ObesityPhase 3ADVANCENCT06672549
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
A Phase 3 study testing Orforglipron in people with Obesity and Overweight, run by Eli Lilly and Company at 116 sites in 13 countries.
Trial summary
The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Orforglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 116 sitesin 13 countries
- Study dates
- 18 Nov 2024to Mar 2027
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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]); OR
- Applies to participant age between 12 and <18 years old. Overweight as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart (CDC-NCHS, 2022), and at least 1 weight-related comorbidity,
- hypertension
- type 2 diabetes (T2D)
- prediabetes
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- dyslipidemia
- obstructive sleep apnea
- metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD)
Who cannot join
- 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.
Show all 10Show fewer
- Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- 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
116 sites in 13 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
116 sites in 13 countries
United States50 sites, 50 recruiting
- Not yet recruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, 30329
404-712-4731; 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 Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
312-503-1499
Justin Ryder
- Not yet recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
773-702-2879
Shruti Sakhuja
- 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
616-486-6113
Miriam Vos
- Not yet recruiting
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Gulfport, Mississippi, 39503-2637
228-206-1283
Paul Matherne
- 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
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Houston, Texas, 77065
281-517-0550
Kashif Ali
- Not yet recruiting
La Providence Pediatrics Clinic - Chemidox Clinical Trials
Houston, Texas, 77071-1008
833-324-3643
Ifeyinwa Onwudiwe
- Not yet recruiting
Riley Hospital for Children
Indianapolis, Indiana, 46202
Sara Naramore
- Not yet recruiting
Velocity Clinical Research
Lafayette, Louisiana, 70508
337-519-4742
Jibran Atwi
- 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
- 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
615-322-6000
Jennifer Kelley
- Not yet recruiting
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
New Haven, Connecticut, 06519
203-410-8509
Michelle Van Name
- Not yet recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Jeanie Tryggestad
- Not yet recruiting
Omaha Childrens Hospital
Omaha, Nebraska, 68114
Alvaro Flores Lopez
- Not yet recruiting
Velocity Clinical Research
Omaha, Nebraska, 68134
402-933-6500
Brandon Essink
- Not yet recruiting
Children's Hospital of Orange County - Orange
Orange, California, 92868
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
- Not yet recruiting
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Oxnard, California, 93030
805-483-1185 x.947
Carey Chronis
- Not yet recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
412-692-6935
Silva Arslanian
- 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
Sundance Clinical Research
St Louis, Missouri, 63141-7068
314-567-3377
Delores Chantal Dotson
- Not yet recruiting
All Childrens Hospital
St. Petersburg, Florida, 33701
727-767-2389
Raquel Hernandez
- Not yet recruiting
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
727-544-4842
David Radin
- Not yet recruiting
MultiCare Health System - Mary Bridge Children's Health Center
Tacoma, Washington, 98405
253-403-0776
Bhuvana Sunil
- Not yet recruiting
Martin Diagnostic Clinic
Tomball, Texas, 77375-3332
281-517-0550
Helen Shpats
- Not yet recruiting
