A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
- Registration Number
- NCT06672549
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 125
-
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)
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Orforglipron (ISA PW01) Orforglipron Participants will receive orforglipron or placebo orally. Each ISA will detail the intervention specific. Orforglipron (ISA PW01) Placebo Participants will receive orforglipron or placebo orally. Each ISA will detail the intervention specific.
- Primary Outcome Measures
Name Time Method Number of Participants Allocated to Each ISA Baseline to Week 72
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
Ann and Robert Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Velocity Clinical Research
🇺🇸Omaha, Nebraska, United States
Vanderbilt Health One Hundred Oaks
🇺🇸Nashville, Tennessee, United States
La Providence Pediatrics Clinic - Chemidox Clinical Trials
🇺🇸Houston, Texas, United States
Martin Diagnostic Clinic
🇺🇸Tomball, Texas, United States
Velocity Clinical Research, Salt Lake City
🇺🇸West Jordan, Utah, United States
L2IP - Instituto de Pesquisas Clínicas
🇧🇷Brasília, Distrito Federal, Brazil
Hospital Universitario de Caxias do Sul
🇧🇷Caxias do Sul, Rio Grande Do Sul, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
🇧🇷Ribeirão Preto, Sao Paulo, Brazil
CPQuali Pesquisa Clínica Sao Paulo
🇧🇷Sao Paulo, Brazil
Yitzhak Shamir Medical Center
🇮🇱Beer Yaacov, HaMerkaz, Israel
Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC
🇲🇽Culiacan, Mexico
Hospital Angeles Puebla
🇲🇽Puebla, Mexico
Instytut Diabetologii
🇵🇱Warsaw, Mazowieckie, Poland
Krakowskie Centrum Medyczne
🇵🇱Krakow, Poland
FutureMeds - Targowek
🇵🇱Warszawa, Poland
FutureMeds sp. z o. o.
🇵🇱Wroclaw, Poland
Bristol Royal Hospital for Children
🇬🇧Bristol, Bristol, City Of, United Kingdom
Addenbrookes Hospital
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Hull Royal Infirmary - MAIN
🇬🇧Hull, Kingston U, United Kingdom
Northwick Park Hospital
🇬🇧Harrow, Middlesex, United Kingdom
Ninewells Hospital
🇬🇧Dundee, Scotland, United Kingdom
Barnsley Hospital NHS Foundation Trust
🇬🇧Barnsley, United Kingdom
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
🇺🇸Ventura, California, United States
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
🇺🇸New Haven, Connecticut, United States
Stamford Therapeutics Consortium
🇺🇸Stamford, Connecticut, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
🇺🇸Atlanta, Georgia, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
🇺🇸Houston, Texas, United States
Sundance Clinical Research
🇺🇸Saint Louis, Missouri, United States
Lucas Research, Inc
🇺🇸Morehead City, North Carolina, United States
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Shaare Zedek Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Azienda Ospedaliero Universitaria Meyer
🇮🇹Firenze, Toscana, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
🇮🇹Verona, Veneto, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
🇮🇹Novara, Italy
Ospedale Pediatrico Bambino Gesù
🇮🇹Roma, Italy
Osaka City General Hospital
🇯🇵Osaka, Japan
Sagaekiminami Clinic
🇯🇵Saga-shi, Japan
PanAmerican Clinical Research - Guadalajara
🇲🇽Guadalajara, Jalisco, Mexico
Alder Hey Children's Hospital
🇬🇧Liverpool, United Kingdom