New pill could help kids fight obesity – clinical trial underway

NCT ID NCT06672549

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

First seen Jun 24, 2026 · Last updated Aug 25, 2026 · Updated 5 times

Summary

This Phase 3 trial is testing an oral medication called orforglipron for chronic weight management in children and teens with obesity or overweight. The study will enroll 125 participants who have already tried lifestyle changes without success. The goal is to see if the drug is safe and effective for helping young people manage their weight.

What this could mean

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

Active substance: orforglipron (an oral medication)
What this could lead to: If successful, this could provide a new oral medication option for managing weight in children and teens with obesity or overweight.
What could go wrong: This is an early-stage platform trial with a small number of participants, so results may not apply broadly. The drug may cause side effects or fail to show meaningful weight loss.

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 125 people

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

Started

Nov 2024

Expected to finish

Mar 2027

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 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 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 \[CDC-NCHS, 2022\]); OR * Applies to participant age between 12 and \<18 years old. 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 (CDC-NCHS, 2022), and at least 1 weight-related comorbidity, * hypertension * type 2 diabetes (T2D) * prediabetes * dyslipidemia * obstructive sleep apnea * metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD) Exclusion Criteria: * 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 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 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 Overweight

As listed by the trial registrant

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

Obesity Overweight

How to take part

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

The places running it

117 sites in 13 countries. The list below names each one and where it is.
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 ↗
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

Addenbrookes Hospital
NOT_YET_RECRUITING

Cambridge, CB2 0QQ, United Kingdom
Alder Hey Children's Hospital
NOT_YET_RECRUITING

Liverpool, L14 5AB, United Kingdom
All Childrens Hospital
NOT_YET_RECRUITING

St. Petersburg, Florida, 33701, United States
Ann and Robert Lurie Children's Hospital of Chicago
NOT_YET_RECRUITING

Chicago, Illinois, 60611, United States
Asan Medical Center
NOT_YET_RECRUITING

Seoul, 5505, South Korea
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
NOT_YET_RECRUITING

Verona, 37126, Italy
Azienda Ospedaliera Universitaria Policlinico de Modena
NOT_YET_RECRUITING

Modena, 41124, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
NOT_YET_RECRUITING

Novara, 28100, Italy
Azienda Ospedaliero Universitaria Meyer
NOT_YET_RECRUITING

Florence, 50139, Italy
Azienda Ospedaliero Universitaria di Parma
NOT_YET_RECRUITING

Parma, 43126, Italy
Barnsley Hospital NHS Foundation Trust
NOT_YET_RECRUITING

Barnsley, S75 2EP, United Kingdom
Boston Children's Hospital
NOT_YET_RECRUITING

Boston, Massachusetts, 02115, United States
Bristol Royal Hospital for Children
NOT_YET_RECRUITING

Bristol, BS2 8BJ, United Kingdom
CPQuali Pesquisa Clínica Sao Paulo
NOT_YET_RECRUITING

São Paulo, 01228-000, Brazil
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
NOT_YET_RECRUITING

Oxnard, California, 93030, United States
Centro Materno Infantil do Norte
NOT_YET_RECRUITING

Porto, 4050-651, Portugal
Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC
NOT_YET_RECRUITING

Culiacán, 80000, Mexico
Centro de Investigacion Farmacologica Del Bajio Sc
NOT_YET_RECRUITING

León, 37160, Mexico
Chaim Sheba Medical Center
NOT_YET_RECRUITING

Ramat Gan, 5262100, Israel
Chang Gung Medical Foundation-Linkou Branch
NOT_YET_RECRUITING

Taoyuan, 33305, China
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
NOT_YET_RECRUITING

Atlanta, Georgia, 30329, United States
Children's Hospital Colorado
NOT_YET_RECRUITING

Colorado Springs, Colorado, 80920-7843, United States
Children's Hospital of Orange County - Orange
NOT_YET_RECRUITING

Orange, California, 92868, United States
Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center
NOT_YET_RECRUITING

Saint Paul, Minnesota, 55102-3354, United States
Childrens Hospital of Los Angeles
NOT_YET_RECRUITING

Los Angeles, California, 90027, United States
Cleveland Clinic
NOT_YET_RECRUITING

Cleveland, Ohio, 44195, United States
Cliniques Universitaires Saint-Luc - PPDS
NOT_YET_RECRUITING

Brussels, 1200, Belgium
Coastal Pediatric Associates
NOT_YET_RECRUITING

Charleston, South Carolina, 29414, United States
Corporacio Sanitaria Parc Tauli
NOT_YET_RECRUITING

Sabadell, 8208, Spain
Dell Children's Medical Center - PIN
NOT_YET_RECRUITING

Austin, Texas, 78723-3079, United States
Driscoll Children's Hospital
NOT_YET_RECRUITING

Corpus Christi, Texas, 78411, United States
Duke Children's Primary Care
NOT_YET_RECRUITING

