Evaluation of Tirzepatide Versus Placebo in Adolescents with Obesity or Overweight and Weight-Related Comorbidities: A Randomized, Double-Blind Clinical Trial

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Tirzepatide in adolescents who are either overweight or have obesity. The study also includes participants who have additional health issues related to their weight, such as high blood pressure or type 2 diabetes. Tirzepatide is given as a solution for injection, and the trial will compare its effects to those of a placebo. The main goal is to evaluate how safe and effective Tirzepatide is in helping these adolescents manage their weight.

Participants in the study will receive weekly injections of either Tirzepatide or a placebo over a period of 17 weeks. Throughout the study, researchers will monitor changes in the participants’ body mass index (BMI), which is a measure of body fat based on height and weight. The study aims to see if Tirzepatide can help reduce BMI and improve other health conditions related to being overweight or having obesity.

The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving Tirzepatide and who is receiving the placebo. This helps ensure that the results are unbiased. The study is expected to continue until early 2026, with the recruitment of participants starting in late 2023. The findings from this trial could provide valuable insights into the potential benefits of Tirzepatide for adolescents struggling with weight management and related health issues.

Who Can Join the Study?

You must be diagnosed with obesity (having a high amount of body fat) or being overweight (having more body weight than is considered healthy for your height).
You must have at least one comorbidity, which is a medical condition that exists alongside your weight issues, such as abnormal lipids (unhealthy levels of fats like cholesterol in the blood), high blood pressure, fatty liver disease (excess fat buildup in the liver), sleep apnea (breathing problems during sleep), prediabetes, or type 2 diabetes.
You must have been unable to lose weight through healthy diet and physical activity.
If you have type 2 diabetes mellitus (a condition where the body cannot properly control blood sugar), you must have been managing it with only diet and exercise or with a medicine called metformin for at least 90 days before starting the study.
If you have type 2 diabetes, your HbA1c (a blood test that shows your average blood sugar levels over the past few months) must be less than 9.0%.

Who Cannot Join the Study?

You have lost more than 5 kilograms (about 11 pounds) in the 90 days before the study begins.
You have Type 1 Diabetes, which is a condition where the body cannot make its own insulin to control blood sugar.
You have not yet started puberty, which is the period of physical changes when a child’s body develops into an adult body.
You or a family member has a history of medullary thyroid carcinoma, a specific type of cancer that grows in the thyroid gland.
You or a family member has Multiple Endocrine Neoplasia (MEN) Syndrome Type 2, which is a genetic condition that causes tumors to grow in several different parts of the body.
You have a history of pancreatitis, which is an inflammation or swelling of the pancreas.
You have previously had or are planning to have weight loss surgery during the time you are in this study.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Universita’ Degli Studi Di Verona	Verona	Italy
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Nemocnice Jihlava prispevkova organizace	Jihlava	Czechia
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Nemocnice AGEL Ostrava-Vitkovice a.s.	Ostrava	Czechia
Instytut Diabetologii Sp. z o.o.	Warsaw	Poland
ReFit Clinic s.r.o.	Olomouc	Czechia
Anqjwnp Usgwz Svfsfahch Lkxrns Dz Bffrmvd	Bologna	Italy
Spvkqccibrg Pravuofvd Zjmftb Ohudec Zjomqfqsry Civkvxhau Swlugti Klrveuhcg Uwvyxldujiib Mhaexaoeny W Lmhfo	Lodz	Poland
Fejznmzy niawtocpk Mrctp a Hoapqqg	Prague	Czechia
Syhuytmvkiv Pljmxxric Spkpvtf Kjmkqceji Ni 1 Irrjkgxyyrnqxfhcot Syzaibl Scemqynur Uijghnqiayqd Mlqvbmtrlm W Kdcvvjuizp	Zabrze	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	06.11.2023
Italy	Not recruiting	06.11.2023
Poland	Not recruiting	06.11.2023

Trial locations

Investigated drugs:

Tirzepatide

Tirzepatide is an injectable medication that is being tested to see how well it works and how safe it is for teenagers who are overweight or have obesity along with other health issues related to their weight.

Investigated diseases:

Obesity – This condition involves an excessive accumulation of body fat that may impair health. It often develops when an imbalance between calories consumed and calories burned persists over time. As the condition progresses, the amount of stored fat in the body continues to increase. This excess weight is typically measured using body mass index. Overweight – This is a condition where a person has more body weight than what is considered healthy for their height. It serves as a stage that can occur before moving into higher weight categories. The condition occurs when body fat accumulation exceeds the recommended levels. It can progress if weight management habits are not maintained.

Trial ID:

2023-504413-80-00

Protocol code:

I8F-MC-GPHP

Trial Phase:

Therapeutic confirmatory (Phase III)

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Evaluation of Tirzepatide Versus Placebo in Adolescents with Obesity or Overweight and Weight-Related Comorbidities: A Randomized, Double-Blind Clinical Trial

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?