A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
Recruiting · NCT06672939 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
OrforglipronPlacebo
What this trial is about
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.
Who can take part
Age range
12 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
34 locations listed across 10 US states.
- 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
- Barnsley Hospital NHS Foundation Trust - Barnsley, United Kingdom
- Shamir Medical Center - Beer Jacob, Israel
- Ninewells Hospital - Dundee, United Kingdom
- Azienda Ospedaliero Universitaria Meyer - Florence, Italy
- Hull Royal Infirmary - Hull, United Kingdom
- Saitama Medical University Hospital - Iruma-Gun, Japan
- Isesaki Municipal Hospital - Isesaki-shi, Japan
- Shaare Zedek Medical Center - Jerusalem, Israel
- University Hospital,Kyoto Prefectural University of Medicine - Kawaramachidori, Kamigyo-ku, Kyoto-city, Japan
- Krakowskie Centrum Medyczne - FutureMeds - Krakow, Poland
- Tokyo Medical Center - Meguro-Ku, Japan
- Shiga General Hospital - Moriyama, Japan
- Nara Prefecture General Medical Center - Nara, Japan
- Azienda Ospedaliero Universitaria Maggiore della Carità - Novara, Italy
- Osaka City General Hospital - Osaka, Japan
- Sheba Medical Center - Ramat Gan, Israel
- Sagaekiminami Clinic - Saga, Japan
- Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento - Verona, Italy
- FutureMeds - Targowek - Warsaw, Poland
- Instytut Diabetologii - Warsaw - Warszewo, Poland
- FutureMeds sp. z o. o. - Wroclaw, Poland
- Shikoku Medical Center for Children and Adults - Zentsujichó, Japan