Clinical trial NCT06672549: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Obesity
Overweight
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 125
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The PWMP protocol includes screening assessments plus a framework for the subsequent intervention, which is the primary purpose of the protocol.
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Number of Participants Allocated to Each ISA
timeFrame: Baseline to Week 72
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Carey Chronis MD Pediatric, Infant and Adolescent Medicine
state: California
city: New Haven
country: United States
facility: Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Center for Advanced Pediatrics
state: Georgia
city: Chicago
country: United States
facility: Ann and Robert Lurie Children's Hospital of Chicago
state: Illinois
city: Lafayette
country: United States
facility: Velocity Clinical Research
state: Louisiana
city: Gulfport
country: United States
facility: Dynamed Clinical Research, LP d/b/a DM Clinical Research
state: Mississippi
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Omaha
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Morehead City
country: United States
facility: Lucas Research, Inc
state: North Carolina
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Health One Hundred Oaks
state: Tennessee
city: Houston
country: United States
facility: Dynamed Clinical Research, LP d/b/a DM Clinical Research
state: Texas
city: Houston
country: United States
facility: La Providence Pediatrics Clinic - Chemidox Clinical Trials
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: Brasília
country: Brazil
facility: L2IP - Instituto de Pesquisas Clínicas
state: Distrito Federal
city: Caxias do Sul
country: Brazil
facility: Hospital Universitario de Caxias do Sul
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica Sao Paulo
city: Beer Yaacov
country: Israel
facility: Yitzhak Shamir Medical Center
state: HaMerkaz
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Meyer
state: Toscana
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
state: Veneto
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
city: Warsaw
country: Poland
facility: Instytut Diabetologii
state: Mazowieckie
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne
city: Warszawa
country: Poland
facility: FutureMeds - Targowek
city: Wroclaw
country: Poland
facility: FutureMeds sp. z o. o.
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
state: Bristol, City Of
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
state: Cambridgeshire
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary - MAIN
state: Kingston U
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
state: Middlesex
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Scotland
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: