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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)
Sponsor: Eli Lilly and Company
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.
Official title: Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial
Key Details
Gender
All
Age Range
6 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-09
Completion Date
2032-12
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
Tirzepatide
Administered SC
Placebo
Administered SC
Locations (84)
University of Arizona
Tucson, Arizona, United States
Loma Linda University School of Medicine
Loma Linda, California, United States
Childrens Hospital of Los Angeles
Los Angeles, California, United States
UCLA Mattel Children's Hospital
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Oxnard, California, United States
Children's Hospital Colorado
Colorado Springs, Colorado, United States
Yale New Haven Children's Hospital
New Haven, Connecticut, United States
William A. Shands Hospital at the University of Florida
Gainesville, Florida, United States
Florida Hospital- Center for Pediatric Research
Orlando, Florida, United States
Nemours Children's Health
Orlando, Florida, United States
All Childrens Hospital
Saint Petersburgh, Florida, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, United States
Ann and Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Norton Children's Endocrinology
Louisville, Kentucky, United States
Johns Hopkins Children's Center
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Helen Devos Childrens' Hospital - PIN
Grand Rapids, Michigan, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States
Mayo Clinic - PIN
Rochester, Minnesota, United States
Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center
Saint Paul, Minnesota, United States
Children's Hospital & Medical Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
UBMD Pediatrics
Buffalo, New York, United States
UNC Children's Hospital
Chapel Hill, North Carolina, United States
Duke Children's Primary Care
Durham, North Carolina, United States
Lucas Research, Inc
Morehead City, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oklahoma Childrens Memorial Hospital
Oklahoma City, Oklahoma, United States
Coastal Pediatric Associates
Charleston, South Carolina, United States
Medical University of South Carolina Children Hospital - PIN
Charleston, South Carolina, United States
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, United States
Dell Children's Medical Center - PIN
Austin, Texas, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
McGovern Medical School
Houston, Texas, United States
Texas Childrens Hospital
Houston, Texas, United States
VCU Health - Center for Endocrinology Diabetes and Metabolism
Richmond, Virginia, United States
Seattle Children's Research Institute - Hughes Building - PIN
Seattle, Washington, United States
MultiCare Health System - Mary Bridge Children's Health Center
Tacoma, Washington, United States
Cliniques Universitaires Saint-Luc - PPDS
Brussels, Belgium
UZ Brussel
Jette, Belgium
UZ Leuven
Leuven, Belgium
Shamir Medical Center
Beer Jacob, Israel
Soroka Medical Center
Beersheba, Israel
Rambam Health Care Campus
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Hadassah Medical Center
Jerusalem, Israel
Schneider Children's Medical Center
Petah Tikva, Israel
Azienda Ospedaliero Universitaria Meyer
Florence, Italy
Azienda Ospedaliera Universitaria Policlinico de Modena
Modena, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
Ospedale Pediatrico Bambino Gesù
Roma, Italy
PanAmerican Clinical Research - Guadalajara
Guadalajara, Mexico
Centro de Investigacion Farmacologica Del Bajio Sc
León, Mexico
Christus - Latam Hub Center of Excellence and Innovation S.C.
Monterrey, Mexico
Panamerican Clinical Research Mexico
Querétaro, Mexico
UMED Clinical Trials
Lodz, Poland
Kliniczny Szpital Wojewódzki Nr 2 im. SW Jadwigi Królowej w Rzeszowie
Rzeszów, Poland
ELIPSA - Elżbieta Lipska praktyka lekarska Ośrodek Endokrynologii i Diabetologii Dziecięcej
Stanisławów Pierwszy, Poland
ETG Justmed - PPDS
Warsaw, Poland
Futuremeds Targowek
Warsaw, Poland
Instytut Diabetologii - Warsaw
Warszewo, Poland
Premium Clinic Wrocław Centrum Medyczne
Wroclaw, Poland
Przychodnia FutureMeds Wrocław
Wroclaw, Poland
Hospital da Luz Lisboa
Lisbon, Portugal
Centro Materno Infantil do Norte
Porto, Portugal
Hospital CUF Porto
Porto, Portugal
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Asan Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Spain
Hospital Regional Universitario de Malaga - Hospital Materno-Infantil
Málaga, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Spain
Instituto Hispalense de Pediatria
Seville, Spain
Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
Vitoria-Gasteiz, Spain
National Cheng-Kung Uni. Hosp.
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan City, Taiwan