healthier.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

~10 spots leftby Nov 2024