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RecruitingPhase 3

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a once-daily orforglipron pill against a placebo (a pill with no active drug) in teens with obesity, or overweight with related health problems. It checks how well the drug works, its safety, and how the body handles it over about 18 months. After finishing the main study and safety follow-up, participants may receive 156 more weeks of orforglipron and continue the lifestyle program.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have tried at least one diet and exercise counseling program for at least 3 months before screening but did not lose enough weight.
  • Have obesity: a BMI (a measure based on height and weight) at or above the 95th percentile for age and sex on a growth chart.
  • OR have overweight: a BMI from the 85th to below the 95th percentile for age and sex, plus at least one of these health problems: high blood pressure, type 2 diabetes, prediabetes (blood sugar above normal), unhealthy blood fat levels, sleep apnea (breathing that stops and starts during sleep), or liver disease linked to fat buildup, with or without swelling and damage.

Who can't join

  • Have not started puberty.
  • Have lost more than 11 pounds (5 kilograms) in the 90 days before screening, as reported by you or your parent or guardian.
  • Have had, or plan to have during the study, surgery or another procedure meant to cause weight loss.
  • Have obesity caused by another condition, or sudden weight gain suggesting another cause, such as a hormone, brain, or genetic condition.
  • Have type 1 diabetes or a history of ketoacidosis (dangerous acid buildup in the blood) or a hyperosmolar state (very high blood sugar with severe loss of body water).
  • Have an HbA1c above 9.0% at screening. This blood test measures average blood sugar over time.
  • Have a personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia Syndrome Type 2, a condition that can cause tumors in glands that make hormones.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (12)

CA

CT

GA

IL

LA

MO

NC

PA

TN

TX