RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07817875

Registry updated: 2026-10-13

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Description

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.

Interventions

Tirzepatide (Drug)
Administered SC
Placebo (Drug)
Administered SC

Eligibility criteria

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.

Conditions

Obesity

Locations

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
Florida Hospital- Center for Pediatric Research — Orlando, Florida, United States
Nemours Children's Health — Orlando, Florida, United States
All Childrens Hospital — St. Petersburg, 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
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 — 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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