University of Arizona
Tucson, Arizona, 85721
520-626-8000
Sunil Sinha
- Not yet recruiting
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
801-542-8190
Barbara Rizzardi
Japan9 sites, 9 recruiting
- Not yet recruiting
Saitama Medical University Hospital
Iruma-Gun, 350-0495
81120023812
Toru Kikuchi
- Not yet recruiting
Isesaki Municipal Hospital
Isesaki-shi, 372-0817
81120023812
Yoko Takano
- Not yet recruiting
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, 602-8566
81120023812
Satoru Sugimoto
- Not yet recruiting
Tokyo Medical Center
Meguro-Ku, 152-0021
81120023812
Masashi Miharu
- Not yet recruiting
Shiga General Hospital
Moriyama, 524-8524
81120023812
Katsuyuki Matsui
- Not yet recruiting
Nara Prefecture General Medical Center
Nara, 630-8054
81120023812
Sayaka Yoshida
- Not yet recruiting
Osaka City General Hospital
Osaka, 534-0021
81120023812
Jun Mori
- Not yet recruiting
Sagaekiminami Clinic
Saga, 840-0801
81120023812
Tateo Kuno
- Not yet recruiting
Shikoku Medical Center for Children and Adults
Zentsujichó, 765-8507
81120023812
Takafumi Okada
Poland9 sites, 9 recruiting
- Not yet recruiting
Krakowskie Centrum Medyczne
Krakow, 31-501
Ewelina Malec
- Not yet recruiting
UMED Clinical Trials
Lodz, 92-213
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
Elzbieta Lipska
- Not yet recruiting
ETG Justmed - PPDS
Warsaw, 02 - 696
Marta Szwarc-Bronikowska
- Not yet recruiting
Instytut Diabetologii
Warsaw, 02-117
Ewa Pankowska
- Not yet recruiting
FutureMeds - Targowek
Warsaw, 03-291
Anna Liber
- Not yet recruiting
Premium Clinic Wrocław Centrum Medyczne
Wroclaw, 50-414
Magdalena Bosak Prus
- Not yet recruiting
FutureMeds sp. z o. o.
Wroclaw, 53-673
Paulina Ludziak
Italy7 sites, 7 recruiting
- Not yet recruiting
Azienda Ospedaliero Universitaria Meyer
Florence, 50139
Stefano Stagi
- Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico de Modena
Modena, 41124
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
Maria Elisabeth Street
- Not yet recruiting
Ospedale Pediatrico Bambino Gesù
Roma, 165
Marco Cappa
- Not yet recruiting
Ospedale Pediatrico Bambino Gesù
Roma, 165
Danilo Fintini
- Not yet recruiting
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, 37126
Claudio Maffeis
United Kingdom7 sites, 7 recruiting
- Not yet recruiting
Barnsley Hospital NHS Foundation Trust
Barnsley, S75 2EP
01226 432860
Rajeev Gupta
- Not yet recruiting
Bristol Royal Hospital for Children
Bristol, BS2 8BJ
0117 342 0183
Dinesh Giri
- Not yet recruiting
Addenbrookes Hospital
Cambridge, CB2 0QQ
07824 302285
Ken Ong
- Not yet recruiting
Ninewells Hospital
Dundee, DD1 9SY
(44138) 238-8385
Nicholas Conway
- Not yet recruiting
Northwick Park Hospital
Harrow, HA1 3UJ
020 8864 3232
Nilanjana Ray
- Not yet recruiting
Hull Royal Infirmary - MAIN
Hull, HU3 2JZ
01482 875875
Sanjay Gupta
- Not yet recruiting
Alder Hey Children's Hospital
Liverpool, L14 5AB
(447) 971-6250
Senthil Senniappan
Israel6 sites, 6 recruiting
- Not yet recruiting
Yitzhak Shamir Medical Center
Beer Yaacov, 70300
972537346636
Marianna Rachmiel
- Not yet recruiting
Rambam Health Care Campus
Haifa, 3109601
+9729582036
Ram Weiss
- Not yet recruiting
Shaare Zedek Medical Center
Jerusalem, 9013102
972504021504
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
- Not yet recruiting
Chaim Sheba Medical Center
Ramat Gan, 5262100
97235305015
Noah Gruber
Mexico6 sites, 6 recruiting
- Not yet recruiting
Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC
Culiacán, 80000
(+52) 55 5402 9474
Angeles Rodriguez Sanchez
- Not yet recruiting
PanAmerican Clinical Research - Guadalajara
Guadalajara, 44670
33 16 05 20 31
Ana Lopez Beltran
- Not yet recruiting
PanAmerican Clinical Research - Av. Antea 1032 - PPDS
Juriquilla, 76230
+52 442 333 2898
Carolina Domínguez Hernández
- Not yet recruiting
Centro de Investigacion Farmacologica Del Bajio Sc
