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)
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
Interventions
Tirzepatide
Placebo
Conditions
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