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

Last updated: June 17, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Prevention

Obesity

Hypertriglyceridemia

Treatment

Orforglipron

Placebo

Clinical Study ID

NCT06672939
18868
J4M-MC-PW01
2024-514081-40-00
J4M-MC-PWMP Master Protocol
  • Ages 12-17
  • All Genders

Study Summary

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.

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

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Orforglipron
Phase: 3
Study Start date:
November 18, 2024
Estimated Completion Date:
January 31, 2031

Connect with a study center

  • Shamir Medical Center

    Beer Jacob, 73100
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9013102
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Meyer

    Florence, 50139
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

    Verona, 37126
    Italy

    Active - Recruiting

  • Saitama Medical University Hospital

    Iruma-Gun, 350-0495
    Japan

    Active - Recruiting

  • Isesaki Municipal Hospital

    Isesaki-shi, 372-0817
    Japan

    Active - Recruiting

  • University Hospital,Kyoto Prefectural University of Medicine

    Kawaramachidori, Kamigyo-ku, Kyoto-city, 602-8566
    Japan

    Site Not Available

  • Tokyo Medical Center

    Meguro-Ku, 152-0021
    Japan

    Site Not Available

  • Shiga General Hospital

    Moriyama, 524-8524
    Japan

    Active - Recruiting

  • Nara Prefecture General Medical Center

    Nara, 630-8054
    Japan

    Active - Recruiting

  • Osaka City General Hospital

    Osaka, 534-0021
    Japan

    Active - Recruiting

  • Sagaekiminami Clinic

    Saga, 840-0801
    Japan

    Active - Recruiting

  • Shikoku Medical Center for Children and Adults

    Zentsujichó, 765-8507
    Japan

    Active - Recruiting

  • Krakowskie Centrum Medyczne - FutureMeds

    Krakow, 31-501
    Poland

    Active - Recruiting

  • FutureMeds - Targowek

    Warsaw, 03-291
    Poland

    Active - Recruiting

  • Instytut Diabetologii - Warsaw

    Warszewo, 2117
    Poland

    Active - Recruiting

  • FutureMeds sp. z o. o.

    Wroclaw, 53-673
    Poland

    Site Not Available

  • Barnsley Hospital NHS Foundation Trust

    Barnsley, S75 2EP
    United Kingdom

    Active - Recruiting

  • Bristol Royal Hospital for Children

    Bristol, BS2 8BJ
    United Kingdom

    Site Not Available

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Ninewells Hospital

    Dundee, DD1 9SY
    United Kingdom

    Active - Recruiting

  • Northwick Park Hospital

    Harrow, HA1 3UJ
    United Kingdom

    Active - Recruiting

  • Hull Royal Infirmary

    Hull, HU3 2JZ
    United Kingdom

    Active - Recruiting

  • Alder Hey Children's Hospital

    Liverpool, L13 0BH
    United Kingdom

    Site Not Available

  • Carey Chronis MD Pediatric, Infant and Adolescent Medicine

    Ventura, California 93003-5369
    United States

    Site Not Available

  • Stamford Therapeutics Consortium

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Velocity Clinical Research

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • MedPharmics, LLC

    Gulfport, Mississippi 39503-2637
    United States

    Active - Recruiting

  • Sundance Clinical Research

    St Louis, Missouri 63141-7068
    United States

    Site Not Available

  • Lucas Research, Inc.

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Childrens Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Vanderbilt Health One Hundred Oaks

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Dynamed Clinical Research, LP d/b/a DM Clinical Research

    Houston, Texas 77065
    United States

    Site Not Available

  • La Providence Pediatrics Clinic - Chemidox Clinical Trials

    Houston, Texas 77071-1008
    United States

    Site Not Available

  • Martin Diagnostic Clinic

    Tomball, Texas 77375-3332
    United States

    Site Not Available

  • Dynamed Clinical Research, LP d/b/a DM Clinical Research

    Houston 4699066, Texas 4736286 77065
    United States

    Active - Recruiting

  • Velocity Clinical Research, Salt Lake City

    South Jordan, Utah 84088
    United States

    Active - Recruiting

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