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NCT06672939PHASE3Recruiting

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

Eli Lilly and Company

Start Date

11/18/2024

Completion Date

1/1/2031

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

Age Range: 12 years to 17 years

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.

Interventions

DRUG

Orforglipron

DRUG

Placebo

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Conditions

ObesityOverweight

Locations

Carey Chronis MD Pediatric, Infant and Adolescent Medicine

Ventura, California 93003-5369

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 37212

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

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

Verona, 37126

Italy

Saitama Medical University Hospital

Iruma-Gun, 350-0495

Japan

Isesaki Municipal Hospital

Isesaki-shi, 372-0817

Japan

University Hospital,Kyoto Prefectural University of Medicine

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

Japan

Tokyo Medical Center

Meguro-Ku, 152-0021

Japan

Shiga General Hospital

Moriyama, 524-8524

Japan

Nara Prefecture General Medical Center

Nara, 630-8054

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

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