A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
Start Date
11/18/2024
Completion Date
1/1/2031
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 Criteria
Age Range: 12 years to 17 years
Interventions
Orforglipron
Placebo
Conditions
Locations
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Ventura, California 93003-5369
United States
Stamford Therapeutics Consortium
Stamford, Connecticut 06905
United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia 30329
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United States
Velocity Clinical Research
Lafayette, Louisiana 70508
United States
MedPharmics, LLC
Gulfport, Mississippi 39503-2637
United States
Sundance Clinical Research
St Louis, Missouri 63141-7068
United States
Lucas Research, Inc.
Morehead City, North Carolina 28557
United States
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
United States
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee 37212
United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Houston, Texas 77065
United States
La Providence Pediatrics Clinic - Chemidox Clinical Trials
Houston, Texas 77071-1008
United States
Martin Diagnostic Clinic
Tomball, Texas 77375-3332
United States
Velocity Clinical Research, Salt Lake City
South Jordan, Utah 84088
United States
Shamir Medical Center
Beer Jacob, 73100
Israel
Shaare Zedek Medical Center
Jerusalem, 9013102
Israel
Sheba Medical Center
Ramat Gan, 52621
Israel
Azienda Ospedaliero Universitaria Meyer
Florence, 50139
Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, 37126
Italy
Saitama Medical University Hospital
Iruma-Gun, 350-0495
Japan
Isesaki Municipal Hospital
Isesaki-shi, 372-0817
Japan
University Hospital,Kyoto Prefectural University of Medicine
Kawaramachidori, Kamigyo-ku, Kyoto-city, 602-8566
Japan
Tokyo Medical Center
Meguro-Ku, 152-0021
Japan
Shiga General Hospital
Moriyama, 524-8524
Japan
Nara Prefecture General Medical Center
Nara, 630-8054
Japan
Osaka City General Hospital
Osaka, 534-0021
Japan
Sagaekiminami Clinic
Saga, 840-0801
Japan
Shikoku Medical Center for Children and Adults
Zentsujichó, 765-8507
Japan
Krakowskie Centrum Medyczne - FutureMeds
Krakow, 31-501
Poland
FutureMeds - Targowek
Warsaw, 03-291
Poland
Instytut Diabetologii - Warsaw
Warszewo, 2117
Poland
FutureMeds sp. z o. o.
Wroclaw, 53-673
Poland
Barnsley Hospital NHS Foundation Trust
Barnsley, S75 2EP
United Kingdom
Addenbrookes Hospital
Cambridge, CB2 0QQ
United Kingdom
Ninewells Hospital
Dundee, DD1 9SY
United Kingdom
Northwick Park Hospital
Harrow, HA1 3UJ
United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ
United Kingdom