What this trial means for you
This study is recruiting now at 16 US sites. It's studying Orforglipron, Placebo for obesity, overweight.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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 sites by state
California
- Carey Chronis MD Pediatric, Infant and Adolescent Medicine — Ventura · Opening soon
Connecticut
- Yale School of Medicine - Yale Diabetes Center (YDC)) Trials — New Haven · Opening soon
- Stamford Therapeutics Consortium — Stamford · Opening soon
Georgia
- Children's Healthcare of Atlanta - Center for Advanced Pediatrics — Atlanta · Opening soon
Illinois
- Ann and Robert Lurie Children's Hospital of Chicago — Chicago · Opening soon
Louisiana
- Velocity Clinical Research — Lafayette · Opening soon
Mississippi
- Dynamed Clinical Research, LP d/b/a DM Clinical Research — Gulfport · Opening soon
Missouri
- Sundance Clinical Research — St Louis · Opening soon
Nebraska
- Velocity Clinical Research — Omaha · Opening soon
North Carolina
- Lucas Research, Inc — Morehead City · Recruiting now
Pennsylvania
- UPMC Children's Hospital of Pittsburgh — Pittsburgh · Opening soon
Tennessee
- Vanderbilt Health One Hundred Oaks — Nashville · Opening soon
Texas
- Dynamed Clinical Research, LP d/b/a DM Clinical Research — Houston · Opening soon
- La Providence Pediatrics Clinic - Chemidox Clinical Trials — Houston · Opening soon
- Martin Diagnostic Clinic — Tomball · Opening soon
Utah
- Velocity Clinical Research, Salt Lake City — West Jordan · Opening soon
View the official record on ClinicalTrials.gov →
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