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New weekly shot could help teens with obesity and related health problems

NCT ID NCT06439277

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 04, 2026 · Updated 7 times

Summary

This study tests whether a weekly injection of tirzepatide, combined with healthy eating and exercise, helps adolescents with obesity and related conditions like high blood pressure or prediabetes lose weight and improve their health. About 300 teens who completed a prior study can join this 156-week extension. The goal is to see if the drug leads to meaningful weight loss and better control of weight-related health issues.

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 injection)
What this could lead to
If successful, this could provide a long-term treatment option for adolescents with obesity and related health issues like high blood pressure or prediabetes.
What could go wrong
This is an extension study, so results are still preliminary. The drug may cause side effects like nausea or vomiting, and not all participants may see significant benefits.

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 300 people

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

Started

Jun 2024

Expected to finish

Dec 2030

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 body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia. * Have history of at least 1 self-reported unsuccessful dietary effort to lose weight. * Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable). Exclusion Criteria: * Have undergone or plan to undergo a 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 self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state * Have type 2 diabetes or have a HbA1c \> 6.4% at screening * Have a history of chronic or acute pancreatitis * 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 Weight Gain

As listed by the trial registrant

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

Obesity Weight gain

How to take part

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

  1. The places running it

    2 sites. 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

  • Addenbrooke's Hospital

    ACTIVE_NOT_RECRUITING

    Cambridge, CB2 0SL, United Kingdom

  • Alder Hey Children's Hospital

    COMPLETED

    Liverpool, L14 5AB, United Kingdom

  • Alliance for Multispecialty Research, LLC

    COMPLETED

    Layton, Utah, 84041, United States

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60611, United States

  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T

    ACTIVE_NOT_RECRUITING

    Paris, 75019, France

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    ACTIVE_NOT_RECRUITING

    Marseille, 13385, France

  • Bluewater Clinical Research Group Inc.

    COMPLETED

    Sarnia, N7T 4X3, Canada

  • CHU de Toulouse - Hôpital des Enfants

    COMPLETED

    Toulouse, 31059, France

  • Carmel Hospital

    ACTIVE_NOT_RECRUITING

    Haifa, 3436212, Israel

  • Centre Hospitalier Universitaire d'Angers

    ACTIVE_NOT_RECRUITING

    Angers, 49933, France

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    ACTIVE_NOT_RECRUITING

    Buenos Aires, C1425AGC, Argentina

  • Centro de Atención e Investigación Clínica

    ACTIVE_NOT_RECRUITING

    Aguascalientes, 20129, Mexico

  • Centro de Investigacion Medica de Occidente, S.C.

    ACTIVE_NOT_RECRUITING

    Guadalajara, 44260, Mexico

  • Centro de Investigaciones Metabólicas (CINME)

    ACTIVE_NOT_RECRUITING

    Buenos Aires, C1056ABI, Argentina

  • Centro de Investigaciones Médicas Tucuman

    ACTIVE_NOT_RECRUITING

    SAN M. de Tucuman, T4000AXL, Argentina

  • Chang Gung Medical Foundation-Linkou Branch

    ACTIVE_NOT_RECRUITING

    Taoyuan, 333, Taiwan

  • Children's Hospital Los Angeles

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90027, United States

  • China Medical University Hospital

    ACTIVE_NOT_RECRUITING

    Taichung, 404332, Taiwan

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

    ACTIVE_NOT_RECRUITING

    Monterrey, 64060, Mexico

  • Clínica García Flores SC

    ACTIVE_NOT_RECRUITING

    Monterrey, 64610, Mexico

  • Consano Clinical Research, LLC

    ACTIVE_NOT_RECRUITING

    Shavano Park, Texas, 78231, United States

  • Consultorio Médico de Endocrinología y Pediatría

    ACTIVE_NOT_RECRUITING

    Puebla City, 72190, Mexico

  • Cornerstone Dermatology

    ACTIVE_NOT_RECRUITING

    Coorparoo, 4151, Australia

  • DIM Clínica Privada

    ACTIVE_NOT_RECRUITING

    Ramos Mejía, B1704ETD, Argentina

  • Driscoll Children's Hospital

    ACTIVE_NOT_RECRUITING

    Corpus Christi, Texas, 78411, United States

  • Emek Medical Center

    ACTIVE_NOT_RECRUITING

    Afula, 1834111, Israel

  • Epic Medical Research - DeSoto

    ACTIVE_NOT_RECRUITING

    DeSoto, Texas, 75115, United States

  • Fundación Respirar

    COMPLETED

    Buenos Aires, C1426ABP, Argentina

  • H.R.U Málaga - Hospital General

    ACTIVE_NOT_RECRUITING

    Málaga, 29011, Spain

  • Hospices Civils de Lyon - Hopital Louis Pradel

    ACTIVE_NOT_RECRUITING

    Bron, 69677, France

  • Hospital Infantil Universitario Niño Jesús

    ACTIVE_NOT_RECRUITING

    Madrid, 28009, Spain

  • Hospital Universitari Vall d'Hebron

    ACTIVE_NOT_RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    ACTIVE_NOT_RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Reina Sofia

