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

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

Overview

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.

Interventions

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

Primary outcome measures

• Number of Participants Allocated to Each ISA [Time frame: Baseline to Week 72]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Screening

Study locations

United States · 51 centers

• 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
• … and 43 more centers

Japan · 9 centers

• 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
• … and 1 more center

Italy · 7 centers

• 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

United Kingdom · 7 centers

Center list to be confirmed — check the primary protocol.

Spain · 6 centers

Center list to be confirmed — check the primary protocol.

Mexico · 4 centers

• 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

Poland · 4 centers

Center list to be confirmed — check the primary protocol.

South Korea · 4 centers

Center list to be confirmed — check the primary protocol.

Belgium · 3 centers

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

Brazil · 3 centers

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

Israel · 3 centers

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

Portugal · 3 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06672549 · 18865 · J4M-MC-PWMP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