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)

September 9, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc - PPDS
        • Principal Investigator:
          • Philippe Lysy
      • Jette, Belgium, 1090
        • UZ Brussel
        • Principal Investigator:
          • Inge Gies
      • Leuven, Belgium, 3000
        • UZ Leuven
        • Principal Investigator:
          • Kristina Casteels
  • Israel
      • Beer Jacob, Israel, 73100
        • Shamir Medical Center
        • Principal Investigator:
          • Marianna Rachmiel
      • Beersheba, Israel, 8410101
        • Soroka Medical Center
        • Principal Investigator:
          • Alon Haim
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
        • Principal Investigator:
          • Ram Weiss
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
        • Principal Investigator:
          • Floris Levy-Khademi
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center
        • Principal Investigator:
          • David Zangen
        • Contact:
          • Phone Number: +972526444664
      • Petah Tikva, Israel, 4920235
        • Schneider Children's Medical Center
        • Principal Investigator:
          • Moshe Phillip
  • Italy
      • Florence, Italy, 50139
        • Azienda Ospedaliero Universitaria Meyer
        • Principal Investigator:
          • Stefano Stagi
        • Contact:
          • Phone Number: +390555662305
      • Modena, Italy, 41124
        • Azienda Ospedaliera Universitaria Policlinico de Modena
        • Principal Investigator:
          • Barbara Predieri
        • Contact:
          • Phone Number: +39 059 422 5217
      • Novara, Italy, 28100
        • Azienda Ospedaliero Universitaria Maggiore della Carita
        • Principal Investigator:
          • Ivana Rabbone
      • Parma, Italy, 43126
        • Azienda Ospedaliero Universitaria di Parma
        • Principal Investigator:
          • Maria Elisabeth Street
        • Contact:
          • Phone Number: +393206069875
      • Roma, Italy, 165
        • Ospedale Pediatrico Bambino Gesù
        • Principal Investigator:
          • Danilo Fintini
        • Contact:
          • Phone Number: +39 0668593149
  • Mexico
      • Guadalajara, Mexico, 44670
        • PanAmerican Clinical Research - Guadalajara
        • Principal Investigator:
          • Ana Lopez Beltran
        • Contact:
          • Phone Number: +52 3310079299
      • León, Mexico, 37160
        • Centro de Investigacion Farmacologica Del Bajio Sc
        • Contact:
          • Phone Number: 4773933523
        • Principal Investigator:
          • Catalina Peralta Cortázar
      • Monterrey, Mexico, 64060
        • Christus - Latam Hub Center of Excellence and Innovation S.C.
        • Contact:
          • Phone Number: 8183993400 Ext. 3652
        • Principal Investigator:
          • Hector Arriaga Cázares
      • Querétaro, Mexico, 76230
        • Panamerican Clinical Research Mexico
        • Contact:
          • Phone Number: +52 442 333 2898
        • Principal Investigator:
          • Carolina Domínguez Hernández
  • Poland
      • Lodz, Poland, 92-213
        • UMED Clinical Trials
        • Principal Investigator:
          • Agnieszka Szadkowska
        • Contact:
          • Phone Number: +48 42 272 55 55
      • Rzeszów, Poland, 35-301
        • Kliniczny Szpital Wojewódzki Nr 2 im. SW Jadwigi Królowej w Rzeszowie
        • Principal Investigator:
          • Artur Mazur
      • Stanisławów Pierwszy, Poland, 05-126
        • ELIPSA - Elżbieta Lipska praktyka lekarska Ośrodek Endokrynologii i Diabetologii Dziecięcej
        • Principal Investigator:
          • Elzbieta Lipska
        • Contact:
          • Phone Number: +48 796 30 57 57
      • Warsaw, Poland, 03-291
        • Futuremeds Targowek
        • Principal Investigator:
          • Agata Zdanowska
      • Warsaw, Poland, 02 - 696
        • ETG Justmed - PPDS
        • Principal Investigator:
          • Marta Szwarc-Bronikowska
      • Warszewo, Poland, 2117
        • Instytut Diabetologii - Warsaw
        • Principal Investigator:
          • Ewa Pankowska
      • Wroclaw, Poland, 50-414
        • Premium Clinic Wrocław Centrum Medyczne
        • Principal Investigator:
          • Magdalena Bosak Prus
        • Contact:
          • Phone Number: +48512747682
      • Wroclaw, Poland, 53-673
        • Przychodnia FutureMeds Wrocław
        • Principal Investigator:
          • Paulina Ludziak
        • Contact:
          • Phone Number: 887 803 715
  • Portugal
      • Lisbon, Portugal, 1500-650
        • Hospital da Luz Lisboa
        • Principal Investigator:
          • Julia Galhardo
        • Contact:
          • Phone Number: +351 217 104 520
      • Porto, Portugal, 4100-180
        • Hospital Cuf porto
        • Principal Investigator:
          • Carla Rego
        • Contact:
          • Phone Number: (351) 914-6838 x30
      • Porto, Portugal, 4050-651
        • Centro Materno Infantil do Norte
        • Principal Investigator:
          • Helena Mansilha
  • South Korea
      • Seongnam-si, South Korea, 13620
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Jaehyun Kim
      • Seoul, South Korea, 05505
        • Asan Medical Center
        • Principal Investigator:
          • Jin-Ho Choi
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital
        • Principal Investigator:
          • Hyo-Kyoung Nam
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
