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

Last updated: February 26, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Obesity

Diabetes Prevention

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, 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.

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: 125
Treatment Group(s): 2
Primary Treatment: Orforglipron
Phase: 3
Study Start date:
November 18, 2024
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • L2IP - Instituto de Pesquisas Clínicas

    Brasília, Distrito Federal 70200730
    Brazil

    Site Not Available

  • Hospital Universitario de Caxias do Sul

    Caxias do Sul, Rio Grande Do Sul 95070-560
    Brazil

    Site Not Available

  • CPQuali Pesquisa Clínica

    Sao Paulo, 01228-000
    Brazil

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, HaMerkaz 52621
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, Yerushalayim 9013102
    Israel

    Site Not Available

  • Shamir Medical Center

    Beer Jacob, 73100
    Israel

    Site Not Available

  • Azienda Ospedaliero Universitaria Meyer

    Firenze, Toscana 50139
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

    Verona, Veneto 37126
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesù

    Roma, 165
    Italy

    Site Not Available

  • Shikoku Medical Center for Children and Adults

    Zentsuji, Kagawa 765-8507
    Japan

    Active - Recruiting

  • Saitama Medical University Hospital

    Iruma-Gun, Saitama 350-0495
    Japan

    Site Not Available

  • Osaka City General Hospital

    Osaka, 534-0021
    Japan

    Active - Recruiting

  • Sagaekiminami Clinic

    Saga-shi, 840-0801
    Japan

    Site Not Available

  • PanAmerican Clinical Research S.A.de C.V. Guadalajara

    Guadalajara, JA 44670
    Mexico

    Site Not Available

  • Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC

    Culiacan, 80000
    Mexico

    Site Not Available

  • Innovacion y Desarrollo de Estrategias en Salud SA de CV

    Mexico City, 14090
    Mexico

    Site Not Available

  • Hospital Angeles Puebla

    Puebla, 72190
    Mexico

    Site Not Available

  • Krakowskie Centrum Medyczne - FutureMeds

    Kraków, 31-501
    Poland

    Site Not Available

  • Instytut Diabetologii - Warsaw

    Warsow, 2117
    Poland

    Site Not Available

  • FutureMeds - Targowek

    Warszawa, 03-291
    Poland

    Site Not Available

  • FutureMeds sp. z o. o.

    Wroclaw, 53-673
    Poland

    Site Not Available

  • Bristol Royal Hospital for Children

    Bristol, Bristol, City Of BS2 8BJ
    United Kingdom

    Site Not Available

  • Addenbrookes Hospital

    Cambridge, Cambridgeshire CB2 0QQ
    United Kingdom

    Site Not Available

  • Hull Royal Infirmary

    Hull, East Riding Of Yorkshire HU3 2JZ
    United Kingdom

    Site Not Available

  • Northwick Park Hospital

    Harrow, Middlesex HA1 3UJ
    United Kingdom

    Site Not Available

  • Ninewells Hospital

    Dundee, Scotland DD1 9SY
    United Kingdom

    Site Not Available

  • Barnsley Hospital NHS Foundation Trust

    Barnsley, S75 2EP
    United Kingdom

    Site Not Available

  • 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

  • Yale School of Medicine - Yale Diabetes Center (YDC)) Trials

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Stamford Therapeutics Consortium

    Stamford, Connecticut 06905
    United States

    Active - Recruiting

  • 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

    Saint Louis, Missouri 63141-7068
    United States

    Site Not Available

  • Velocity Clinical Research

    Omaha, Nebraska 68134
    United States

    Active - Recruiting

  • Lucas Research, Inc.

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Childrens Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Vanderbilt Health One Hundred Oaks

    Nashville, Tennessee 37204
    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

  • Velocity Clinical Research, Salt Lake City

    South Jordan, Utah 84088
    United States

    Site Not Available

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