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Evaluating Orforglipron for Adolescents with Obesity or Overweight

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)

PHASE3 · Eli Lilly and Company · NCT06672939

This study is testing if an oral medication called orforglipron can help adolescents who are overweight or obese improve their weight and health over 18 months.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment125 (estimated)
Ages12 Years to 17 Years
SexAll
SponsorEli Lilly and Company (industry)
Locations37 sites (Ventura, California and 36 other locations)
Trial IDNCT06672939 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, and pharmacokinetics of orforglipron, an oral medication, compared to a placebo in adolescents who are obese or overweight with related health issues. Participants will engage in the study for approximately 18 months, during which their weight and health outcomes will be closely monitored. The study is designed to provide insights into how well orforglipron can help manage weight and associated comorbidities in this population.

Who should consider this trial

Good fit: Ideal candidates include adolescents with obesity or overweight who have previously attempted weight loss through structured lifestyle modifications but have not achieved sufficient results.

Not a fit: Patients who are prepubertal or do not have a history of unsuccessful weight loss efforts may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve weight management and health outcomes for adolescents struggling with obesity and related conditions.

How similar studies have performed: Other studies have shown promise in using similar pharmacological approaches for weight management in adolescents, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Ventura, California and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Obesity, Overweight

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.