A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities

August 21, 2026 updated by: Eli Lilly and Company

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Israel
      • Beer Jacob, Israel, 73100
        • Active, not recruiting
        • Shamir Medical Center
      • Jerusalem, Israel, 9013102
        • Active, not recruiting
        • Shaare Zedek Medical Center
      • Ramat Gan, Israel, 52621
        • Active, not recruiting
        • Sheba Medical Center
  • Italy
      • Florence, Italy, 50139
        • Active, not recruiting
        • Azienda Ospedaliero Universitaria Meyer
      • Novara, Italy, 28100
        • Active, not recruiting
        • Azienda Ospedaliero Universitaria Maggiore della Carità
      • Verona, Italy, 37126
        • Active, not recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
  • Japan
      • Iruma-Gun, Japan, 350-0495
        • Recruiting
        • Saitama Medical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Toru Kikuchi
      • Isesaki-shi, Japan, 372-0817
        • Recruiting
        • Isesaki Municipal Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yoko Takano
      • Kawaramachidori, Kamigyo-ku, Kyoto-city, Japan, 602-8566
        • Not yet recruiting
        • University Hospital,Kyoto Prefectural University of Medicine
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Satoru Sugimoto
      • Meguro-Ku, Japan, 152-0021
        • Recruiting
        • Tokyo Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masashi Miharu
      • Moriyama, Japan, 524-8524
        • Recruiting
        • Shiga General Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Katsuyuki Matsui
      • Nara, Japan, 630-8054
        • Recruiting
        • Nara Prefecture General Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Sayaka Yoshida
      • Osaka, Japan, 534-0021
        • Recruiting
        • Osaka City General Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Jun Mori
      • Saga, Japan, 840-0801
        • Recruiting
        • Sagaekiminami Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tateo Kuno
      • Zentsujichó, Japan, 765-8507
        • Recruiting
        • Shikoku Medical Center for Children and Adults
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takafumi Okada
  • Poland
      • Krakow, Poland, 31-501
        • Active, not recruiting
        • Krakowskie Centrum Medyczne - FutureMeds
      • Warsaw, Poland, 03-291
        • Active, not recruiting
        • FutureMeds - Targowek
      • Warszewo, Poland, 2117
        • Active, not recruiting
        • Instytut Diabetologii - Warsaw
      • Wroclaw, Poland, 53-673
        • Active, not recruiting
        • FutureMeds sp. z o. o.
  • United Kingdom
      • Barnsley, United Kingdom, S75 2EP
        • Active, not recruiting
        • Barnsley Hospital NHS Foundation Trust
      • Dundee, United Kingdom, DD1 9SY
        • Not yet recruiting
        • Ninewells Hospital
        • Principal Investigator:
          • Nicholas Conway
        • Contact:
          • Phone Number: (44138) 238-8385
      • Hull, United Kingdom, HU3 2JZ
        • Active, not recruiting
        • Hull Royal Infirmary
  • United States
    • California
      • Oxnard, California, United States, 93030
        • Active, not recruiting
        • Carey Chronis MD Pediatric, Infant and Adolescent Medicine
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Active, not recruiting
        • Stamford Therapeutics Consortium
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Active, not recruiting
        • Children's Healthcare of Atlanta - Center for Advanced Pediatrics
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Active, not recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Active, not recruiting
        • Velocity Clinical Research
    • Missouri
      • St Louis, Missouri, United States, 63141-7068
        • Active, not recruiting
        • Sundance Clinical Research
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Active, not recruiting
        • Lucas Research, Inc.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Active, not recruiting
        • Childrens Hospital of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Active, not recruiting
        • Vanderbilt Health One Hundred Oaks
    • Texas
      • Houston, Texas, United States, 77065
        • Active, not recruiting
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
      • Houston, Texas, United States, 77071-1008
        • Active, not recruiting
        • La Providence Pediatrics Clinic - Chemidox Clinical Trials
      • Tomball, Texas, United States, 77375-3332
        • Active, not recruiting
        • Martin Diagnostic Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo orally
Drug: Placebo
Administered orally
Experimental: Orforglipron
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 72
Baseline, Week 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Body Weight
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Systolic Blood Pressure
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Diastolic Blood Pressure
Time Frame: Baseline, Week 72
Baseline, Week 72
Percent Change from Baseline in Total Cholesterol
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Fasting Glucose
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in BMI
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Body Weight Percentile
Time Frame: Baseline, Week 72
Based on sex- and age-specific growth charts
Baseline, Week 72
Change in Impact of Weight on Quality of Life (IWQOL)-Kids Total and Domain Scores
Time Frame: Baseline, Week 72

The IWQOL-Kids is a validated, 27-item, patient reported outcomes instrument that assesses weight-related quality of life for youth aged 11 to 19 years in 4 domains:

  • physical comfort (6 items)
  • body esteem (9 items)
  • social life (6 items), and
  • family relations (6 items). It has a recall period of "the past 7 days." All items are rated on a 5-point truth scale ("always true" to "never true"). The 4-domain scores and total score range from 0 to 100, with higher scores indicating better quality of life.
Baseline, Week 72
Percent Change from Baseline in Fasting Insulin
Time Frame: Baseline, Week 72
Baseline, Week 72
Percent Change from Baseline in Total Body Fat Mass as Determined by Dual-Energy X-Ray Absorptiometry (DXA)
Time Frame: Baseline, Week 72
Baseline, Week 72
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Orforglipron
Time Frame: Baseline, Week 72
Baseline, Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

November 1, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18868
  • J4M-MC-PW01 (Other Identifier: Eli Lilly and Company)
  • J4M-MC-PWMP Master Protocol (Other Identifier: Eli Lilly and Company)
  • 2024-514081-40-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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