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

Description

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

Obesity, Overweight

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Ventura

Carey Chronis MD Pediatric, Infant and Adolescent Medicine, Ventura, California, United States, 93003-5369

New Haven

Yale School of Medicine - Yale Diabetes Center (YDC)) Trials, New Haven, Connecticut, United States, 06519

Stamford

Stamford Therapeutics Consortium, Stamford, Connecticut, United States, 06905

Atlanta

Children's Healthcare of Atlanta - Center for Advanced Pediatrics, Atlanta, Georgia, United States, 30329

Chicago

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611

Lafayette

Velocity Clinical Research, Lafayette, Louisiana, United States, 70508

Gulfport

MedPharmics, LLC, Gulfport, Mississippi, United States, 39503-2637

Saint Louis

Sundance Clinical Research, Saint Louis, Missouri, United States, 63141-7068

Omaha

Velocity Clinical Research, Omaha, Nebraska, United States, 68134

Morehead City

Lucas Research, Inc., Morehead City, North Carolina, United States, 28557

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * 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
  • * 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.

Ages Eligible for Study

12 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2027-03