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

Phase 3

Recruiting

• Conditions: Obesity; Overweight
• Interventions: Drug: Orforglipron; Drug: Placebo

• 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.

Study Timeline

• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Study Start: 2024-11-18
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-23
• Primary Completion: 2027-02
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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.

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

Trial Locations

Locations (35)

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

Ann and Robert Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Velocity Clinical Research; 🇺🇸 Omaha, Nebraska, 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

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