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NCT06672549

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

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-18

Study Completion Date

2027-03-31

Brief Summary

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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

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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.

Conditions

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Obesity Overweight

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

The PWMP protocol includes screening assessments plus a framework for the subsequent intervention, which is the primary purpose of the protocol.

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Orforglipron (ISA PW01)

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

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Interventions

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Orforglipron

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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LY3502970

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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