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A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
Sponsor: Eli Lilly and Company
Summary
The main purpose of this study, performed under Master Protocol J4M-MC-PWMP, 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.
Official title: Efficacy, Safety, and Pharmacokinetics of Orforglipron Once Daily Oral Versus Placebo in Adolescent Participants Who Have Obesity, or Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (ADVANCE-ATTAIN-ADOLESCENTS)
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
125
Start Date
2024-11-18
Completion Date
2027-03
Last Updated
2025-11-05
Healthy Volunteers
No
Conditions
Interventions
Orforglipron
Administered orally
Placebo
Administered orally
Locations (37)
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Ventura, California, United States
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
New Haven, Connecticut, 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
MedPharmics, LLC
Gulfport, Mississippi, 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
Velocity Clinical Research, Salt Lake City
South Jordan, Utah, 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
Ospedale Pediatrico Bambino Gesù
Roma, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, Italy
Saitama Medical University Hospital
Iruma-Gun, 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
Bristol Royal Hospital for Children
Bristol, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Northwick Park Hospital
Harrow, United Kingdom
Hull Royal Infirmary
Hull, United Kingdom
Alder Hey Children's Hospital
Liverpool, United Kingdom