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Clinical Trials in the USA / NCT06672939
Recruiting Phase 3

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

NCT06672939 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2024-11-18
Last updated
2026-08-24

Condition(s) studied

ObesityOverweight

Investigational drug(s) / intervention(s)

OrforglipronPlacebo

Orforglipron: Administered orally

Placebo: Administered orally

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
Carey Chronis MD Pediatric, Infant and Adolescent Medicine Oxnard California Active Not Recruiting
Stamford Therapeutics Consortium Stamford Connecticut Active Not Recruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics Atlanta Georgia Active Not Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois Active Not Recruiting
Velocity Clinical Research Lafayette Louisiana Active Not Recruiting
Sundance Clinical Research St Louis Missouri Active Not Recruiting
Lucas Research, Inc. Morehead City North Carolina Active Not Recruiting
Childrens Hospital of Pittsburgh Pittsburgh Pennsylvania Active Not Recruiting
Vanderbilt Health One Hundred Oaks Nashville Tennessee Active Not Recruiting
Dynamed Clinical Research, LP d/b/a DM Clinical Research Houston Texas Active Not Recruiting
La Providence Pediatrics Clinic - Chemidox Clinical Trials Houston Texas Active Not Recruiting
Martin Diagnostic Clinic Tomball Texas Active Not Recruiting
Shamir Medical Center Beer Jacob Israel Active Not Recruiting
Shaare Zedek Medical Center Jerusalem Israel Active Not Recruiting
Sheba Medical Center Ramat Gan Israel Active Not Recruiting
Azienda Ospedaliero Universitaria Meyer Florence Italy Active Not Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità Novara Italy Active Not Recruiting
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento Verona Italy Active Not Recruiting
Saitama Medical University Hospital Iruma-Gun Japan Recruiting
Isesaki Municipal Hospital Isesaki-shi Japan Recruiting
University Hospital,Kyoto Prefectural University of Medicine Kawaramachidori, Kamigyo-ku, Kyoto-city Japan Not Yet Recruiting
Tokyo Medical Center Meguro-Ku Japan Recruiting
Shiga General Hospital Moriyama Japan Recruiting
Nara Prefecture General Medical Center Nara Japan Recruiting
Osaka City General Hospital Osaka Japan Recruiting
Sagaekiminami Clinic Saga Japan Recruiting
Shikoku Medical Center for Children and Adults Zentsujichó Japan Recruiting
Krakowskie Centrum Medyczne - FutureMeds Krakow Poland Active Not Recruiting
FutureMeds - Targowek Warsaw Poland Active Not Recruiting
Instytut Diabetologii - Warsaw Warszewo Poland Active Not Recruiting
FutureMeds sp. z o. o. Wroclaw Poland Active Not Recruiting
Barnsley Hospital NHS Foundation Trust Barnsley United Kingdom Active Not Recruiting
Ninewells Hospital Dundee United Kingdom Not Yet Recruiting
Hull Royal Infirmary Hull United Kingdom Active Not Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06672939 on ClinicalTrials.gov ↗ ← All trials in the USA