    ACTIVE_NOT_RECRUITING

    Córdoba, 14004, Spain

  • Hôpital Armand Trousseau

    ACTIVE_NOT_RECRUITING

    Paris, 75012, France

  • Hôpital Jeanne de Flandre

    ACTIVE_NOT_RECRUITING

    Lille, 59000, France

  • Indiana University Health University Hospital

    ACTIVE_NOT_RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Investigaciones Medicas Imoba Srl

    ACTIVE_NOT_RECRUITING

    Buenos Aires, C1056ABH, Argentina

  • Leeds General Infirmary

    ACTIVE_NOT_RECRUITING

    Leeds, LS1 3EX, United Kingdom

  • Leicester Royal Infirmary

    COMPLETED

    Leicester, LE1 5WW, United Kingdom

  • Medical Research Partners

    ACTIVE_NOT_RECRUITING

    Ammon, Idaho, 83406, United States

  • Meir Medical Center

    ACTIVE_NOT_RECRUITING

    Kfar Saba, 4428164, Israel

  • National Cheng Kung University Hospital

    ACTIVE_NOT_RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    COMPLETED

    Taipei, 10002, Taiwan

  • Nemours Children's Health - Delaware

    ACTIVE_NOT_RECRUITING

    Wilmington, Delaware, 19803, United States

  • Nightingale Research

    COMPLETED

    Adelaide, 5000, Australia

  • Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital

    COMPLETED

    London, WC1E 6DB, United Kingdom

  • Perth Children's Hospital

    COMPLETED

    Perth, 6009, Australia

  • Premier Clinical Trial Network

    NOT_YET_RECRUITING

    Hamilton, L8L5G4, Canada

  • Rambam Health Care Campus

    ACTIVE_NOT_RECRUITING

    Haifa, 3109601, Israel

  • Royal Hospital for Children

    ACTIVE_NOT_RECRUITING

    Glagow, G51 4TF, United Kingdom

  • Royal Victoria Infirmary

    ACTIVE_NOT_RECRUITING

    Newcastle upon Tyne, NE1 4PL, United Kingdom

  • SUNY Upstate Medical University

    ACTIVE_NOT_RECRUITING

    Syracuse, New York, 13210, United States

  • Schneider Children's Medical Center

    ACTIVE_NOT_RECRUITING

    Petah Tikva, 4920235, Israel

  • Shaare Zedek Medical Center

    COMPLETED

    Jerusalem, 9013102, Israel

  • Sheba Medical Center

    ACTIVE_NOT_RECRUITING

    Ramat Gan, 5262100, Israel

  • Sheffield Children's Hospital

    ACTIVE_NOT_RECRUITING

    Sheffield, S10 2TH, United Kingdom

  • Soroka Medical Center

    ACTIVE_NOT_RECRUITING

    Beersheba, 8410101, Israel

  • Southampton General Hospital

    COMPLETED

    Southampton, SO16 6YD, United Kingdom

  • Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology

    ACTIVE_NOT_RECRUITING

    Sacramento, California, 95821, United States

  • Texas Valley Clinical Research

    ACTIVE_NOT_RECRUITING

    Weslaco, Texas, 78596, United States

  • UBMD Pediatrics

    ACTIVE_NOT_RECRUITING

    Buffalo, New York, 14203, United States

  • Universitaetsklinikum Koeln

    ACTIVE_NOT_RECRUITING

    Cologne, 50937, Germany

  • Universitaetsklinikum Ulm

    ACTIVE_NOT_RECRUITING

    Ulm, 89075, Germany

  • University Pediatric Hospital

    COMPLETED

    San Juan, 00935, Puerto Rico

  • University of Sydney - Charles Perkins Centre

    ACTIVE_NOT_RECRUITING

    Sydney, 2006, Australia

  • Universitätsklinikum Leipzig

    ACTIVE_NOT_RECRUITING

    Leipzig, 04103, Germany

  • Valley Institute of Research - Fort Worth

    ACTIVE_NOT_RECRUITING

    Fort Worth, Texas, 76164, United States

  • Winterberry Research Inc.

    RECRUITING

    Hamilton, L8J 0B6, Canada

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