ObesityPhase 3NCT07817875
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)
A Phase 3 study testing Tirzepatide in people with Obesity, run by Eli Lilly and Company at 82 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Obesity
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 82 sitesin 10 countries
- Study dates
- 25 Sep 2026to Dec 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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])
Who cannot join
- J4M-MC-PW02
- Have a history of
- proliferative diabetic retinopathy
- diabetic macular edema, or
- nonproliferative diabetic retinopathy that requires acute treatment
- J4M-MC-PWMP
Show all 15Show fewer
- 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.
Trial locations and contacts
82 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
82 sites in 10 countries
United States41 sites, 41 recruiting
- Not yet recruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, 30329
404-785-5686
Daniel Hsia
- Not yet recruiting
Dell Children's Medical Center - PIN
Austin, Texas, 78723-3079
Gunjan Dokania
- Not yet recruiting
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
410-955-8769
Gihan Naguib
- Not yet recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Margaret Stefater-Richards
- Not yet recruiting
UBMD Pediatrics
Buffalo, New York, 14203
Lucy Mastrandrea
- Not yet recruiting
UNC Children's Hospital
Chapel Hill, North Carolina, 27514
Nina Jain
- Not yet recruiting
Coastal Pediatric Associates
Charleston, South Carolina, 29414
843-518-5646
Stephen Stripling
- Not yet recruiting
Medical University of South Carolina Children Hospital
Charleston, South Carolina, 29425
843-792-0603
Christine San Giovanni
- Not yet recruiting
Ann and Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
630-642-9702. 312-227-3604
Justin Ryder
- Not yet recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
773-702-2879
Shruti Sakhuja
- Not yet recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
ROBERT SIEGEL
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
216-636-2828
Roy Kim
- Not yet recruiting
Children's Hospital Colorado
Colorado Springs, Colorado, 80920-7843
Melanie Cree
- Not yet recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Joan Han
- Not yet recruiting
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
361-694-4455
Ana Paez
- Not yet recruiting
Duke Children's Primary Care
Durham, North Carolina, 27704-2102
Sarah Armstrong
- Not yet recruiting
Helen Devos Childrens' Hospital - PIN
Grand Rapids, Michigan, 49503-2560
Miriam Vos
- Not yet recruiting
McGovern Medical School
Houston, Texas, 77030-1521
713-500-7257
Mona Eissa
- Not yet recruiting
Texas Childrens Hospital
Houston, Texas, 77030
713-798-0391
Stephanie Sisley
- Not yet recruiting
Riley Hospital for Children
Indianapolis, Indiana, 46202
Sara Naramore
- Not yet recruiting
Loma Linda University School of Medicine
Loma Linda, California, 92354
Prashanth Porayette
- Not yet recruiting
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
Alaina Vidmar
- Not yet recruiting
UCLA Mattel Children's Hospital
Los Angeles, California, 90095
Vibha Singhal
- Not yet recruiting
Norton Children's Endocrinology
Louisville, Kentucky, 40202
502-588-2590
Sara Watson
- Not yet recruiting
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55454
612-625-3623
Claudia Fox
- Not yet recruiting
Lucas Research, Inc
Morehead City, North Carolina, 28557
252-222-5700 ext. 195
Kathryn Lucas
- Not yet recruiting
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, 37204-3609
Jennifer Kelley
- Not yet recruiting
Yale New Haven Children's Hospital
New Haven, Connecticut, 06504
203-410-8509
Michelle Van Name
- Not yet recruiting
Oklahoma Childrens Memorial Hospital
Oklahoma City, Oklahoma, 73104-5008
Jeanie Tryggestad
- Not yet recruiting
Children's Hospital & Medical Center
Omaha, Nebraska, 68114
Alvaro Flores Lopez
- Not yet recruiting
Children's Hospital of Orange County
Orange, California, 92868
714-509-8824
Amruta Thakkar
- Not yet recruiting
Florida Hospital- Center for Pediatric Research
