Status:
RECRUITING
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Obesity
Overweight
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
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 obesi...
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 testin...
Eligibility Criteria
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.
Key Trial Info
Start Date :
November 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06672549
Start Date
November 18 2024
End Date
March 1 2027
Last Update
March 24 2026
Active Locations (41)
Enter a location and click search to find clinical trials sorted by distance.
1
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Ventura, California, United States, 93003-5369
2
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
New Haven, Connecticut, United States, 06519
3
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
4
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, United States, 30329