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HomeTrials › NCT06672939

Obesity & weight · Phase 3 · Recruiting now

A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities

NCT06672939 · Sponsor: Eli Lilly and Company

What this trial means for you

This study is recruiting now at 14 US sites. It's studying Orforglipron, Placebo for obesity, overweight.

Who can joinAll sexes, 12 Years – 17 Years
Healthy volunteersNo, diagnosis required
What you'd takeOrforglipron, Placebo
Study length~3 years overall
Planned participants150
TypeInterventional (you receive treatment)

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 main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of orforglipron once daily oral versus Placebo in adolescent participants with obesity, or overweight with related comorbidities. Participation in the study will last about 18 months. Participants who have completed the primary PW01 study (including the 4-week safety follow-up period) will have the opportunity to receive an additional 156 weeks of treatment with orforglipron as well as continuing the lifestyle intervention.

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: J4M-MC-PWMP * 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 * 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: J4M-MC-PW01 * Prepubertal (Tanner stage 1) * Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening J4M-MC-PWMP * 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 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 · Active, not recruiting

Connecticut

  • Stamford Therapeutics Consortium, Stamford · Active, not recruiting

Georgia

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics, Atlanta · Active, not recruiting

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago · Active, not recruiting

Louisiana

  • Velocity Clinical Research, Lafayette · Active, not recruiting

Mississippi

  • MedPharmics, LLC, Gulfport · Recruiting now

Missouri

  • Sundance Clinical Research, St Louis · Active, not recruiting

North Carolina

  • Lucas Research, Inc., Morehead City · Active, not recruiting

Pennsylvania

  • Childrens Hospital of Pittsburgh, Pittsburgh · Active, not recruiting

Tennessee

  • Vanderbilt Health One Hundred Oaks, Nashville · Active, not recruiting

Texas

  • Dynamed Clinical Research, LP d/b/a DM Clinical Research, Houston · Active, not recruiting
  • La Providence Pediatrics Clinic - Chemidox Clinical Trials, Houston · Active, not recruiting
  • Martin Diagnostic Clinic, Tomball · Active, not recruiting

Utah

  • Velocity Clinical Research, Salt Lake City, South Jordan · Recruiting now

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently, so always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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