        • Principal Investigator:
          • Eduard Mogas Vinals
        • Contact:
          • Phone Number: +34 617393140
      • Madrid, Spain, 28009
        • Hospital Infantil Universitario Niño Jesús
        • Principal Investigator:
          • Gabriel Martos-Moreno
        • Contact:
          • Phone Number: +34616531224 ext7351
      • Málaga, Spain, 29011
        • Hospital Regional Universitario de Malaga - Hospital Materno-Infantil
        • Principal Investigator:
          • Isabel Leiva Gea
        • Contact:
          • Phone Number: +34680569397
      • Sabadell, Spain, 8208
        • Corporacio Sanitaria Parc Tauli
        • Principal Investigator:
          • Raquel Corripio Collado
        • Contact:
          • Phone Number: +34937231010 Ex80823
      • Seville, Spain, 41014
        • Instituto Hispalense de Pediatria
        • Principal Investigator:
          • Ignacio Salamanca de la Cueva
      • Vitoria-Gasteiz, Spain, 01009
        • Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
        • Principal Investigator:
          • Ignacio Diez Lopez
        • Contact:
          • Phone Number: +34945007030
  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng-Kung Uni. Hosp.
        • Principal Investigator:
          • Meng-Che Tsai
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
        • Principal Investigator:
          • Yen-Hsuan Ni
      • Taoyuan City, Taiwan, 33305
        • Chang Gung Memorial Hospital - Linkou
        • Principal Investigator:
          • Fu-Sung Lo
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • University of Arizona
        • Principal Investigator:
          • Sunil Sinha
        • Contact:
          • Phone Number: 520-626-8000
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University School of Medicine
        • Principal Investigator:
          • Prashanth Porayette
      • Los Angeles, California, United States, 90095
        • UCLA Mattel Children's Hospital
        • Principal Investigator:
          • Vibha Singhal
      • Los Angeles, California, United States, 90027
        • Childrens Hospital of Los Angeles
        • Principal Investigator:
          • Alaina Vidmar
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
        • Principal Investigator:
          • Amruta Thakkar
        • Contact:
          • Phone Number: 714-509-8824
      • Oxnard, California, United States, 93003-5314
        • Carey Chronis MD Pediatric, Infant and Adolescent Medicine
        • Principal Investigator:
          • Carey Chronis
        • Contact:
          • Phone Number: 805-483-1185 x.947
    • Colorado
      • Colorado Springs, Colorado, United States, 80920-7843
        • Children's Hospital Colorado
        • Principal Investigator:
          • Melanie Cree
    • Connecticut
      • New Haven, Connecticut, United States, 06504
        • Yale New Haven Children's Hospital
        • Principal Investigator:
          • Ania Jastreboff
    • Florida
      • Gainesville, Florida, United States, 32610-3003
        • William A. Shands Hospital at the University of Florida
        • Principal Investigator:
          • Angelina Bernier
      • Orlando, Florida, United States, 32827
        • Nemours Children's Health
        • Principal Investigator:
          • Miles Yu
      • Orlando, Florida, United States, 32803
        • Florida Hospital- Center for Pediatric Research
        • Principal Investigator:
          • Konda Reddy
        • Contact:
          • Phone Number: 407-303-9826
      • Saint Petersburgh, Florida, United States, 33701
        • All Childrens Hospital
        • Principal Investigator:
          • Raquel Hernandez
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Children's Healthcare of Atlanta - Center for Advanced Pediatrics
        • Principal Investigator:
          • Daniel Hsia
        • Contact:
          • Phone Number: 404-785-5686
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
        • Principal Investigator:
          • Shruti Sakhuja
      • Chicago, Illinois, United States, 60611
        • Ann and Robert H Lurie Children's Hospital of Chicago
        • Principal Investigator:
          • Justin Ryder
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children
        • Principal Investigator:
          • Sara Naramore
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Children's Endocrinology
        • Principal Investigator:
          • Sara Watson
        • Contact:
          • Phone Number: 502-588-2590
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Children's Center
        • Principal Investigator:
          • Gihan Naguib
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
        • Principal Investigator:
          • Amy Fleischman
    • Michigan
      • Grand Rapids, Michigan, United States, 49503-2560
        • Helen Devos Childrens' Hospital - PIN
        • Principal Investigator:
          • Miriam Vos
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota Masonic Children's Hospital
        • Principal Investigator:
          • Claudia Fox
        • Contact:
          • Phone Number: (612) 625-3623
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic - PIN
        • Principal Investigator:
          • Seema Kumar
        • Contact:
          • Phone Number: (507) 538-7804
      • Saint Paul, Minnesota, United States, 55102-3354
        • Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center
        • Principal Investigator:
