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Phase 3Recruiting

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

Sponsored by Eli Lilly and Company

About this study

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.

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.

Where this study is enrolling (18)

  • University of Arizona

    Tucson, Arizona

    I'm interested

  • Carey Chronis MD Pediatric, Infant and Adolescent Medicine

    Oxnard, California

    Call 805-483-1185 x.947

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  • Stamford Therapeutics Consortium

    Stamford, Connecticut

    Call 727-544-4842

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  • Yale School of Medicine - Yale Diabetes Center (YDC)) Trials

    New Haven, Connecticut

    Call ania.jastreboff@yale.edu

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  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics

    Atlanta, Georgia

    Call 404-256-2593

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Show all 18 locations

  • Ann and Robert Lurie Children's Hospital of Chicago

    Chicago, Illinois

    I'm interested

  • Velocity Clinical Research

    Lafayette, Louisiana

    Call 337-519-4742

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  • Dynamed Clinical Research, LP d/b/a DM Clinical Research

    Gulfport, Mississippi

    Call 228-206-1283

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  • Sundance Clinical Research

    St Louis, Missouri

    Call 314-567-3377

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  • Velocity Clinical Research

    Omaha, Nebraska

    Call 402-933-6500

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  • Lucas Research, Inc

    Morehead City, North Carolina

    Call 252-222-5700

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  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania

    Call 412-692-6935

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  • Vanderbilt Health One Hundred Oaks

    Nashville, Tennessee

    Call 615-322-6000

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  • La Providence Pediatrics Clinic - Chemidox Clinical Trials

    Houston, Texas

    Call 713-981-6002

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  • Martin Diagnostic Clinic

    Tomball, Texas

    Call 281-517-0550

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  • McGovern Medical School

    Houston, Texas

    Call 713-500-5010

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  • Dynamed Clinical Research, LP d/b/a DM Clinical Research

    Houston, Texas

    I'm interested

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah

    Call 801-542-8190

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Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.