Durham, North Carolina, 27704-2102, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
NOT_YET_RECRUITING

Gulfport, Mississippi, 39503-2637, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
NOT_YET_RECRUITING

Houston, Texas, 77065, United States
ELIPSA - Elżbieta Lipska praktyka lekarska Ośrodek Endokrynologii i Diabetologii Dziecięcej
NOT_YET_RECRUITING

Stanisławów Pierwszy, 05-126, Poland
ETG Justmed - PPDS
NOT_YET_RECRUITING

Warsaw, 02 - 696, Poland
Florida Hospital- Center for Pediatric Research
NOT_YET_RECRUITING

Orlando, Florida, 32803, United States
FutureMeds - Targowek
NOT_YET_RECRUITING

Warsaw, 03-291, Poland
FutureMeds sp. z o. o.
NOT_YET_RECRUITING

Wroclaw, 53-673, Poland
Hackensack University Medical Center
NOT_YET_RECRUITING

Hackensack, New Jersey, 07601, United States
Hadassah Medical Center
NOT_YET_RECRUITING

Jerusalem, 9112001, Israel
Hanyang University Seoul Hospital
NOT_YET_RECRUITING

Seoul, 04763, South Korea
Helen Devos Childrens' Hospital - PIN
NOT_YET_RECRUITING

Grand Rapids, Michigan, 49503-2560, United States
Hospital Angeles Puebla
NOT_YET_RECRUITING

Puebla City, 72190, Mexico
Hospital CUF Porto
NOT_YET_RECRUITING

Porto, 4100-180, Portugal
Hospital Infantil Universitario Niño Jesús
NOT_YET_RECRUITING

Madrid, 28009, Spain
Hospital Regional Universitario de Malaga - Hospital Materno-Infantil
NOT_YET_RECRUITING

Málaga, 29011, Spain
Hospital Universitario Vall d'Hebron
NOT_YET_RECRUITING

Barcelona, 08035, Spain
Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
NOT_YET_RECRUITING

Vitoria-Gasteiz, 01009, Spain
Hospital Universitario de Caxias do Sul
NOT_YET_RECRUITING

Caxias do Sul, 95070-560, Brazil
Hospital da Luz Lisboa
NOT_YET_RECRUITING

Lisbon, 1500-650, Portugal
Hull Royal Infirmary - MAIN
NOT_YET_RECRUITING

Hull, HU3 2JZ, United Kingdom
Innovacion y Desarrollo de Estrategias en Salud SA de CV
NOT_YET_RECRUITING

Mexico City, 14090, Mexico
Instituto Hispalense de Pediatria
NOT_YET_RECRUITING

Seville, 41014, Spain
Instytut Diabetologii
NOT_YET_RECRUITING

Warsaw, 02-117, Poland
Isesaki Municipal Hospital
NOT_YET_RECRUITING

Isesaki-shi, 372-0817, Japan
Johns Hopkins Children's Center
NOT_YET_RECRUITING

Baltimore, Maryland, 21287, United States
Kliniczny Szpital Wojewódzki Nr 2 im. SW Jadwigi Królowej w Rzeszowie
NOT_YET_RECRUITING

Rzeszów, 35-301, Poland
Korea University Guro Hospital
NOT_YET_RECRUITING

Seoul, 08308, South Korea
Krakowskie Centrum Medyczne
NOT_YET_RECRUITING

Krakow, 31-501, Poland
L2IP - Instituto de Pesquisas Clínicas
NOT_YET_RECRUITING

Brasília, 70200730, Brazil
La Providence Pediatrics Clinic - Chemidox Clinical Trials
NOT_YET_RECRUITING

Houston, Texas, 77071-1008, United States
Loma Linda University School of Medicine
NOT_YET_RECRUITING

Loma Linda, California, 92354, United States
Lucas Research, Inc
RECRUITING

Morehead City, North Carolina, 28557, United States
Martin Diagnostic Clinic
NOT_YET_RECRUITING

Tomball, Texas, 77375-3332, United States
Mayo Clinic - PIN
NOT_YET_RECRUITING

Rochester, Minnesota, 55905-0001, United States
McGovern Medical School
NOT_YET_RECRUITING

Houston, Texas, 77030-1521, United States
Medical University of South Carolina Children Hospital - PIN
NOT_YET_RECRUITING

Charleston, South Carolina, 29425, United States
MultiCare Health System - Mary Bridge Children's Health Center
NOT_YET_RECRUITING

Tacoma, Washington, 98405, United States
Nara Prefecture General Medical Center
NOT_YET_RECRUITING

Nara, 630-8054, Japan
National Cheng Kung University Hospital
NOT_YET_RECRUITING

Tainan, 704, China
National Taiwan University Hospital
NOT_YET_RECRUITING

Taipei, 10002, China
Nationwide Children's Hospital
NOT_YET_RECRUITING

Columbus, Ohio, 43205, United States
Nemours Children's Health
NOT_YET_RECRUITING

