RECRUITINGPhase 3INTERVENTIONAL
A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
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)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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)
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Orforglipron
Administered orally
DRUG
Placebo
Administered orally
Locations (20)
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Ventura, California, United States
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
New Haven, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Velocity Clinical Research
Lafayette, Louisiana, United States
MedPharmics, LLC
Gulfport, Mississippi, United States
Sundance Clinical Research
St Louis, Missouri, United States
Lucas Research, Inc.
Morehead City, North Carolina, United States
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Houston, Texas, United States
La Providence Pediatrics Clinic - Chemidox Clinical Trials
Houston, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
Velocity Clinical Research, Salt Lake City
South Jordan, Utah, United States
Shamir Medical Center
Beer Jacob, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Sheba Medical Center
Ramat Gan, Israel
Azienda Ospedaliero Universitaria Meyer
Florence, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Italy