A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
This research study, called LY900040, is looking for children and teenagers between 6 and 17 years old who are overweight or have obesity. It's designed to see how safe and effective a new medicine, Orforglipron, is at helping young people manage their weight. Some participants will receive the active medicine, while others will receive a placebo (a dummy medicine with no active ingredients). This type of study, called a 'platform trial', allows researchers to test different treatments over time under one main plan. The goal is to discover new and better ways to support young people in achieving a healthy weight, especially if previous efforts with diet and exercise haven't worked well enough.
At a glance
What is this study about?
This research is a 'platform trial' called LY900040, focusing on children and teenagers aged 6 to 17 who are overweight or have obesity. The main goal is to find out if a new medication, Orforglipron, is a safe and effective way to help young people manage their weight. It's compared against a placebo, which looks like the real medicine but contains no active ingredients. This helps researchers understand if any changes are truly due to the new medicine.
Think of a platform trial as a big umbrella study that can test several different treatments for the same condition over time. This particular trial has specific 'Individual Sub-studies' (called ISAs) that can start independently. This means that as new treatments become available for testing, they can be included efficiently within the existing framework.
The study aims to provide more options for managing weight in young people. Many factors can contribute to obesity, and sometimes diet and exercise alone aren't enough. By researching new medications, scientists hope to develop better tools to help young people achieve and maintain a healthy weight, which can improve their overall health and well-being.
Key takeaways
- This study is for children and teenagers (6-17) with overweight or obesity.
- It tests a new medicine, Orforglipron, against a placebo.
- Aims to find safer and more effective weight management options for young people.
- Participants will have regular clinic visits and take study medication.
- Eligibility includes prior unsuccessful attempts at weight loss with diet/exercise.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, children and teenagers must be between 6 and 17 years old. They need to have tried to lose weight before through a structured diet and exercise plan for at least 3 months, but found it didn't help enough.
For those aged 6 and above, they must have obesity, meaning their Body Mass Index (BMI) is at or above the 95th percentile for their age and sex. For those between 12 and under 18, they can also join if they are overweight (BMI between the 85th and 95th percentile for their age and sex) AND have at least one weight-related health problem. These problems include high blood pressure, type 2 diabetes, prediabetes, high cholesterol, sleep apnoea, or certain liver conditions.
You cannot join if you have had weight-loss surgery or plan to have it during the study. You also cannot join if your obesity is caused by another specific medical condition, like certain hormone problems. If you've recently lost a lot of weight (more than 5 kg or 11 lbs) in the 3 months before the study, or have type 1 diabetes or specific thyroid conditions, you won't be able to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is your child aged between 6 and 17 years old?
- Has your child tried a structured diet and exercise plan for at least 3 months to lose weight, but found it wasn't enough?
- Does your child have obesity (BMI at or above 95th percentile for age/sex)? OR, if 12-17 years old, are they overweight (BMI 85th-95th percentile) AND have a weight-related health issue?
- Has your child NOT had or planned weight-loss surgery?
- Does your child NOT have type 1 diabetes or specific thyroid conditions?
What does participation involve?
If you join this study, you will be assigned to either receive the new medication called Orforglipron or a placebo, which looks identical but has no active ingredients. You won't know which one you're receiving, and neither will the study team, to ensure fair results. The study will involve regular visits to the clinic where you'll have various assessments, such as weight measurements, blood tests, and discussions about your health and how you're feeling. You'll likely need to take the study medicine (or placebo) regularly as instructed. The total duration of your involvement could be quite long, as these types of studies often follow participants for an extended period to assess long-term safety and effectiveness. The full results will only be reported once all parts of the study are complete.
Potential risks and benefits
Locations (50)
- Carey Chronis MD Pediatric, Infant and Adolescent MedicineVerified postcodeVentura, United States· Not yet recruiting
- Yale School of Medicine - Yale Diabetes Center (YDC)) TrialsVerified postcodeNew Haven, United States· Not yet recruiting
- Stamford Therapeutics ConsortiumVerified postcodeStamford, United States· Not yet recruiting
- Children's Healthcare of Atlanta - Center for Advanced PediatricsVerified postcodeAtlanta, United States· Not yet recruiting
- Ann and Robert Lurie Children's Hospital of ChicagoVerified postcodeChicago, United States· Not yet recruiting
- Velocity Clinical ResearchVerified postcodeLafayette, United States· Not yet recruiting
- Dynamed Clinical Research, LP d/b/a DM Clinical ResearchVerified postcodeGulfport, United States· Not yet recruiting
- Sundance Clinical ResearchVerified postcodeSt Louis, United States· Not yet recruiting
- Velocity Clinical ResearchVerified postcodeOmaha, United States· Not yet recruiting
- Lucas Research, IncVerified postcodeMorehead City, United States· Recruiting
- UPMC Children's Hospital of PittsburghVerified postcodePittsburgh, United States· Not yet recruiting
- Vanderbilt Health One Hundred OaksVerified postcodeNashville, United States· Not yet recruiting
Common questions
What is Orforglipron?
Orforglipron is a new medicine being tested to see if it can help children and teenagers manage their weight.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the real thing but doesn't contain any active ingredients. It helps researchers understand if the new medicine is truly making a difference.
How long will the study last?
The study involves regular visits and medication, and the overall trial will run for a significant period. The specific length of time for each participant can vary, and the final results will be available after all parts are complete.
Will I or my child know if we are getting the real medicine or the placebo?
No, neither you, your child, nor the study team will know who is receiving the active medication and who is receiving the placebo. This is a common practice in research called 'blinding' to ensure fair and unbiased results.
What if we change our mind about participating?
Joining the study is completely voluntary. You can decide to withdraw yourself or your child from the study at any time, for any reason, without it affecting your medical care.
How to find out more
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.