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Orforglipron for Pediatric Obesity (ADVANCE Trial)
Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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])
Must not have
Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Summary
This trial aims to test how safe and effective certain medications are for treating obesity in children.
Who is the study for?
This trial is for children with obesity or overweight issues. Specific details about who can join are not provided, but typically participants must meet certain health criteria and may need parental consent due to their age.
What is being tested?
The study is testing the safety and effectiveness of a drug called Orforglipron compared to a placebo (a substance with no active drug) in managing weight for obese or overweight kids as part of a larger program.
What are the potential side effects?
Potential side effects are not listed, but common ones for weight management drugs can include digestive issues, headaches, increased blood pressure, and fatigue. The exact side effects will depend on the specific medication being tested.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I tried and failed to lose enough weight with a diet and exercise program for 3 months.
Select...
My BMI is in the top 5% for my age and sex.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have type 1 diabetes or have had ketoacidosis or a hyperosmolar state.
Select...
I have had or plan to have surgery to help me lose weight.
Select...
I or my family have a history of medullary thyroid cancer or MEN2.
Select...
My obesity is due to a specific medical condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Orforglipron (ISA PW01)Experimental Treatment2 Interventions
Participants will receive orforglipron or placebo orally. Each ISA will detail the intervention specific.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Orforglipron
2024
Completed Phase 1
~80
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,466,259 Total Patients Enrolled
69 Trials studying Obesity
46,962 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,716 Total Patients Enrolled
52 Trials studying Obesity
25,767 Patients Enrolled for Obesity