Clinical trial
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Recruiting now · Phase 3 · 8 countries · Registry ID NCT06672549
Recruiting nowPhase 3Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age6 Years to 17 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight
Full registry criteria
Inclusion Criteria: * 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 * dyslipidemia * obstructive sleep apnea * metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD) Exclusion Criteria: * 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 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.
Treatments and study arms
Orforglipron
Drug
Administered orally. ISA specific interventions will be listed in the ISA.
Placebo
Drug
Administered orally. ISA specific interventions will be listed in the ISA.
Primary outcomes
Number of Participants Allocated to Each ISABaseline to Week 72
Study locations
117 locations were listed when this page was built. The first 40 are shown.
Cliniques Universitaires Saint-Luc - PPDS🇧🇪 Brussels, Belgium
Philippe LysyPrincipal Investigator
L2IP - Instituto de Pesquisas Clínicas🇧🇷 Brasília, Brazil
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Eduardo VasconcellosPrincipal Investigator
Hospital Universitario de Caxias do Sul🇧🇷 Caxias do Sul, Brazil
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Marcia Inês Boff RissottoPrincipal Investigator
CPQuali Pesquisa Clínica Sao Paulo🇧🇷 São Paulo, Brazil
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Francisco Samuel Magalhaes LimaPrincipal Investigator
Chang Gung Medical Foundation-Linkou Branch🇨🇳 Taoyuan, China
Fu-Sung LoPrincipal Investigator
Yitzhak Shamir Medical Center🇮🇱 Beer Yaacov, Israel
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Marianna RachmielPrincipal Investigator
Rambam Health Care Campus🇮🇱 Haifa, Israel
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Ram WeissPrincipal Investigator
Hadassah Medical Center🇮🇱 Jerusalem, Israel
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David ZangenPrincipal Investigator
Shaare Zedek Medical Center🇮🇱 Jerusalem, Israel
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Floris Levy-KhademiPrincipal Investigator
Schneider Children's Medical Center🇮🇱 Petah Tikva, Israel
Moshe PhillipPrincipal Investigator
Chaim Sheba Medical Center🇮🇱 Ramat Gan, Israel
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Noah GruberPrincipal Investigator
Azienda Ospedaliero Universitaria Meyer🇮🇹 Florence, Italy
Stefano StagiPrincipal Investigator
Azienda Ospedaliera Universitaria Policlinico de Modena🇮🇹 Modena, Italy
Barbara PredieriPrincipal Investigator
Azienda Ospedaliero Universitaria Maggiore della Carità🇮🇹 Novara, Italy
Ivana RabbonePrincipal Investigator
Azienda Ospedaliero Universitaria di Parma🇮🇹 Parma, Italy
Maria Elisabeth StreetPrincipal Investigator
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento🇮🇹 Verona, Italy
Claudio MaffeisPrincipal Investigator
Saitama Medical University Hospital🇯🇵 Iruma-Gun, Japan
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Toru KikuchiPrincipal Investigator
Isesaki Municipal Hospital🇯🇵 Isesaki-shi, Japan
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Yoko TakanoPrincipal Investigator
University Hospital,Kyoto Prefectural University of Medicine🇯🇵 Kyoto, Japan
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Satoru SugimotoPrincipal Investigator
Tokyo Medical Center🇯🇵 Meguro-Ku, Japan
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Masashi MiharuPrincipal Investigator
Shiga General Hospital🇯🇵 Moriyama, Japan
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Katsuyuki MatsuiPrincipal Investigator
Nara Prefecture General Medical Center🇯🇵 Nara, Japan
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Sayaka YoshidaPrincipal Investigator
Osaka City General Hospital🇯🇵 Osaka, Japan
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Jun MoriPrincipal Investigator
Sagaekiminami Clinic🇯🇵 Saga, Japan
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Tateo KunoPrincipal Investigator
Shikoku Medical Center for Children and Adults🇯🇵 Zentsujichó, Japan
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Takafumi OkadaPrincipal Investigator
Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC🇲🇽 Culiacán, Mexico
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Angeles Rodriguez SanchezPrincipal Investigator
PanAmerican Clinical Research - Guadalajara🇲🇽 Guadalajara, Mexico
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Ana Lopez BeltranPrincipal Investigator
PanAmerican Clinical Research - Av. Antea 1032 - PPDS🇲🇽 Juriquilla, Mexico
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Carolina Domínguez HernándezPrincipal Investigator
Centro de Investigacion Farmacologica Del Bajio Sc🇲🇽 León, Mexico
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Catalina Peralta CortázarPrincipal Investigator
Innovacion y Desarrollo de Estrategias en Salud SA de CV🇲🇽 Mexico City, Mexico
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Veronica Garcia SamanoPrincipal Investigator
Hospital Angeles Puebla🇲🇽 Puebla City, Mexico
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Margarita BarrientosPrincipal Investigator
Kliniczny Szpital Wojewódzki Nr 2 im. SW Jadwigi Królowej w Rzeszowie🇵🇱 Rzeszów, Poland
Artur MazurPrincipal Investigator