A Study of EloraTZP in Adult Participants With Obesity Without Type 2 Diabetes
This research study is testing a new combination medicine, EloraTZP, for adults who are living with obesity and do not have type 2 diabetes. The main goal is to find out if EloraTZP is safe and effective at helping people lose weight. Researchers will compare it to two single medicines (eloralintide and tirzepatide) and a dummy treatment, called a placebo. By comparing these, the study aims to understand the best way to help people manage their weight. Taking part would last about two years, and it's a 'Phase 3' study, which means it's one of the final steps before a new medicine could potentially become widely available.
At a glance
What is this study about?
This study is looking into a new way to help adults who are living with obesity. It's focused on a new combination medicine called EloraTZP. The researchers want to see if this new treatment can help people lose weight safely and effectively. They will compare it to two individual medicines, eloralintide and tirzepatide, and also to a 'placebo'. A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. This helps researchers understand if the new treatment works better than nothing at all.
Finding new ways to manage obesity is very important because it can affect your health in many ways. This study is specifically for people who do not have type 2 diabetes, as many weight loss studies often include people with diabetes. By doing this research, scientists hope to find better options for people in the UK and worldwide to improve their health and well-being.
This is a 'Phase 3' study, which is an important step in developing new medicines. It means the treatment has already been tested in smaller groups and is now being looked at in a larger number of people to confirm its benefits and understand any potential side effects before it could be approved for general use.
Key takeaways
- This study is testing a new combination medicine (EloraTZP) for obesity in adults.
- It's for people who do not have type 2 diabetes.
- The study compares EloraTZP with other treatments and a dummy medicine (placebo).
- Participation would last for about two years with regular health check-ups.
- It's a 'Phase 3' study, aiming to find safer and more effective weight loss options.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult (18 years or older) and living with obesity. This usually means having a Body Mass Index (BMI) of 35 or more. You also need to have tried to lose weight through diet at least once before, without lasting success. It's important that your weight has been generally stable for the last three months, without big ups or downs.
There are also some reasons why you might not be able to join. For example, if you have type 1 or type 2 diabetes, or any other type of diabetes, this study isn't for you. You also couldn't take part if you've recently had a serious heart problem (like a heart attack or stroke in the last three months), or if you have severe heart failure. If you've had weight-loss surgery or certain other procedures for weight loss, or if you've recently used other weight-loss medicines, you also wouldn't be eligible. The study team will carefully check all these details to make sure it's safe and right for you 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.
- Are you 18 years old or older?
- Do you have a Body Mass Index (BMI) of 35 or more?
- Have you tried to lose weight through diet in the past?
- Do you NOT have type 1 or type 2 diabetes?
- Have you NOT had a heart attack, stroke, or severe heart failure in the last 3 months?
- Have you NOT had weight-loss surgery or used other weight-loss medicines recently?
What does participation involve?
If you decide to join this study, it would last for about two years. During this time, you would have regular visits to the clinic. At these visits, the study team would give you the study medicine (either EloraTZP, one of the individual medicines, or the placebo). You would also have check-ups, which might include blood tests, measuring your weight, and checking your general health to see how you're getting on and if the treatment is helping.
It's important to remember that you wouldn't know which treatment you are receiving (the actual medicine or the placebo) because the study is 'blinded'. This helps make sure the results are fair. The study team will provide all the necessary care related to the trial and will be there to answer any questions you have throughout your participation.
Potential risks and benefits
Locations (155)
- Care Access - 801 South Power Road, MesaVerified postcodeMesa, United States
- Headlands Research - ScottsdaleVerified postcodeScottsdale, United States
- Tucson Clinical Research InstituteVerified postcodeTucson, United States
- Valley Clinical Trials, Inc.Verified postcodeCovina, United States
- Los Angeles Institute for Metabolic ResearchVerified postcodeLos Angeles, United States
- Peninsula Research AssociatesVerified postcodeRolling Hills Estates, United States
- Artemis Institute for Clinical ResearchVerified postcodeSan Diego, United States
- Southern California Clinical ResearchVerified postcodeSanta Ana, United States
- Yale University School of MedicineVerified postcodeNew Haven, United States
- JEM Research InstituteVerified postcodeAtlantis, United States
- K2 Medical Research - MaitlandVerified postcodeMaitland, United States
- Flourish Research - Miami, LLCVerified postcodeMiami, United States
Common questions
What is obesity and why is it important to treat?
Obesity means carrying too much body fat, which can affect your health in many ways, like increasing your risk of heart problems, stroke, and certain cancers. Finding effective treatments helps people live healthier lives.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the real medicine but contains no active ingredients. It's used in studies to help researchers see if the actual medicine works better than just a fake treatment.
Will I know if I'm getting the real medicine or the placebo?
No, in this study, neither you nor the study doctors will know whether you're getting the active medicine or the placebo. This is called 'blinding' and it helps make the study results as fair and accurate as possible.
How long will I be in the study?
If you decide to join, your participation in the study would last for about two years.
Can I leave the study if I change my mind?
Yes, absolutely. You are a volunteer and can choose to leave the study at any time, for any reason, without having to explain why. It won't affect your future 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
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