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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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation

    After joining the study, tirzepatide or a placebo (an inactive substance that looks like the medicine) is administered.

    The medication is given as a solution for injection using a pre-filled pen.

  2. Step 2

    Medication administration

    The medication, either tirzepatide or the placebo, is administered once weekly.

Who can join the trial?

5 criteria

  • 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 trial?

7 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

  • Tirzepatide

    This medication is administered as a solution through a weekly injection using a pre-filled pen. It is currently used in medical practice to help manage weight and control blood sugar levels. The drug works by mimicking two natural hormones in the body that regulate appetite and digestion, helping to make a person feel full longer. It belongs to a class of drugs known as dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonists.

  • Placebo

    This is an inactive substance administered as a solution via injection to serve as a comparison in the study. It has no medicinal properties and is used in clinical trials to ensure that the results observed are actually caused by the test medication. Because it contains no active ingredients, it does not have a specific mechanism of action or a pharmacological classification.

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 detailsLast updated 15 Oct 2026
Age0-17PhasePhase IIITrial ID2023-504413-80-00Protocol codeI8F-MC-GPHPEstimated enrolment150 patientsSponsorEli Lilly & Co.

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