← Back to Search

Glucagon-like peptide-1 receptor agonist

Tirzepatide for Obesity

Q: For which demographic is this clinical trial ideally suited?

This research project is accepting up to 150 adolescent candidates with <a href="https://www.withpower.com/clinical-trials/obesity">obesity</a> between 12 and 17 years of age.

Q: Are geriatric participants eligible to partake in this trial?

This trial is only open to adolescent participants aged between 12 and 17, in adherence with the specified inclusion criteria.

Q: To what extent does Tirzepatide pose a hazard to individuals?

Tirzepatide is considered to be a relatively safe drug, garnering a score of 3 on our team's safety scale. This assessment is largely based on the pre-existing Phase 3 clinical data which demonstrate both its efficacy and low risk profile.

Q: Are there any remaining slots for participants in this experiment?

Data from clinicaltrials.gov points to this trial no longer recruiting participants, though it was initially posted on October 15th 2023 and updated as recently as October 4th 2023. Fortunately, there are over a thousand other studies that currently have open enrolment for patients looking to participate in medical trials.

Q: How many sites are responsible for overseeing this trial?

This trial is being administered at 36 different medical sites, such as CenExel iResearch in Decatur, Cotton O'Neil Clinical Research Center in Topeka and Pennington Biomedical Research Centre in Baton Rouge.

Phase 3

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

Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity (dyslipidemia, pre-hypertension, hypertension, nonalcoholic fatty liver disease, obstructive sleep apnea, prediabetes, documented preexisting condition of Type 2 Diabetes)

Participants with Type 2 Diabetes Mellitus (T2DM) who have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c<9.0%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 72

Awards & highlights

Study Summary

This trial will evaluate the safety and effectiveness of a drug for adolescents with obesity and related conditions. It will last 90 weeks with up to 25 visits.

Who is the study for?

This trial is for adolescents with obesity (BMI ≥95th percentile) or overweight with weight-related issues like high cholesterol, high blood pressure, liver disease, sleep apnea, or prediabetes. Those treated for Type 2 Diabetes with diet/exercise or metformin can join if their HbA1c is below 9.0%.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of Tirzepatide, a medication given once weekly to help manage obesity in teens. It's compared against a placebo over about 90 weeks and includes up to 25 visits to check progress.See study design

What are the potential side effects?

Possible side effects of Tirzepatide may include digestive problems like nausea or diarrhea, potential low blood sugar levels especially in those also taking diabetes medications, and possibly thyroid tumors.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am overweight according to BMI charts for my age and sex, and I have a weight-related health issue.

Select...

I have Type 2 Diabetes, treated with diet, exercise, or metformin, and my HbA1c is below 9.0%.

Select...

My BMI is in the top 5% for my age and sex.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 72

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 72

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 72 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percent Change from Baseline in Body Mass Index (BMI)

Secondary outcome measures

Change from Baseline in Body Weight

Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts

Change from Baseline in Diastolic Blood Pressure

+8 more

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

Abortion induced

Flatulence

Abdominal pain upper

Gingivitis

Amylase increased

Lipase increased

Injection site reaction

Menstruation irregular

Abdominal pain

Hepatic function abnormal

Hyperuricaemia

Uterine polyp

Dizziness

Vaginal infection

Supraventricular tachycardia

Hand fracture

Hiccups

100%

80%

60%

40%

20%

Study treatment Arm

10 mg Tirzepatide

15 mg Tirzepatide

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TirzepatideExperimental Treatment1 Intervention

Participants will receive tirzepatide subcutaneously (SC).

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tirzepatide

2019

Completed Phase 3

~5780

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,620 Previous Clinical Trials

3,216,449 Total Patients Enrolled

55 Trials studying Obesity

51,069 Patients Enrolled for Obesity

Study DirectorEli Lilly and Company

1,348 Previous Clinical Trials

415,595 Total Patients Enrolled

38 Trials studying Obesity

30,788 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.

For which demographic is this clinical trial ideally suited?

"This research project is accepting up to 150 adolescent candidates with obesity between 12 and 17 years of age."

Answered by AI

Are geriatric participants eligible to partake in this trial?

"This trial is only open to adolescent participants aged between 12 and 17, in adherence with the specified inclusion criteria."

Answered by AI

To what extent does Tirzepatide pose a hazard to individuals?

"Tirzepatide is considered to be a relatively safe drug, garnering a score of 3 on our team's safety scale. This assessment is largely based on the pre-existing Phase 3 clinical data which demonstrate both its efficacy and low risk profile."

Answered by AI

Are there any remaining slots for participants in this experiment?

"Data from clinicaltrials.gov points to this trial no longer recruiting participants, though it was initially posted on October 15th 2023 and updated as recently as October 4th 2023. Fortunately, there are over a thousand other studies that currently have open enrolment for patients looking to participate in medical trials."

Answered by AI

How many sites are responsible for overseeing this trial?

"This trial is being administered at 36 different medical sites, such as CenExel iResearch in Decatur, Cotton O'Neil Clinical Research Center in Topeka and Pennington Biomedical Research Centre in Baton Rouge."

Answered by AI

Who else is applying?

What site did they apply to?

CenExel iResearch, LLC

Pennington Biomedical Research Center

Other

Solaris Clinical Research

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

Why did patients apply to this trial?

Ive tried every avenue to lose weight. I suffer from PCOS and Insulin resistance. I would love to see how this medication can benefit my life long term.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

2023. "A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06075667.

All > Kansas City > Overweight