León, 37160
4773933523
Catalina Peralta Cortázar
- Not yet recruiting
Innovacion y Desarrollo de Estrategias en Salud SA de CV
Mexico City, 14090
5536558005
Veronica Garcia Samano
- Not yet recruiting
Hospital Angeles Puebla
Puebla City, 72190
22 22 65 73 19
Margarita Barrientos
Spain6 sites, 6 recruiting
- Not yet recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Eduard Mogas Vinals
- Not yet recruiting
Hospital Infantil Universitario Niño Jesús
Madrid, 28009
Gabriel Martos-Moreno
- Not yet recruiting
Hospital Regional Universitario de Malaga - Hospital Materno-Infantil
Málaga, 29011
Isabel Leiva Gea
- Not yet recruiting
Corporacio Sanitaria Parc Tauli
Sabadell, 8208
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
Ignacio Diez Lopez
South Korea4 sites, 4 recruiting
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13620
Jaehyun Kim
- Not yet recruiting
Hanyang University Seoul Hospital
Seoul, 04763
Seung Yang
- Not yet recruiting
Korea University Guro Hospital
Seoul, 08308
Hyo-Kyoung Nam
- Not yet recruiting
Asan Medical Center
Seoul, 5505
Jin-Ho Choi
Belgium3 sites, 3 recruiting
- Not yet recruiting
UZ Brussel
Brussels, 1090
Inge Gies
- Not yet recruiting
Cliniques Universitaires Saint-Luc - PPDS
Brussels, 1200
Philippe Lysy
- Not yet recruiting
UZ Leuven
Leuven, 3000
Kristina Casteels
Brazil3 sites, 3 recruiting
- Not yet recruiting
L2IP - Instituto de Pesquisas Clínicas
Brasília, 70200730
556134454300
Eduardo Vasconcellos
- Not yet recruiting
Hospital Universitario de Caxias do Sul
Caxias do Sul, 95070-560
(555) 432-1827 x37
Marcia Inês Boff Rissotto
- Not yet recruiting
CPQuali Pesquisa Clínica Sao Paulo
São Paulo, 01228-000
551127766801
Francisco Samuel Magalhaes Lima
China3 sites, 3 recruiting
- Not yet recruiting
National Cheng Kung University Hospital
Tainan, 704
Meng-Che Tsai
- Not yet recruiting
National Taiwan University Hospital
Taipei, 10002
Yen-Hsuan Ni
- Not yet recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 33305
Fu-Sung Lo
Portugal3 sites, 3 recruiting
- Not yet recruiting
Hospital da Luz Lisboa
Lisbon, 1500-650
Julia Galhardo
- Not yet recruiting
Centro Materno Infantil do Norte
Porto, 4050-651
Helena Mansilha
- Not yet recruiting
Hospital CUF Porto
Porto, 4100-180
Carla Rego
About this study
Official title: A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight
The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.
Read the detailed description
The PWMP establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. PWMP results will be reported when all the ISA's complete.
- Conditions
- Obesity, Overweight
- Being tested
- Orforglipron, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrforglipronDrug
Also called LY3502970
Administered orally. ISA specific interventions will be listed in the ISA.
PlaceboDrug
Administered orally. ISA specific interventions will be listed in the ISA.
| Study group | Role | What they receive |
|---|---|---|
| Orforglipron (ISA PW01) | Experimental | Participants will receive orforglipron or placebo orally. Each ISA will detail the intervention specific. Receives: Drug: Orforglipron; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Allocated to Each ISA
Measured: Baseline to Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start18 Nov 2024
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The PWMP protocol includes screening assessments plus a framework for the subsequent intervention, which is the primary purpose of the protocol.
- Masking
- None (open label)
- Enrolment
- 125 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
- NCT06672549
- Sponsor's protocol ID
- 18865
- Other IDs
- J4M-MC-PWMP
- Acronym
- ADVANCE
- Status last verified
- Oct 2026
- First submitted
- 1 Nov 2024
- Last updated
- 7 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.