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Weight-Loss drug tirzepatide put to the test in teens

NCT ID NCT06075667

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study tests whether tirzepatide, a once-weekly injection, helps teenagers with obesity or overweight (with related health issues) lose weight. About 160 teens will receive either tirzepatide or a placebo for 72 weeks, alongside lifestyle advice. The main goal is to see if body mass index (BMI) changes, with additional checks on weight, waist size, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tirzepatide
What this could lead to
If successful, this could offer a new weight-loss option for teens with obesity or weight-related health problems.
What could go wrong
This is a Phase 3 trial, but results may not apply to all teens. Side effects are possible, and long-term safety is still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

160 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR * 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) * 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% Exclusion Criteria: * Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records. * Have Type 1 Diabetes * Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction. * Are prepubertal (Tanner stage 1). * Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2 * Have a history of chronic or acute pancreatitis. * Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to * gastric bypass * sleeve gastrectomy * restrictive bariatric surgery, such as Lap-Band gastric banding, or * any other procedure intended to result in weight reduction.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity Overweight

Contacts and locations

Locations

  • Alberta Diabetes Institute

    Edmonton, Alberta, T6G 2E1, Canada

  • Aventiv Research Inc

    Columbus, Ohio, 43213, United States

  • Azienda Ospedaliera Universitaria Di Messina G. Martino

    Messina, 98125, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

    Verona, Veneto, 37126, Italy

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100, Italy

  • Barry J. Reiner, MD, LLC

    Baltimore, Maryland, 21229, United States

  • CIUSSS- saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec, G7H 5H6, Canada

  • CenExel iResearch, LLC

    Decatur, Georgia, 30030, United States

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Uniwersyteckie Centrum Pediatrii im. M. Konop -T

    Lodz, Łódź Voivodeship, 91-738, Poland

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas, 66606, United States

  • Emek Medical Center

    Afula, Northern District, 1834111, Israel

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34, Czechia

  • Fakultni nemocnice v Motole

    Prague, Praha 5, 150 06, Czechia

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    Bologna, Emilia-Romagna, 40138, Italy

  • Instytut Diabetologii

    Warsaw, Masovian Voivodeship, 02-117, Poland

  • M Health Fairview - Delaware Clinical Research Unit (DCRU)

    Minneapolis, Minnesota, 55414, United States

  • Nemocnice AGEL Ostrava - Vitkovice a.s.

    Ostrava, Ostrava Město, 703 84, Czechia

  • Nemocnice Jihlava

    Jihlava, 58633, Czechia

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808, United States

  • PriMED Clinical Research

    Dayton, Ohio, 45429, United States

  • Rambam Health Care Campus

    Haifa, Northern District, 3109601, Israel

  • ReFit Clinic

    Olomouc, Olomouc Region, 779 00, Czechia

  • Samodzielny Publiczny Szpital Kliniczny nr 1 SUM

    Zabrze, Silesian Voivodeship, 41-800, Poland

  • Schneider Children's Medical Center

    Petah Tikva, Central District, 4920235, Israel

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 9013102, Israel

  • Sheba Medical Center

    Ramat Gan, Central District, 5262100, Israel

  • Solaris Clinical Research

    Meridian, Idaho, 83646, United States

  • Soroka Medical Center

    Beersheba, Southern District, 8410101, Israel

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • The Wharton Medical Clinic Clinical Trials Inc

    Hamilton, Ontario, L8L 5G8, Canada

  • Vanderbilt Health One Hundred Oaks

    Nashville, Tennessee, 372212, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Yitzhak Shamir Medical Center

    Beer Yaacov, Central District, 70300, Israel

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Other studies related to the condition(s) this trial covers.