Phase
Condition
Diabetes Prevention
Obesity
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
Shamir Medical Center
Beer Jacob, 73100
IsraelActive - Recruiting
Shaare Zedek Medical Center
Jerusalem, 9013102
IsraelActive - Recruiting
Sheba Medical Center
Ramat Gan, 52621
IsraelActive - Recruiting
Azienda Ospedaliero Universitaria Meyer
Florence, 50139
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, 37126
ItalyActive - Recruiting
Saitama Medical University Hospital
Iruma-Gun, 350-0495
JapanActive - Recruiting
Isesaki Municipal Hospital
Isesaki-shi, 372-0817
JapanActive - Recruiting
University Hospital,Kyoto Prefectural University of Medicine
Kawaramachidori, Kamigyo-ku, Kyoto-city, 602-8566
JapanSite Not Available
Tokyo Medical Center
Meguro-Ku, 152-0021
JapanSite Not Available
Shiga General Hospital
Moriyama, 524-8524
JapanActive - Recruiting
Nara Prefecture General Medical Center
Nara, 630-8054
JapanActive - Recruiting
Osaka City General Hospital
Osaka, 534-0021
JapanActive - Recruiting
Sagaekiminami Clinic
Saga, 840-0801
JapanActive - Recruiting
Shikoku Medical Center for Children and Adults
Zentsujichó, 765-8507
JapanActive - Recruiting
Krakowskie Centrum Medyczne - FutureMeds
Krakow, 31-501
PolandActive - Recruiting
FutureMeds - Targowek
Warsaw, 03-291
PolandActive - Recruiting
Instytut Diabetologii - Warsaw
Warszewo, 2117
PolandActive - Recruiting
FutureMeds sp. z o. o.
Wroclaw, 53-673
PolandSite Not Available
Barnsley Hospital NHS Foundation Trust
Barnsley, S75 2EP
United KingdomActive - Recruiting
Bristol Royal Hospital for Children
Bristol, BS2 8BJ
United KingdomSite Not Available
Addenbrookes Hospital
Cambridge, CB2 0QQ
United KingdomActive - Recruiting
Ninewells Hospital
Dundee, DD1 9SY
United KingdomActive - Recruiting
Northwick Park Hospital
Harrow, HA1 3UJ
United KingdomActive - Recruiting
Hull Royal Infirmary
Hull, HU3 2JZ
United KingdomActive - Recruiting
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
Stamford Therapeutics Consortium
Stamford, Connecticut 06905
United StatesSite Not Available
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
St Louis, Missouri 63141-7068
United StatesSite Not Available
Lucas Research, Inc.
Morehead City, North Carolina 28557
United StatesSite Not Available
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee 37212
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
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Houston 4699066, Texas 4736286 77065
United StatesActive - Recruiting
Velocity Clinical Research, Salt Lake City
South Jordan, Utah 84088
United StatesActive - Recruiting

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