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Purpose

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

Eligibility

Eligible Ages
Between 6 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
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
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Orforglipron (ISA PW01) 		Participants will receive orforglipron or placebo orally. Each ISA will detail the intervention specific.
  • Drug: Orforglipron
    Administered orally. ISA specific interventions will be listed in the ISA.
    Other names:
    • LY3502970
  • Drug: Placebo
    Administered orally. ISA specific interventions will be listed in the ISA.

Recruiting Locations

Lucas Research, Inc
Morehead City, North Carolina 28557
Contact:
252-222-5700

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.