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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT06672939

Registry updated: 2026-08-24
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Description

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.

Interventions

  • Orforglipron (Drug)
    Administered orally
  • Placebo (Drug)
    Administered orally

Eligibility criteria

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.

Conditions

Obesity Overweight

Locations

  • Carey Chronis MD Pediatric, Infant and Adolescent Medicine — Oxnard, California, United States
  • Stamford Therapeutics Consortium — Stamford, Connecticut, United States
  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics — Atlanta, Georgia, United States
  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
  • Velocity Clinical Research — Lafayette, Louisiana, United States
  • Sundance Clinical Research — St Louis, Missouri, United States
  • Lucas Research, Inc. — Morehead City, North Carolina, United States
  • Childrens Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
  • Vanderbilt Health One Hundred Oaks — Nashville, Tennessee, United States
  • Dynamed Clinical Research, LP d/b/a DM Clinical Research — Houston, Texas, United States
  • La Providence Pediatrics Clinic - Chemidox Clinical Trials — Houston, Texas, United States
  • Martin Diagnostic Clinic — Tomball, Texas, United States
  • Shamir Medical Center — Beer Jacob, Israel
  • Shaare Zedek Medical Center — Jerusalem, Israel
  • Sheba Medical Center — Ramat Gan, Israel
  • Azienda Ospedaliero Universitaria Meyer — Florence, Italy
  • Azienda Ospedaliero Universitaria Maggiore della Carità — Novara, Italy
  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento — Verona, Italy
  • Saitama Medical University Hospital — Iruma-Gun, Japan
  • Isesaki Municipal Hospital — Isesaki-shi, Japan
  • University Hospital,Kyoto Prefectural University of Medicine — Kawaramachidori, Kamigyo-ku, Kyoto-city, Japan
  • Tokyo Medical Center — Meguro-Ku, Japan
  • Shiga General Hospital — Moriyama, Japan
  • Nara Prefecture General Medical Center — Nara, Japan
  • Osaka City General Hospital — Osaka, Japan
  • Sagaekiminami Clinic — Saga, Japan
  • Shikoku Medical Center for Children and Adults — Zentsujichó, Japan
  • Krakowskie Centrum Medyczne - FutureMeds — Krakow, Poland
  • FutureMeds - Targowek — Warsaw, Poland
  • Instytut Diabetologii - Warsaw — Warszewo, Poland
  • FutureMeds sp. z o. o. — Wroclaw, Poland
  • Barnsley Hospital NHS Foundation Trust — Barnsley, United Kingdom
  • Ninewells Hospital — Dundee, United Kingdom
  • Hull Royal Infirmary — Hull, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record