A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Obesity, Overweight
In brief
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.
Key facts
- Study ID
- NCT06672939
- Run by
- Eli Lilly and Company
- People needed
- 150
- Starts
- 2024-11-18
- Expected to finish
- 2031-01-01
- Last updated by the study team
- 2026-07-22
Who can join
Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Nara Prefecture General Medical Center — Nara, Japan (enrolling)
- Osaka City General Hospital — Osaka, Japan (enrolling)
- Sagaekiminami Clinic — Saga, Japan (enrolling)
- Shikoku Medical Center for Children and Adults — Zentsujichó, Japan (enrolling)
- Velocity Clinical Research, Salt Lake City — South Jordan, Utah, United States (enrolling)
- Saitama Medical University Hospital — Iruma-Gun, Japan (enrolling)
- Isesaki Municipal Hospital — Isesaki-shi, Japan (enrolling)
- MedPharmics, LLC — Gulfport, Mississippi, United States (enrolling)
- Tokyo Medical Center — Meguro-Ku, Japan (enrolling)
- Addenbrookes Hospital — Cambridge, United Kingdom (enrolling)
- Ninewells Hospital — Dundee, United Kingdom (enrolling)
- Northwick Park Hospital — Harrow, United Kingdom (enrolling)
- Shiga General Hospital — Moriyama, Japan (enrolling)
- 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
- University Hospital,Kyoto Prefectural University of Medicine — Kawaramachidori, Kamigyo-ku, Kyoto-city, 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
- Carey Chronis MD Pediatric, Infant and Adolescent Medicine — Ventura, California, United States
Full record on ClinicalTrials.gov
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