Orlando, Florida, 32803
407-303-9826
Konda Reddy
- Not yet recruiting
Nemours Children's Health
Orlando, Florida, 32827
Miles Yu
- Recruiting
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Oxnard, California, 93003-5314
805-483-1185 x.947
Carey Chronis
- Not yet recruiting
VCU Health - Center for Endocrinology Diabetes and Metabolism
Richmond, Virginia, 23229-3156
804-628-6674
Edmond Wickham
- Not yet recruiting
Mayo Clinic - PIN
Rochester, Minnesota, 55905-0001
507-538-7804
Seema Kumar
- Not yet recruiting
Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center
Saint Paul, Minnesota, 55102-3354
651-220-5730
Jennifer Abuzzahab
- Not yet recruiting
Seattle Children's Research Institute - Hughes Building - PIN
Seattle, Washington, 98101
425-786-3784
Kalie Tommerdale
- Not yet recruiting
All Childrens Hospital
St. Petersburg, Florida, 33701
727-767-2389
Raquel Hernandez
- Not yet recruiting
MultiCare Health System - Mary Bridge Children's Health Center
Tacoma, Washington, 98405
253-403-0776
Bhuvana Sunil
- Not yet recruiting
University of Arizona
Tucson, Arizona, 85721
520-626-8000
Sunil Sinha
Poland8 sites, 8 recruiting
- Not yet recruiting
UMED Clinical Trials
Lodz, 92-213
+48 42 272 55 55
Agnieszka Szadkowska
- Not yet recruiting
Kliniczny Szpital Wojewódzki Nr 2 im. SW Jadwigi Królowej w Rzeszowie
Rzeszów, 35-301
Artur Mazur
- Not yet recruiting
ELIPSA - Elżbieta Lipska praktyka lekarska Ośrodek Endokrynologii i Diabetologii Dziecięcej
Stanisławów Pierwszy, 05-126
+48 796 30 57 57
Elzbieta Lipska
- Not yet recruiting
ETG Justmed - PPDS
Warsaw, 02 - 696
Marta Szwarc-Bronikowska
- Not yet recruiting
Futuremeds Targowek
Warsaw, 03-291
Agata Zdanowska
- Not yet recruiting
Instytut Diabetologii - Warsaw
Warszewo, 2117
Ewa Pankowska
- Not yet recruiting
Premium Clinic Wrocław Centrum Medyczne
Wroclaw, 50-414
+48512747682
Magdalena Bosak Prus
- Not yet recruiting
Przychodnia FutureMeds Wrocław
Wroclaw, 53-673
887 803 715
Paulina Ludziak
Israel6 sites, 6 recruiting
- Not yet recruiting
Shamir Medical Center
Beer Jacob, 73100
Marianna Rachmiel
- Not yet recruiting
Soroka Medical Center
Beersheba, 8410101
Alon Haim
- Not yet recruiting
Rambam Health Care Campus
Haifa, 3109601
Ram Weiss
- Not yet recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
Floris Levy-Khademi
- Not yet recruiting
Hadassah Medical Center
Jerusalem, 9112001
+972526444664
David Zangen
- Not yet recruiting
Schneider Children's Medical Center
Petah Tikva, 4920235
Moshe Phillip
Spain6 sites, 6 recruiting
- Not yet recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
+34 617393140
Eduard Mogas Vinals
- Not yet recruiting
Hospital Infantil Universitario Niño Jesús
Madrid, 28009
+34616531224 ext7351
Gabriel Martos-Moreno
- Not yet recruiting
Hospital Regional Universitario de Malaga - Hospital Materno-Infantil
Málaga, 29011
+34680569397
Isabel Leiva Gea
- Not yet recruiting
Corporacio Sanitaria Parc Tauli
Sabadell, 8208
+34937231010 Ex80823
Raquel Corripio Collado
- Not yet recruiting
Instituto Hispalense de Pediatria
Seville, 41014
Ignacio Salamanca de la Cueva
- Not yet recruiting
Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
Vitoria-Gasteiz, 01009
+34945007030
Ignacio Diez Lopez
Italy5 sites, 5 recruiting
- Not yet recruiting
Azienda Ospedaliero Universitaria Meyer
Florence, 50139
+390555662305
Stefano Stagi
- Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico de Modena
Modena, 41124
+39 059 422 5217
Barbara Predieri
- Not yet recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
Ivana Rabbone
- Not yet recruiting
Azienda Ospedaliero Universitaria di Parma
Parma, 43126
+393206069875
Maria Elisabeth Street
- Not yet recruiting
Ospedale Pediatrico Bambino Gesù
Roma, 165
+39 0668593149
Danilo Fintini
Mexico4 sites, 4 recruiting
- Not yet recruiting
PanAmerican Clinical Research - Guadalajara
Guadalajara, 44670
+52 3310079299
Ana Lopez Beltran
- Not yet recruiting
Centro de Investigacion Farmacologica Del Bajio Sc
León, 37160
4773933523
Catalina Peralta Cortázar
- Not yet recruiting
Christus - Latam Hub Center of Excellence and Innovation S.C.
