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RecruitingPHASE3INTERVENTIONAL

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

This research study is investigating a new oral medication called orforglipron for teenagers aged 12 to 17. The participants either have obesity or are overweight with related health conditions like high blood pressure or prediabetes. The main goals are to see how well orforglipron works compared to a dummy pill (placebo) in helping with weight, how safe it is, and how the body handles the medicine. Taking part in the main study will last about 18 months. Those who complete the initial study might have the chance to continue receiving orforglipron for an extra 156 weeks, alongside ongoing support for a healthy lifestyle.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Eli Lilly and Company
Enrolment target
150
Start
18 Nov 2024
Estimated completion
01 Jan 2031

What is this study about?

This study is about a new medicine called orforglipron, which is given as a tablet once a day. It's being tested in young people aged 12 to 17 who are either living with obesity or are overweight and have other health problems linked to their weight. These health problems might include things like high blood pressure, type 2 diabetes, or issues with cholesterol. The researchers want to find out if this new tablet can help with weight management and if it's safe for teenagers to use.

Some study participants will receive orforglipron, while others will be given a placebo, which looks like the study medicine but doesn't contain any active drug. This is a common way to test new medicines and helps researchers understand if any changes are truly due to the medicine. Everyone in the study will also receive advice on healthy diet and exercise, which is known as lifestyle intervention.

Your participation in the main part of the study would last about 18 months. If you complete this part, there might be an opportunity to continue taking the study medicine for an additional three years (156 weeks), alongside continued lifestyle support. This gives researchers a chance to see the long-term effects of the medicine.

Key takeaways

  • Tests a new once-a-day tablet (orforglipron) for weight management in teenagers.
  • For teens aged 12-17 with obesity or overweight linked to other health conditions.
  • Compares orforglipron to a placebo (dummy pill) to see if it works and is safe.
  • Includes support for healthy eating and exercise.
  • The main study lasts about 18 months, with a possible extension.

Who may be eligible?

To be considered for this study, you would typically be between 12 and 17 years old. You should have previously tried to lose weight for at least three months through a structured diet and exercise plan without enough success.

Your weight would need to meet certain criteria related to obesity or being overweight. If you are overweight, you would also need to have at least one weight-related health condition, such as high blood pressure, prediabetes, or obstructive sleep apnea (where breathing stops and starts during sleep). It's important that your obesity isn't due to another medical condition, like a hormone imbalance.

There are also reasons why you might not be able to join. For example, if you've recently lost a lot of weight (more than 5 kg or 11 pounds) in the last three months, or if you're planning to have weight-loss surgery during the study. If you have Type 1 diabetes, a history of certain thyroid cancers, or very high blood sugar levels, you would also not 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.

  1. Are you between 12 and 17 years old?
  2. Have you tried to lose weight through diet and exercise for at least 3 months recently?
  3. Do you have obesity, or are you overweight with related health conditions?
  4. Have you NOT had a recent significant weight loss (over 5kg/11lbs in 3 months)?
  5. Are you NOT planning any weight-loss surgery or procedures during the study?
Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be involved for about 18 months in the main phase. During this time, you will regularly attend clinic visits (the exact number will be explained by the study team) where various assessments will be done. These might include blood tests, physical examinations, and having your vital signs checked. You will be given either the study medicine (orforglipron) or a placebo to take once daily as a tablet, and you'll receive guidance on healthy eating and exercise.

After completing the main 18-month part, there might be an option to continue treatment with orforglipron for another 156 weeks (about three years), still receiving lifestyle advice. Throughout your participation, the study team will monitor your health closely. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Potential risks and benefits

Taking part in this study could offer several potential benefits. You might have access to a new experimental medication that could help with weight management, along with professional support for a healthy lifestyle. You'll also receive careful medical monitoring throughout the study. However, as with any medication, there could be potential risks and side effects from orforglipron, which will be fully explained to you before you decide to participate. The placebo also has no active medicine. You will be closely monitored for any issues that arise. It's important to remember that joining a study is always your choice, and you have the right to leave the study at any time, for any reason, without this affecting your future medical care.

Locations (40)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Carey Chronis MD Pediatric, Infant and Adolescent Medicine
    Verified postcode
    Ventura, United States· Recruiting
  • Stamford Therapeutics Consortium
    Verified postcode
    Stamford, United States· Recruiting
  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics
    Verified postcode
    Atlanta, United States· Recruiting
  • Ann & Robert H. Lurie Children's Hospital of Chicago
    Verified postcode
    Chicago, United States· Recruiting
  • Velocity Clinical Research
    Verified postcode
    Lafayette, United States· Recruiting
  • MedPharmics, LLC
    Verified postcode
    Gulfport, United States· Recruiting
  • Sundance Clinical Research
    Verified postcode
    St Louis, United States· Recruiting
  • Lucas Research, Inc.
    Verified postcode
    Morehead City, United States· Recruiting
  • Childrens Hospital of Pittsburgh
    Verified postcode
    Pittsburgh, United States· Recruiting
  • Vanderbilt Health One Hundred Oaks
    Verified postcode
    Nashville, United States· Recruiting
  • Dynamed Clinical Research, LP d/b/a DM Clinical Research
    Verified postcode
    Houston, United States· Recruiting
  • La Providence Pediatrics Clinic - Chemidox Clinical Trials
    Verified postcode
    Houston, United States· Recruiting

Common questions

What is orforglipron?

Orforglipron is a new medicine being tested as a once-daily tablet that aims to help with weight management.

Who can join this study?

Teenagers aged 12 to 17 with obesity or who are overweight with certain health conditions, and who have tried to lose weight before, might be eligible.

How long does the study last?

The main part of the study is about 18 months. Some participants may have the option to continue for another 156 weeks (around three years).

Will I definitely get the new medicine?

No, you might receive orforglipron or a placebo (a dummy pill with no active medicine). This helps researchers compare the effects fairly.

Can I leave the study at any time?

Yes, you are completely free to leave the study at any point, and doing so will not affect your regular 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?

Register your interest

Share your details and the research team for "A Study of Orforglipron (LY3502970) in Adolescent Participan…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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