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Tirzepatide for Adolescent Obesity

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 body mass index (BMI) equal to or above the 95th percentile for age and sex with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes, and hypertriglyceridemia
Be younger than 18 years old
Must not have
Have type 1 diabetes or history of ketoacidosis or hyperosmolar state
Have a history of chronic or acute pancreatitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial aims to see how a drug called tirzepatide affects weight and heart health in obese teenagers with other weight-related health issues. The study will last about 76 weeks and participants may

Who is the study for?
This trial is for adolescents with obesity and weight-related health issues. Participants should be committed to a healthy diet and exercise routine. Details on specific inclusion or exclusion criteria are not provided, but typically these would involve age range, BMI thresholds, and absence of conditions that could interfere with the study.
What is being tested?
The study tests Tirzepatide's effectiveness in reducing body weight and improving heart health risks compared to a placebo. It spans roughly 76 weeks with up to 23 check-ins, where participants will also follow prescribed nutrition and physical activity plans.
What are the potential side effects?
While specific side effects for Tirzepatide in adolescents are not listed here, common ones may include gastrointestinal symptoms like nausea or diarrhea, potential low blood sugar levels, injection site reactions, or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is in the top 5% for my age and sex, and I have at least two conditions like high blood pressure, prediabetes, or high triglycerides.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have type 1 diabetes or have had ketoacidosis or a hyperosmolar state.
Select...
I have a history of pancreatitis.
Select...
I or my family have a history of medullary thyroid cancer or MEN2.
Select...
I have lost more than 5 kg in weight in the last 3 months without trying.
Select...
I have type 2 diabetes or my HbA1c level is above 6.4%.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%
Vomiting
11%
Gastroenteritis
9%
Flatulence
9%
Abortion induced
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Abdominal pain
6%
Injection site reaction
6%
Menstruation irregular
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Vaginal infection
3%
Dizziness
1%
Hand fracture
1%
Supraventricular tachycardia
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Tirzepatide
15 mg Tirzepatide

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7520

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,670 Previous Clinical Trials
3,228,469 Total Patients Enrolled
69 Trials studying Obesity
55,072 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,385 Previous Clinical Trials
426,091 Total Patients Enrolled
51 Trials studying Obesity
34,614 Patients Enrolled for Obesity
~200 spots leftby May 2027
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