J3R-MC-YDAS: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once-Weekly Eloralintide in Adult Participants With Obesity or Overweight, Type 2 Diabetes, and Increased CV Risk
This clinical trial is researching a potential new medicine named eloralintide. It is designed for adults living with type 2 diabetes who carry excess body weight and have an increased risk of cardiovascular (heart and blood vessel) disease. Having diabetes alongside extra weight can put strain on the heart. Researchers want to find out whether taking eloralintide once a week can help reduce body weight and improve long-term blood sugar levels (HbA1c). Participants will be randomly chosen to receive either eloralintide or an inactive dummy treatment called a placebo. Because this is a double-blind trial, neither you nor your study doctor will know which treatment you are given. The findings from this trial will help doctors understand if eloralintide is safe and effective for protecting heart health and managing weight in people with diabetes.
At a glance
What is this study about?
Many people live with both type 2 diabetes and excess body weight. When these conditions occur together, they can place extra stress on your heart and circulation, raising the chance of heart attacks or strokes. Finding medicines that can help manage blood sugar while also supporting weight loss is an important goal for modern healthcare.
This trial investigates an experimental medicine called eloralintide, which is given as a weekly injection under the skin. Researchers are measuring how well it helps participants lose weight and improve their HbA1c, which is a standard blood test showing average blood sugar levels over the past few months. The effects will be compared against a placebo, which looks identical but contains no active medicine.
Because this is a Phase 3 study, earlier trials have already shown that the drug is promising. Now, researchers need to confirm these results in a much larger group of people over a longer period to make sure it is both helpful and safe. The knowledge gained could lead to new treatment options for people managing diabetes and weight-related heart risks.
Key takeaways
- Tests a new once-weekly injection called eloralintide for diabetes and weight control.
- Aimed at adults aged 18 and older with type 2 diabetes and higher heart risks.
- Compares the active drug to an inactive dummy treatment (placebo).
- Focuses on improvements in body weight and long-term blood sugar levels.
- Taking part is completely voluntary and will not affect your regular medical care.
Who may be eligible?
To be considered for this study, you must be 18 years of age or older. You need to have a confirmed diagnosis of type 2 diabetes and have a body weight that falls into the overweight or obese category. You must also have an increased risk of cardiovascular disease, which means you may have a past history of heart conditions or other health factors that affect your circulation.
You may not be able to take part if you have certain other significant medical conditions, such as severe kidney, liver, or stomach problems. You might also be excluded if you take specific medicines that cannot be safely combined with the study treatment.
Women who are pregnant, planning to become pregnant, or breastfeeding will not be eligible to participate. The study team will carefully review your full medical history and perform health checks before you can join to ensure it is safe for you.
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 aged 18 or older?
- Have you been diagnosed with type 2 diabetes?
- Do you carry excess body weight (overweight or living with obesity)?
- Do you have a higher risk of heart disease or a history of heart issues?
- Are you willing to attend regular clinic visits and take a weekly injection?
What does participation involve?
If you join the trial, you will be taught how to give yourself a weekly injection just under the skin using a simple pen device. You will attend regular visits at a local study clinic. During these check-ups, the medical team will monitor your blood pressure, measure your weight, take blood samples to check your blood sugar, and discuss any symptoms you may have. The study runs over several months, and the research team will support you closely throughout the entire process.
Potential risks and benefits
Locations (5)
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Common questions
What is a placebo?
A placebo looks just like the real medicine but has no active ingredients. Comparing the study drug to a placebo helps scientists prove whether the drug really works.
Will I know if I am getting eloralintide or the placebo?
No. To keep the results fair and unbiased, neither you nor the study team will know which treatment you are receiving until the study has finished.
How often do I need to take the study medicine?
The medicine is taken once a week as a quick injection just beneath the skin.
Does it cost anything to take part?
No, all study medications, clinic visits, and health tests are free, and you may be offered help with travel expenses.
Can I carry on seeing my regular GP?
Yes. Taking part does not replace your routine healthcare, and the trial team will keep your GP updated about your progress.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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