Monterrey, 64060
8183993400 Ext. 3652
Hector Arriaga Cázares
- Not yet recruiting
Panamerican Clinical Research Mexico
Querétaro, 76230
+52 442 333 2898
Carolina Domínguez Hernández
Belgium3 sites, 3 recruiting
- Not yet recruiting
Cliniques Universitaires Saint-Luc - PPDS
Brussels, 1200
Philippe Lysy
- Not yet recruiting
UZ Brussel
Jette, 1090
Inge Gies
- Not yet recruiting
UZ Leuven
Leuven, 3000
Kristina Casteels
Portugal3 sites, 3 recruiting
- Not yet recruiting
Hospital da Luz Lisboa
Lisbon, 1500-650
+351 217 104 520
Julia Galhardo
- Not yet recruiting
Centro Materno Infantil do Norte
Porto, 4050-651
Helena Mansilha
- Not yet recruiting
Hospital CUF Porto
Porto, 4100-180
(351) 914-6838 x30
Carla Rego
South Korea3 sites, 3 recruiting
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13620
Jaehyun Kim
- Not yet recruiting
Asan Medical Center
Seoul, 05505
Jin-Ho Choi
- Not yet recruiting
Korea University Guro Hospital
Seoul, 08308
Hyo-Kyoung Nam
Taiwan3 sites, 3 recruiting
- Not yet recruiting
National Cheng-Kung Uni. Hosp.
Tainan, 704
Meng-Che Tsai
- Not yet recruiting
National Taiwan University Hospital
Taipei, 10002
Yen-Hsuan Ni
- Not yet recruiting
Chang Gung Memorial Hospital - Linkou
Taoyuan City, 33305
Fu-Sung Lo
About this study
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
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.
- Conditions
- Obesity
- Being tested
- Tirzepatide, Placebo
- Keywords
- Pediatric, Children
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | Participants will receive tirzepatide subcutaneously (SC) Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | Participants will receive placebo SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Body Mass Index (BMI)
Measured: Baseline, Week 84
Secondary outcomes (13)
Change from Baseline in Body Weight
Measured: Baseline, Week 84
Change from Baseline in Waist Circumference
Measured: Baseline, Week 84
Change from Baseline in Blood Pressure
Measured: Baseline, Week 84
Percent Change from Baseline in Total Cholesterol
Measured: Baseline, Week 84
Change from Baseline in Fasting Glucose
Measured: Baseline, Week 84
Percent Change from Baseline in Fasting Insulin
Measured: Baseline, Week 84
Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Score
Measured: Baseline, Week 84
Change from Baseline in Child Three-Factor Eating Questionnaire (CTFEQr17) Score
Measured: Baseline, Week 84
Change from Baseline in Height
Measured: Baseline, Week 84
Change from Baseline in Alanine Aminotransferase (ALT)
Measured: Baseline, Week 84
Change from Baseline in Aspartate Aminotransferase (AST)
Measured: Baseline, Week 84
Treatment-Emergent Suicidality from Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Baseline, Week 84
Pharmacokinetics (PK): Average Tirzepatide Concentration at Steady State (Css)
Measured: Baseline through Week 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start25 Sep 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817875
- Sponsor's protocol ID
- 27090
- Other IDs
- J4M-MC-PW02, J4M-MC-PWMP Master Protocol, 2025-522020-27-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.