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NCT07817875PHASE3Recruiting

Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)

Eli Lilly and Company

Start Date

9/25/2026

Completion Date

12/1/2032

Summary

The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of tirzepatide as an addition to healthy lifestyle in participants 6 to less than 12 years of age, with obesity. Participation in the study will last about 104 weeks. Participants who have completed the primary 104-week PW02 study (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

Eligibility Criteria

Age Range: 6 years to 11 years

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.

Interventions

DRUG

Tirzepatide

DRUG

Placebo

Interested in This Trial?

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Conditions

Obesity

Locations

University of Arizona

Tucson, Arizona 85721

United States

Loma Linda University School of Medicine

Loma Linda, California 92354

United States

Childrens Hospital of Los Angeles

Los Angeles, California 90027

United States

UCLA Mattel Children's Hospital

Los Angeles, California 90095

United States

Children's Hospital of Orange County

Orange, California 92868

United States

Carey Chronis MD Pediatric, Infant and Adolescent Medicine

Oxnard, California 93003-5314

United States

Children's Hospital Colorado

Colorado Springs, Colorado 80920-7843

United States

Yale New Haven Children's Hospital

New Haven, Connecticut 06504

United States

Florida Hospital- Center for Pediatric Research

Orlando, Florida 32803

United States

Nemours Children's Health

Orlando, Florida 32827

United States

All Childrens Hospital

St. Petersburg, Florida 33701

United States

Children's Healthcare of Atlanta - Center for Advanced Pediatrics

Atlanta, Georgia 30329

United States

Ann and Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois 60611

United States

University of Illinois at Chicago

Chicago, Illinois 60612

United States

Riley Hospital for Children

Indianapolis, Indiana 46202

United States

Norton Children's Endocrinology

Louisville, Kentucky 40202

United States

Johns Hopkins Children's Center

Baltimore, Maryland 21287

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

Helen Devos Childrens' Hospital - PIN

Grand Rapids, Michigan 49503-2560

United States

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota 55454

United States

Mayo Clinic - PIN

Rochester, Minnesota 55905-0001

United States

Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center

Saint Paul, Minnesota 55102-3354

United States

Children's Hospital & Medical Center

Omaha, Nebraska 68114

United States

UBMD Pediatrics

Buffalo, New York 14203

United States

UNC Children's Hospital

Chapel Hill, North Carolina 27514

United States

Duke Children's Primary Care

Durham, North Carolina 27704-2102

United States

Lucas Research, Inc

Morehead City, North Carolina 28557

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Oklahoma Childrens Memorial Hospital

Oklahoma City, Oklahoma 73104-5008

United States

Coastal Pediatric Associates

Charleston, South Carolina 29414

United States

Medical University of South Carolina Children Hospital

Charleston, South Carolina 29425

United States

Vanderbilt Health One Hundred Oaks

Nashville, Tennessee 37204-3609

United States

Dell Children's Medical Center - PIN

Austin, Texas 78723-3079

United States

Driscoll Children's Hospital

Corpus Christi, Texas 78411

United States

McGovern Medical School

Houston, Texas 77030-1521

United States

Texas Childrens Hospital

Houston, Texas 77030

United States

VCU Health - Center for Endocrinology Diabetes and Metabolism

Richmond, Virginia 23229-3156

United States

Seattle Children's Research Institute - Hughes Building - PIN

Seattle, Washington 98101

United States

MultiCare Health System - Mary Bridge Children's Health Center

Tacoma, Washington 98405

United States

Cliniques Universitaires Saint-Luc - PPDS

Brussels, 1200

Belgium

UZ Brussel

Jette, 1090

Belgium

UZ Leuven

Leuven, 3000

Belgium

Shamir Medical Center

Beer Jacob, 73100

Israel

Soroka Medical Center

Beersheba, 8410101

Israel

Rambam Health Care Campus

Haifa, 3109601

Israel

Shaare Zedek Medical Center

Jerusalem, 9103102

Israel

Hadassah Medical Center

Jerusalem, 9112001

Israel

Schneider Children's Medical Center

Petah Tikva, 4920235

Israel

Azienda Ospedaliero Universitaria Meyer

Florence, 50139

Italy

Azienda Ospedaliera Universitaria Policlinico de Modena

Modena, 41124

Italy

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, 28100

Italy

Azienda Ospedaliero Universitaria di Parma

Parma, 43126

Italy

Ospedale Pediatrico Bambino Gesù

Roma, 165

Italy

PanAmerican Clinical Research - Guadalajara

Guadalajara, 44670

Mexico

Centro de Investigacion Farmacologica Del Bajio Sc

León, 37160

Mexico

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

Monterrey, 64060

Mexico

Panamerican Clinical Research Mexico

Querétaro, 76230

Mexico

UMED Clinical Trials

Lodz, 92-213

Poland

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

Rzeszów, 35-301

Poland

ELIPSA - Elżbieta Lipska praktyka lekarska Ośrodek Endokrynologii i Diabetologii Dziecięcej

Stanisławów Pierwszy, 05-126

Poland

ETG Justmed - PPDS

Warsaw, 02 - 696

Poland

Futuremeds Targowek

Warsaw, 03-291

Poland

Instytut Diabetologii - Warsaw

Warszewo, 2117

Poland

Premium Clinic Wrocław Centrum Medyczne

Wroclaw, 50-414

Poland

Przychodnia FutureMeds Wrocław

Wroclaw, 53-673

Poland

Hospital da Luz Lisboa

Lisbon, 1500-650

Portugal

Centro Materno Infantil do Norte

Porto, 4050-651

Portugal

Hospital CUF Porto

Porto, 4100-180

Portugal

Seoul National University Bundang Hospital

Seongnam-si, 13620

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Korea University Guro Hospital

Seoul, 08308

South Korea

Hospital Universitario Vall d'Hebron

Barcelona, 08035

Spain

Hospital Infantil Universitario Niño Jesús

Madrid, 28009

Spain

Hospital Regional Universitario de Malaga - Hospital Materno-Infantil

Málaga, 29011

Spain

Corporacio Sanitaria Parc Tauli

Sabadell, 8208

Spain

Instituto Hispalense de Pediatria

Seville, 41014

Spain

Hospital Universitario de Araba (HUA)- Hospital Txagorritxu

Vitoria-Gasteiz, 01009

Spain

National Cheng-Kung Uni. Hosp.

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Chang Gung Memorial Hospital - Linkou

Taoyuan City, 33305

Taiwan