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Can a weekly shot help young children with obesity? a phase 3 trial puts tirzepatide to the test

NCT ID NCT07817875

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether tirzepatide, given as a weekly injection, can help children aged 6 to under 12 who have obesity. All participants also receive support for healthy eating and exercise. The trial compares tirzepatide with a placebo and measures changes in body mass index, weight, waist size, blood pressure, and other health markers over about two years.

What this could mean

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

Active substance
tirzepatide, a once-weekly injected drug
What this could lead to
If it works, this could give doctors a medication option for young children with obesity, a group that has few drug treatments approved for their age.
What could go wrong
The trial is testing a drug in young children, so safety and side effects are closely watched. Results in this age group may differ from adults, and the drug may not help enough to justify its use.

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

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2032

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

6 to 11 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: J4M-MC-PW02 * Are 6 to less than 12 years of age (Tanner stage 1 to 5 inclusive) * Have: * a body weight of ≥ 40 kilograms (kg) (88 pounds), and * been diagnosed with obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart J4M-MC-PWMP * Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening. * Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \[CDC-NCHS, 2022\]) Exclusion Criteria: J4M-MC-PW02 * Have a history of * proliferative diabetic retinopathy * diabetic macular edema, or * nonproliferative diabetic retinopathy that requires acute treatment J4M-MC-PWMP * 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. * Have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes. * Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state. * Have HbA1c \>9.0% (75 mmol/mol) as measured by central laboratory at screening. * Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder

As listed by the trial registrant

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

Obesity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    84 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • All Childrens Hospital

    Saint Petersburgh, Florida, 33701, United States

  • Ann and Robert H Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Azienda Ospedaliera Universitaria Policlinico de Modena

    Modena, 41124, Italy

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100, Italy

  • Azienda Ospedaliero Universitaria Meyer

    Florence, 50139, Italy

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43126, Italy

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Carey Chronis MD Pediatric, Infant and Adolescent Medicine

    Oxnard, California, 93003-5314, United States

  • Centro Materno Infantil do Norte

    Porto, 4050-651, Portugal

  • Centro de Investigacion Farmacologica Del Bajio Sc

    León, 37160, Mexico

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan City, 33305, Taiwan

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics

    Atlanta, Georgia, 30329, United States

  • Children's Hospital & Medical Center

    Omaha, Nebraska, 68114, United States

  • Children's Hospital Colorado

    Colorado Springs, Colorado, 80920-7843, United States

  • Children's Hospital of Orange County

    Orange, California, 92868, United States

  • Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center

    Saint Paul, Minnesota, 55102-3354, United States

  • Childrens Hospital of Los Angeles

    Los Angeles, California, 90027, United States

  • Christus - Latam Hub Center of Excellence and Innovation S.C.

    Monterrey, 64060, Mexico

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cliniques Universitaires Saint-Luc - PPDS

    Brussels, 1200, Belgium

  • Coastal Pediatric Associates

    Charleston, South Carolina, 29414, United States

  • Corporacio Sanitaria Parc Tauli

    Sabadell, 8208, Spain

  • Dell Children's Medical Center - PIN

    Austin, Texas, 78723-3079, United States

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411, United States

  • Duke Children's Primary Care

    Durham, North Carolina, 27704-2102, United States

  • ELIPSA - Elżbieta Lipska praktyka lekarska Ośrodek Endokrynologii i Diabetologii Dziecięcej

    Stanisławów Pierwszy, 05-126, Poland

  • ETG Justmed - PPDS

    Warsaw, 02 - 696, Poland

  • Florida Hospital- Center for Pediatric Research

    Orlando, Florida, 32803, United States

  • Futuremeds Targowek

    Warsaw, 03-291, Poland

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Helen Devos Childrens' Hospital - PIN

    Grand Rapids, Michigan, 49503-2560, United States

  • Hospital CUF Porto

    Porto, 4100-180, Portugal

  • Hospital Infantil Universitario Niño Jesús

    Madrid, 28009, Spain

  • Hospital Regional Universitario de Malaga - Hospital Materno-Infantil

    Málaga, 29011, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario de Araba (HUA)- Hospital Txagorritxu

    Vitoria-Gasteiz, 01009, Spain

  • Hospital da Luz Lisboa

    Lisbon, 1500-650, Portugal

  • Instituto Hispalense de Pediatria

    Seville, 41014, Spain

  • Instytut Diabetologii - Warsaw

    Warszewo, 2117, Poland

  • Johns Hopkins Children's Center

    Baltimore, Maryland, 21287, United States

  • Kliniczny Szpital Wojewódzki Nr 2 im. SW Jadwigi Królowej w Rzeszowie

    Rzeszów, 35-301, Poland

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Loma Linda University School of Medicine

    Loma Linda, California, 92354, United States

  • Lucas Research, Inc

    Morehead City, North Carolina, 28557, United States

  • Mayo Clinic - PIN

    Rochester, Minnesota, 55905-0001, United States

  • McGovern Medical School

    Houston, Texas, 77030-1521, United States

  • Medical University of South Carolina Children Hospital - PIN

    Charleston, South Carolina, 29425, United States

  • MultiCare Health System - Mary Bridge Children's Health Center

    Tacoma, Washington, 98405, United States

  • National Cheng-Kung Uni. Hosp.

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Nemours Children's Health

    Orlando, Florida, 32827, United States

  • Norton Children's Endocrinology

    Louisville, Kentucky, 40202, United States

  • Oklahoma Childrens Memorial Hospital

    Oklahoma City, Oklahoma, 73104-5008, United States

  • Ospedale Pediatrico Bambino Gesù

    Roma, 165, Italy

  • PanAmerican Clinical Research - Guadalajara

    Guadalajara, 44670, Mexico

  • Panamerican Clinical Research Mexico

    Querétaro, 76230, Mexico

  • Premium Clinic Wrocław Centrum Medyczne

    Wroclaw, 50-414, Poland

  • Przychodnia FutureMeds Wrocław

    Wroclaw, 53-673, Poland

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • Schneider Children's Medical Center

    Petah Tikva, 4920235, Israel

  • Seattle Children's Research Institute - Hughes Building - PIN

    Seattle, Washington, 98101, United States

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Shamir Medical Center

    Beer Jacob, 73100, Israel

  • Soroka Medical Center

    Beersheba, 8410101, Israel

  • Texas Childrens Hospital

    Houston, Texas, 77030, United States

  • UBMD Pediatrics

    Buffalo, New York, 14203, United States

  • UCLA Mattel Children's Hospital

    Los Angeles, California, 90095, United States

  • UMED Clinical Trials

    Lodz, 92-213, Poland

  • UNC Children's Hospital

    Chapel Hill, North Carolina, 27514, United States

  • UZ Brussel

    Jette, 1090, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • University of Arizona

    Tucson, Arizona, 85721, United States

  • University of Illinois at Chicago

    Chicago, Illinois, 60612, United States

  • University of Minnesota Masonic Children's Hospital

    Minneapolis, Minnesota, 55454, United States

  • VCU Health - Center for Endocrinology Diabetes and Metabolism

    Richmond, Virginia, 23229-3156, United States

  • Vanderbilt Health One Hundred Oaks

    Nashville, Tennessee, 37204-3609, United States

  • William A. Shands Hospital at the University of Florida

    Gainesville, Florida, 32610-3003, United States

  • Yale New Haven Children's Hospital

    New Haven, Connecticut, 06504, United States

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