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Glucagon-like peptide-1 receptor agonist

Tirzepatide for 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 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%
Must not have
Have a history of chronic or acute pancreatitis
Have undergone or plan to undergo weight reduction procedure during the study, such as gastric bypass, sleeve gastrectomy, restrictive bariatric surgery (e.g. Lap-Band gastric banding), or any other procedure intended to result in weight reduction.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 72
Awards & highlights

Summary

This trial is testing a weight-loss medication called tirzepatide in teenagers who are overweight or obese and have other health problems related to their weight. The study will last about two years and involve multiple visits. Tirzepatide is effective in treating obesity in patients with and without diabetes.

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%.
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.
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
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I am overweight according to BMI charts for my age and sex, and I have a weight-related health issue.
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I have Type 2 Diabetes, treated with diet, exercise, or metformin, and my HbA1c is below 9.0%.
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My BMI is in the top 5% for my age and sex.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of pancreatitis.
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I have had or plan to have surgery to help me lose weight.
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I have not started puberty.
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I have a history of medullary thyroid cancer or MEN syndrome type 2 in my family or myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 72
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 72 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) 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%
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

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
~7520

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
Common treatments for obesity, such as Tirzepatide, work by targeting hormonal pathways that regulate appetite and glucose metabolism. Tirzepatide is a dual agonist for GIP and GLP-1 receptors, which enhances insulin secretion, reduces glucagon levels, and slows gastric emptying, leading to reduced appetite and increased satiety. Other GLP-1 receptor agonists function similarly by mimicking the incretin hormones, which help to control blood sugar levels and reduce food intake. These mechanisms are important for obesity patients as they address both weight loss and metabolic health, providing a comprehensive approach to treatment.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,640 Previous Clinical Trials
3,221,494 Total Patients Enrolled
60 Trials studying Obesity
52,437 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,358 Previous Clinical Trials
417,940 Total Patients Enrolled
42 Trials studying Obesity
31,979 Patients Enrolled for Obesity
~100 spots leftby Oct 2026
Unbiased ResultsWe believe in providing patients with all the options.
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