Orlando, Florida, 32827, United States
Ninewells Hospital
NOT_YET_RECRUITING

Dundee, DD1 9SY, United Kingdom
Northwick Park Hospital
NOT_YET_RECRUITING

Harrow, HA1 3UJ, United Kingdom
Norton Children's Endocrinology
NOT_YET_RECRUITING

Louisville, Kentucky, 40202, United States
Omaha Childrens Hospital
NOT_YET_RECRUITING

Omaha, Nebraska, 68114, United States
Osaka City General Hospital
NOT_YET_RECRUITING

Osaka, 534-0021, Japan
Ospedale Pediatrico Bambino Gesù
NOT_YET_RECRUITING

Roma, 165, Italy
Ospedale Pediatrico Bambino Gesù
NOT_YET_RECRUITING

Roma, 165, Italy
PanAmerican Clinical Research - Av. Antea 1032 - PPDS
NOT_YET_RECRUITING

Juriquilla, 76230, Mexico
PanAmerican Clinical Research - Guadalajara
NOT_YET_RECRUITING

Guadalajara, 44670, Mexico
Premium Clinic Wrocław Centrum Medyczne
NOT_YET_RECRUITING

Wroclaw, 50-414, Poland
Rambam Health Care Campus
NOT_YET_RECRUITING

Haifa, 3109601, Israel
Riley Hospital for Children
NOT_YET_RECRUITING

Indianapolis, Indiana, 46202, United States
Sagaekiminami Clinic
NOT_YET_RECRUITING

Saga, 840-0801, Japan
Saitama Medical University Hospital
NOT_YET_RECRUITING

Iruma-Gun, 350-0495, Japan
Schneider Children's Medical Center
NOT_YET_RECRUITING

Petah Tikva, 4920235, Israel
Seattle Children's Research Institute - Hughes Building - PIN
NOT_YET_RECRUITING

Seattle, Washington, 98101, United States
Seoul National University Bundang Hospital
NOT_YET_RECRUITING

Seongnam-si, 13620, South Korea
Shaare Zedek Medical Center
NOT_YET_RECRUITING

Jerusalem, 9013102, Israel
Shiga General Hospital
NOT_YET_RECRUITING

Moriyama, 524-8524, Japan
Shikoku Medical Center for Children and Adults
NOT_YET_RECRUITING

Zentsujichó, 765-8507, Japan
Stamford Therapeutics Consortium
NOT_YET_RECRUITING

Stamford, Connecticut, 06905, United States
Sundance Clinical Research
NOT_YET_RECRUITING

St Louis, Missouri, 63141-7068, United States
Tokyo Medical Center
NOT_YET_RECRUITING

Meguro-Ku, 152-0021, Japan
UBMD Pediatrics
NOT_YET_RECRUITING

Buffalo, New York, 14203, United States
UCLA Mattel Children's Hospital
NOT_YET_RECRUITING

Los Angeles, California, 90095, United States
UMED Clinical Trials
NOT_YET_RECRUITING

Lodz, 92-213, Poland
UNC Children's Hospital
NOT_YET_RECRUITING

Chapel Hill, North Carolina, 27514, United States
UPMC Children's Hospital of Pittsburgh
NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15224, United States
UZ Brussel
NOT_YET_RECRUITING

Brussels, 1090, Belgium
UZ Leuven
NOT_YET_RECRUITING

Leuven, 3000, Belgium
University Hospital,Kyoto Prefectural University of Medicine
NOT_YET_RECRUITING

Kyoto, 602-8566, Japan
University of Arizona
NOT_YET_RECRUITING

Tucson, Arizona, 85721, United States
University of Illinois at Chicago
NOT_YET_RECRUITING

Chicago, Illinois, 60612, United States
University of Minnesota Masonic Children's Hospital
NOT_YET_RECRUITING

Minneapolis, Minnesota, 55454, United States
University of Oklahoma Health Sciences Center
NOT_YET_RECRUITING

Oklahoma City, Oklahoma, 73104, United States
VCU Health - Center for Endocrinology Diabetes and Metabolism
NOT_YET_RECRUITING

Richmond, Virginia, 23229-3156, United States
Vanderbilt Health One Hundred Oaks
NOT_YET_RECRUITING

Nashville, Tennessee, 37204, United States
Velocity Clinical Research
NOT_YET_RECRUITING

Lafayette, Louisiana, 70508, United States
Velocity Clinical Research
NOT_YET_RECRUITING

Omaha, Nebraska, 68134, United States
Velocity Clinical Research, Salt Lake City
NOT_YET_RECRUITING

West Jordan, Utah, 84088, United States
William A. Shands Hospital at the University of Florida
NOT_YET_RECRUITING

Gainesville, Florida, 32610-3003, United States
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
NOT_YET_RECRUITING

New Haven, Connecticut, 06519, United States
Yitzhak Shamir Medical Center
NOT_YET_RECRUITING

Beer Yaacov, 70300, Israel

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