A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
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)
4 other identifiers
interventional
125
6 countries
37
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 obesity
Started Nov 2024
Typical duration for phase_3 obesity
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2024
CompletedFirst Posted
Study publicly available on registry
November 4, 2024
CompletedStudy Start
First participant enrolled
November 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
November 5, 2025
November 1, 2025
2.2 years
November 1, 2024
November 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change from Baseline in Body Mass Index (BMI)
Baseline, Week 72
Secondary Outcomes (12)
Change from Baseline in BMI
Baseline, Week 72
Change from Baseline in Body Weight
Baseline, Week 72
Change from Baseline in Waist Circumference
Baseline, Week 72
Change from Baseline in Body Weight Percentile
Baseline, Week 72
Change in Impact of Weight on Quality of Life (IWQOL)-Kids Total and Domain Scores
Baseline, Week 72
- +7 more secondary outcomes
Study Arms (2)
Orforglipron
EXPERIMENTALParticipants will receive orforglipron orally
Placebo
PLACEBO COMPARATORParticipants will receive placebo orally
Interventions
Eligibility Criteria
You may qualify if:
- J4M-MC-PWMP
- 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)
You may not qualify if:
- J4M-MC-PW01
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Ventura, California, 93003-5369, United States
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
New Haven, Connecticut, 06519, 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, 37204, 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
Ospedale Pediatrico Bambino Gesù
Roma, 165, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, 37126, Italy
Saitama Medical University Hospital
Iruma-Gun, 350-0495, 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
Bristol Royal Hospital for Children
Bristol, BS2 8BJ, 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
Alder Hey Children's Hospital
Liverpool, L13 0BH, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2024
First Posted
November 4, 2024
Study Start
November 18, 2024
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
November 5, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.