Orforglipron for Pediatric Obesity

(ADVANCE Trial)

Recruiting in Palo Alto (17 mi)

+46 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Eli Lilly and Company

Disqualifiers: Weight reduction surgery, Type 1 diabetes, Thyroid carcinoma, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Orforglipron for pediatric obesity?

Research shows that Orforglipron, a drug similar to other GLP-1 receptor agonists, has been effective in helping adults with obesity lose weight. This suggests it might also help children with obesity, as similar drugs have shown positive effects in children. ^{1 2 3 4 5}

Is orforglipron safe for humans?

Orforglipron has been studied for safety in people with type 2 diabetes and obesity, showing it is generally safe for these conditions. However, specific safety data for pediatric obesity is not available from the studies mentioned. ^{2 3 4 5 6}

How is the drug orforglipron different from other treatments for pediatric obesity?

Orforglipron is unique because it is an oral, non-peptide drug that targets the GLP-1 receptor, which is different from many other obesity treatments that are injectable. This makes it potentially more convenient for children and adolescents who may prefer taking a pill over injections. ^{1 2 3 4 5}

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

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.

Inclusion Criteria

I am a teenager who is overweight with a health issue like high blood pressure or type 2 diabetes.

My BMI is in the top 5% for my age and sex.

I tried and failed to lose enough weight with a diet and exercise program for 3 months.

Exclusion Criteria

I have type 1 diabetes or have had ketoacidosis or a hyperosmolar state.

Have HbA1c >9.0% (75 mmol/mol) as measured by central laboratory at screening

I or my family have a history of medullary thyroid cancer or MEN2.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orforglipron or placebo orally for chronic weight management

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Orforglipron (Other)

Trial Overview 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.

Participant Groups

Group I: Orforglipron (ISA PW01) Experimental Treatment 2 Interventions

Participants will receive orforglipron or placebo orally. Each ISA will detail the intervention specific.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MedPharmics, LLC Gulfport, MS

Stamford Therapeutics Consortium Stamford, CT

Ann and Robert Lurie Children's Hospital of Chicago Chicago, IL

Velocity Clinical Research Lafayette, LA

More Trial Locations

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2708

Patients Recruited

3,720,000+

Findings from Research

In a 26-week phase 2 trial involving 383 participants with type 2 diabetes, orforglipron significantly reduced HbA1c levels by up to -2.10% compared to placebo and showed greater weight loss of up to -10.1 kg, indicating its efficacy as a treatment option.

The safety profile of orforglipron was comparable to other GLP-1 receptor agonists, with most adverse events being mild to moderate gastrointestinal issues, suggesting it may be a safer and more convenient alternative to injectable treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. Frias, JP., Hsia, S., Eyde, S., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Glucagon-Like Peptide-1 Receptor Agonists in Children and Adolescents with Obesity: A Meta-Analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Orforglipron (LY3502970), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist: A Phase 1b, multicentre, blinded, placebo-controlled, randomized, multiple-ascending-dose study in people with type 2 diabetes. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

In obesity or overweight without diabetes, orforglipron increased weight loss at 26 wk. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. [2023]

6. England pubmed.ncbi.nlm.nih.gov

LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial. [2022]