          • Jennifer Abuzzahab
        • Contact:
          • Phone Number: 651-220-5730
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Children's Hospital & Medical Center
        • Principal Investigator:
          • Alvaro Flores Lopez
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
        • Principal Investigator:
          • Steven Ghanny
    • New York
      • Buffalo, New York, United States, 14203
        • UBMD Pediatrics
        • Principal Investigator:
          • Lucy Mastrandrea
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Children's Hospital
        • Principal Investigator:
          • Nina Jain
      • Durham, North Carolina, United States, 27704-2102
        • Duke Children's Primary Care
        • Principal Investigator:
          • Sarah Armstrong
      • Morehead City, North Carolina, United States, 28557
        • Lucas Research, Inc
        • Principal Investigator:
          • Kathryn Lucas
        • Contact:
          • Phone Number: 252-222-5700 ext. 195
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
        • Principal Investigator:
          • ROBERT SIEGEL
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
        • Principal Investigator:
          • Roy Kim
        • Contact:
          • Phone Number: (216) 636-2828
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
        • Principal Investigator:
          • Joan Han
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104-5008
        • Oklahoma Childrens Memorial Hospital
        • Principal Investigator:
          • Jeanie Tryggestad
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Coastal Pediatric Associates
        • Principal Investigator:
          • Stephen Stripling
        • Contact:
          • Phone Number: 843-518-5646
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina Children Hospital - PIN
        • Principal Investigator:
          • Christine San Giovanni
    • Tennessee
      • Nashville, Tennessee, United States, 37204-3609
        • Vanderbilt Health One Hundred Oaks
        • Principal Investigator:
          • Gitanjali Srivastava
    • Texas
      • Austin, Texas, United States, 78723-3079
        • Dell Children's Medical Center - PIN
        • Principal Investigator:
          • Gunjan Dokania
      • Corpus Christi, Texas, United States, 78411
        • Driscoll Children's Hospital
        • Principal Investigator:
          • Ana Paez
      • Houston, Texas, United States, 77030
        • Texas Childrens Hospital
        • Principal Investigator:
          • Stephanie Sisley
      • Houston, Texas, United States, 77030-1521
        • McGovern Medical School
        • Contact:
          • Phone Number: 713-500-7257
        • Principal Investigator:
          • Mona Eissa
    • Virginia
      • Richmond, Virginia, United States, 23229-3156
        • VCU Health - Center for Endocrinology Diabetes and Metabolism
        • Principal Investigator:
          • Edmond Wickham
        • Contact:
          • Phone Number: 804-628-6674
    • Washington
      • Seattle, Washington, United States, 98101
        • Seattle Children's Research Institute - Hughes Building - PIN
        • Principal Investigator:
          • Kalie Tommerdale
        • Contact:
          • Phone Number: (425) 786-3784
      • Tacoma, Washington, United States, 98405
        • MultiCare Health System - Mary Bridge Children's Health Center
        • Principal Investigator:
          • Bhuvana Sunil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tirzepatide
Participants will receive tirzepatide subcutaneously (SC)
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Placebo Comparator: Placebo
Participants will receive placebo SC
Drug: Placebo
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 84
Baseline, Week 84

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Body Weight
Time Frame: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Blood Pressure
Time Frame: Baseline, Week 84
Baseline, Week 84
Percent Change from Baseline in Total Cholesterol
Time Frame: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Fasting Glucose
Time Frame: Baseline, Week 84
Baseline, Week 84
Percent Change from Baseline in Fasting Insulin
Time Frame: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Score
Time Frame: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Child Three-Factor Eating Questionnaire (CTFEQr17) Score
Time Frame: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Height
Time Frame: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Alanine Aminotransferase (ALT)
Time Frame: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Aspartate Aminotransferase (AST)
Time Frame: Baseline, Week 84
Baseline, Week 84
Treatment-Emergent Suicidality from Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Baseline, Week 84
Baseline, Week 84
Pharmacokinetics (PK): Average Tirzepatide Concentration at Steady State (Css)
Time Frame: Baseline through Week 84
Baseline through Week 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

September 9, 2026

First Submitted That Met QC Criteria

September 9, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27090
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • J4M-MC-PWMP Master Protocol (Other Identifier: Eli Lilly and Company)
  • J4M-MC-PW02 (Other Identifier: Eli Lilly and Company)
  • 2025-522020-27-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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