A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Orforglipron
  Administered orally. ISA specific interventions will be listed in the ISA.
• Препарат Placebo
  Administered orally. ISA specific interventions will be listed in the ISA.

Первичные конечные точки

• Number of Participants Allocated to Each ISA [Срок оценки: Baseline to Week 72]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 51 центр

• University of Arizona — Tucson
• Loma Linda University School of Medicine — Loma Linda
• Childrens Hospital of Los Angeles — Los Angeles
• UCLA Mattel Children's Hospital — Los Angeles
• Children's Hospital of Orange County - Orange — Orange
• Carey Chronis MD Pediatric, Infant and Adolescent Medicine — Ventura
• Children's Hospital Colorado — Colorado Springs
• Yale School of Medicine - Yale Diabetes Center (YDC)) Trials — New Haven
• … и ещё 43 центра

Япония · 9 центров

• Saitama Medical University Hospital — Iruma-Gun
• Isesaki Municipal Hospital — Isesaki-shi
• University Hospital,Kyoto Prefectural University of Medicine — Kyoto
• Tokyo Medical Center — Meguro-Ku
• Shiga General Hospital — Moriyama
• Nara Prefecture General Medical Center — Nara
• Osaka City General Hospital — Osaka
• Sagaekiminami Clinic — Saga
• … и ещё 1 центр

Италия · 7 центров

• Azienda Ospedaliero Universitaria Meyer — Florence
• Azienda Ospedaliera Universitaria Policlinico de Modena — Modena
• Azienda Ospedaliero Universitaria Maggiore della Carità — Novara
• Azienda Ospedaliero Universitaria di Parma — Parma
• Ospedale Pediatrico Bambino Gesù — Roma
• Ospedale Pediatrico Bambino Gesù — Roma
• Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento — Verona

Великобритания · 7 центров

Список центров уточняется — проверьте первичный протокол.

Испания · 6 центров

Список центров уточняется — проверьте первичный протокол.

Мексика · 4 центра

• Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC — Culiacán
• PanAmerican Clinical Research - Guadalajara — Guadalajara
• Innovacion y Desarrollo de Estrategias en Salud SA de CV — Mexico City
• Hospital Angeles Puebla — Puebla City

Польша · 4 центра

Список центров уточняется — проверьте первичный протокол.

South Korea · 4 центра

Список центров уточняется — проверьте первичный протокол.

Бельгия · 3 центра

• UZ Brussel — Brussels
• Cliniques Universitaires Saint-Luc - PPDS — Brussels
• UZ Leuven — Leuven

Бразилия · 3 центра

• L2IP - Instituto de Pesquisas Clínicas — Brasília
• Hospital Universitario de Caxias do Sul — Caxias do Sul
• CPQuali Pesquisa Clínica Sao Paulo — São Paulo

Израиль · 3 центра

• Yitzhak Shamir Medical Center — Beer Yaacov
• Shaare Zedek Medical Center — Jerusalem
• Chaim Sheba Medical Center — Ramat Gan

Португалия · 3 центра

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06672549 · 18865 · J4M-MC-PWMP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