Actively Recruiting

Phase 3
Age: 12Years - 17Years
All Genders
NCT06672939

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

Led by Eli Lilly and Company · Updated on 2025-11-05

125

Participants Needed

37

Research Sites

119 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of at least one unsuccessful effort to lose sufficient body weight after at least 3 months of diet and exercise counseling
  • Obesity defined as BMI at or above the 95th percentile for age and sex according to CDC-NCHS 2022 growth charts
  • OR overweight defined as BMI between the 85th and 95th percentile for age and sex with at least one weight-related comorbidity including hypertension, type 2 diabetes, prediabetes, dyslipidemia, obstructive sleep apnea, metabolic dysfunction-associated steatohepatitis (MASH), or metabolic dysfunction-associated steatotic liver disease (MASLD)
Not Eligible

You will not qualify if you...

  • Prepubertal stage (Tanner stage 1)
  • Weight loss greater than 5 kilograms (11 pounds) within 90 days before screening
  • Undergoing or planning weight reduction surgery such as gastric bypass, sleeve gastrectomy, Lap-Band gastric banding, or other weight reduction procedures
  • Diagnosis or history of secondary causes of obesity including hypothalamic, monogenetic, syndromic, or endocrine causes
  • Type 1 diabetes or history of ketoacidosis or hyperosmolar state
  • HbA1c above 9.0% as measured at screening
  • Family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 37 locations

1

Carey Chronis MD Pediatric, Infant and Adolescent Medicine

Ventura, California, United States, 93003-5369

Actively Recruiting

2

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

New Haven, Connecticut, United States, 06519

Not Yet Recruiting

3

Stamford Therapeutics Consortium

Stamford, Connecticut, United States, 06905

Actively Recruiting

4

Children's Healthcare of Atlanta - Center for Advanced Pediatrics

Atlanta, Georgia, United States, 30329

Actively Recruiting

5

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

Chicago, Illinois, United States, 60611

Actively Recruiting

6

Velocity Clinical Research

Lafayette, Louisiana, United States, 70508

Actively Recruiting

7

MedPharmics, LLC

Gulfport, Mississippi, United States, 39503-2637

Actively Recruiting

8

Sundance Clinical Research

St Louis, Missouri, United States, 63141-7068

Actively Recruiting

9

Lucas Research, Inc.

Morehead City, North Carolina, United States, 28557

Actively Recruiting

10

Childrens Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

11

Vanderbilt Health One Hundred Oaks

Nashville, Tennessee, United States, 37204

Not Yet Recruiting

12

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

Houston, Texas, United States, 77065

Actively Recruiting

13

La Providence Pediatrics Clinic - Chemidox Clinical Trials

Houston, Texas, United States, 77071-1008

Actively Recruiting

14

Martin Diagnostic Clinic

Tomball, Texas, United States, 77375-3332

Actively Recruiting

15

Velocity Clinical Research, Salt Lake City

South Jordan, Utah, United States, 84088

Actively Recruiting

16

Shamir Medical Center

Beer Jacob, Israel, 73100

Actively Recruiting

17

Shaare Zedek Medical Center

Jerusalem, Israel, 9013102

Actively Recruiting

18

Sheba Medical Center

Ramat Gan, Israel, 52621

Actively Recruiting

19

Azienda Ospedaliero Universitaria Meyer

Florence, Italy, 50139

Actively Recruiting

20

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, Italy, 28100

Actively Recruiting

21

Ospedale Pediatrico Bambino Gesù

Roma, Italy, 165

Not Yet Recruiting

22

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

Verona, Italy, 37126

Actively Recruiting

23

Saitama Medical University Hospital

Iruma-Gun, Japan, 350-0495

Actively Recruiting

24

Osaka City General Hospital

Osaka, Japan, 534-0021

Actively Recruiting

25

Sagaekiminami Clinic

Saga, Japan, 840-0801

Actively Recruiting

26

Shikoku Medical Center for Children and Adults

Zentsujichó, Japan, 765-8507

Actively Recruiting

27

Krakowskie Centrum Medyczne - FutureMeds

Krakow, Poland, 31-501

Actively Recruiting

28

FutureMeds - Targowek

Warsaw, Poland, 03-291

Actively Recruiting

29

Instytut Diabetologii - Warsaw

Warszewo, Poland, 2117

Actively Recruiting

30

FutureMeds sp. z o. o.

Wroclaw, Poland, 53-673

Active, Not Recruiting

31

Barnsley Hospital NHS Foundation Trust

Barnsley, United Kingdom, S75 2EP

Actively Recruiting

32

Bristol Royal Hospital for Children

Bristol, United Kingdom, BS2 8BJ

Not Yet Recruiting

33

Addenbrookes Hospital

Cambridge, United Kingdom, CB2 0QQ

Actively Recruiting

34

Ninewells Hospital

Dundee, United Kingdom, DD1 9SY

Actively Recruiting

35

Northwick Park Hospital

Harrow, United Kingdom, HA1 3UJ

Actively Recruiting

36

Hull Royal Infirmary

Hull, United Kingdom, HU3 2JZ

Actively Recruiting

37

Alder Hey Children's Hospital

Liverpool, United Kingdom, L13 0BH

Not Yet Recruiting

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Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

P

Physicians interested in becoming principal investigators please contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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