Recruiting
Phase 3

LY900040

Sponsor:

Eli Lilly and Company

Code:

NCT06672549

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Orforglipron

Placebo

Study Details

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.

Conditions

Obesity

Overweight

Study ID

NCT06672549

Start date

Nov 18, 2024

Status verified date

Aug, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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

Enrollment

125 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Orforglipron (ISA PW01)

Participants will receive orforglipron or placebo orally. Each ISA will detail the intervention specific.

Interventions

Orforglipron

Administered orally. ISA specific interventions will be listed in the ISA.

Placebo

Administered orally. ISA specific interventions will be listed in the ISA.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Lucas Research, Inc

Recruiting

Morehead City, North Carolina, United States, 28557

Contacts

252-222-5700

Principal Investigator:

Kathryn Lucas

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-24.