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A Study of Orforglipron for Adolescent Obesity or Overweight

This study is testing a medicine called Orforglipron, given by mouth, for teenagers aged 12 to 17 who have obesity or are overweight with other health problems. We want to see how well Orforglipron works compared to a placebo (a pill with no medicine) to help with weight loss, and if it's safe. We'll also look at how the body handles the medicine. To join, you must have tried to lose weight before through diet and exercise for at least 3 months, and meet specific body mass index (BMI) requirements for your age and sex. The main goal is to see the change in your BMI after about 18 months. If you complete this study, you might have the chance to continue treatment for an additional 156 weeks.

Study design
This is an interventional study comparing Orforglipron to a placebo, planning to enroll 150 participants. The study is part of a larger master protocol.
What's involved
Participation in the study will last about 18 months. If you complete the initial study, you may have the option for an additional 156 weeks of treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, change in BMI, is measured at Week 72. Participants completing the initial study may have the opportunity for an additional 156 weeks of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06672939

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

Recruiting
PHASE3Ages 12–17InterventionalTreatment
Eli Lilly and Company
~150 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:OrforglipronPlacebo

At a glance

Recruiting sites
8 of 34 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Change from Baseline in Body Mass Index (BMI)
Measured over Baseline, Week 72

Conditions

Obesity
Overweight

Explore related trials

ObesityOverweight

Where it's being run

34 sites across 15 states
Japan9
Poland4
Texas3
Israel3
Italy3
United Kingdom3
California1
Connecticut1

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percent Change from Baseline in Body Mass Index (BMI)Baseline, Week 72