Phase
Condition
Obesity
Diabetes Prevention
Hypertriglyceridemia
Treatment
Orforglipron
Placebo
Clinical Study ID
Ages 12-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
J4M-MC-PWMP
Have a history of at least 1 unsuccessful effort to lose sufficient body weightafter participation in a structured lifestyle modification program (diet andexercise 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 (onage- 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 metabolicdysfunction-associated steatotic liver disease (MASLD)
Exclusion
Exclusion Criteria:
J4M-MC-PW01
Prepubertal (Tanner stage 1)
Have a self-reported, or by parent or legal guardian where applicable, decrease inbody weight greater than 5 kilograms (kg) (11 pounds) within 90 days beforescreening
J4M-MC-PWMP
Have undergone or plan to undergo weight reduction procedure during the study, suchas, 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 abruptonset 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 MultipleEndocrine Neoplasia Syndrome Type 2.
Study Design
Connect with a study center
L2IP - Instituto de Pesquisas Clínicas
Brasília, Distrito Federal 70200730
BrazilSite Not Available
Hospital Universitario de Caxias do Sul
Caxias do Sul, Rio Grande Do Sul 95070-560
BrazilSite Not Available
CPQuali Pesquisa Clínica
Sao Paulo, 01228-000
BrazilSite Not Available
Sheba Medical Center
Ramat Gan, HaMerkaz 52621
IsraelSite Not Available
Shaare Zedek Medical Center
Jerusalem, Yerushalayim 9013102
IsraelSite Not Available
Shamir Medical Center
Beer Jacob, 73100
IsraelSite Not Available
Azienda Ospedaliero Universitaria Meyer
Firenze, Toscana 50139
ItalySite Not Available
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, Veneto 37126
ItalySite Not Available
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
ItalySite Not Available
Ospedale Pediatrico Bambino Gesù
Roma, 165
ItalySite Not Available
Shikoku Medical Center for Children and Adults
Zentsuji, Kagawa 765-8507
JapanActive - Recruiting
Saitama Medical University Hospital
Iruma-Gun, Saitama 350-0495
JapanSite Not Available
Osaka City General Hospital
Osaka, 534-0021
JapanActive - Recruiting
Sagaekiminami Clinic
Saga-shi, 840-0801
JapanSite Not Available
PanAmerican Clinical Research S.A.de C.V. Guadalajara
Guadalajara, JA 44670
MexicoSite Not Available
Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC
Culiacan, 80000
MexicoSite Not Available
Innovacion y Desarrollo de Estrategias en Salud SA de CV
Mexico City, 14090
MexicoSite Not Available
Hospital Angeles Puebla
Puebla, 72190
MexicoSite Not Available
Krakowskie Centrum Medyczne - FutureMeds
Kraków, 31-501
PolandSite Not Available
Instytut Diabetologii - Warsaw
Warsow, 2117
PolandSite Not Available
FutureMeds - Targowek
Warszawa, 03-291
PolandSite Not Available
FutureMeds sp. z o. o.
Wroclaw, 53-673
PolandSite Not Available
Bristol Royal Hospital for Children
Bristol, Bristol, City Of BS2 8BJ
United KingdomSite Not Available
Addenbrookes Hospital
Cambridge, Cambridgeshire CB2 0QQ
United KingdomSite Not Available
Hull Royal Infirmary
Hull, East Riding Of Yorkshire HU3 2JZ
United KingdomSite Not Available
Northwick Park Hospital
Harrow, Middlesex HA1 3UJ
United KingdomSite Not Available
Ninewells Hospital
Dundee, Scotland DD1 9SY
United KingdomSite Not Available
Barnsley Hospital NHS Foundation Trust
Barnsley, S75 2EP
United KingdomSite Not Available
Alder Hey Children's Hospital
Liverpool, L13 0BH
United KingdomSite Not Available
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Ventura, California 93003-5369
United StatesSite Not Available
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
New Haven, Connecticut 06519
United StatesSite Not Available
Stamford Therapeutics Consortium
Stamford, Connecticut 06905
United StatesActive - Recruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia 30329
United StatesSite Not Available
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
Velocity Clinical Research
Lafayette, Louisiana 70508
United StatesSite Not Available
MedPharmics, LLC
Gulfport, Mississippi 39503-2637
United StatesActive - Recruiting
Sundance Clinical Research
Saint Louis, Missouri 63141-7068
United StatesSite Not Available
Velocity Clinical Research
Omaha, Nebraska 68134
United StatesActive - Recruiting
Lucas Research, Inc.
Morehead City, North Carolina 28557
United StatesActive - Recruiting
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee 37204
United StatesSite Not Available
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Houston, Texas 77065
United StatesSite Not Available
La Providence Pediatrics Clinic - Chemidox Clinical Trials
Houston, Texas 77071-1008
United StatesSite Not Available
Martin Diagnostic Clinic
Tomball, Texas 77375-3332
United StatesSite Not Available
Velocity Clinical Research, Salt Lake City
South Jordan, Utah 84088
United StatesSite Not Available
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