A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
NCT ID: NCT06672939
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
125 participants
INTERVENTIONAL
2024-11-18
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Orforglipron
Participants will receive orforglipron orally
Orforglipron
Administered orally
Placebo
Participants will receive placebo orally
Placebo
Administered orally
Interventions
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Orforglipron
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
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Role: CONTACT
Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Related Links
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A Study of Orforglipron (LY3502970) in Adolescent Participants with Obesity, or Overweight with Related Comorbidities
Other Identifiers
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J4M-MC-PW01
Identifier Type: OTHER
Identifier Source: secondary_id
J4M-MC-PWMP Master Protocol
Identifier Type: OTHER
Identifier Source: secondary_id
2024-514081-40-00
Identifier Type: CTIS
Identifier Source: secondary_id
18868
Identifier Type: -
Identifier Source: org_study_id
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