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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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to 168 hours postdose
Awards & highlights

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.

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%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo

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
~5560

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Tirzepatide, a dual GIP and GLP-1 receptor agonist, and other GLP-1 receptor agonists like liraglutide and semaglutide, work by mimicking incretin hormones that are released after eating. These hormones stimulate insulin release, inhibit glucagon secretion, slow gastric emptying, and promote satiety, leading to reduced food intake and weight loss. This is particularly important for obesity patients as these mechanisms help in managing weight and improving metabolic health, thereby reducing the risk of obesity-related complications such as type 2 diabetes and cardiovascular diseases.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,629 Previous Clinical Trials
3,218,080 Total Patients Enrolled
57 Trials studying Obesity
51,795 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,351 Previous Clinical Trials
416,446 Total Patients Enrolled
40 Trials studying Obesity
31,514 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
~4 spots leftby Nov 2024