Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

J1I-MC-GZBU - A Phase 2b, Double-Blind Study to Investigate the Effect of LY3437943 on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

This research study, called J1I-MC-GZBU, is exploring a new investigational medication, LY3437943. We are inviting people who are overweight or obese and have chronic (long-term) kidney disease to take part. Some participants may also have type 2 diabetes. The main goal is to find out if LY3437943 can improve how well the kidneys are working. To do this, we will use a special substance called iohexol to measure kidney function accurately. Some people in the study will receive the new medicine, some will receive a dummy medicine (placebo) to compare with, and others might receive a different existing medicine called Retatrutide. This is a Phase 2b study, meaning we are still in the earlier stages of testing to understand the medicine's effects and find the right dose.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Eli Lilly & Co.

Enrolment target

Start

14 Nov 2023

Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

What is this study about?

Imagine your kidneys as very important filters, cleaning your blood and removing waste from your body. In people with chronic kidney disease, these filters don't work as well as they should, which can cause health problems over time. Being overweight or obese can also put extra strain on the kidneys. This study is designed to see if a new medicine, LY3437943, can help improve how well these kidney filters are working.

We're asking people who are adults (18 years or older) and fit the description of being overweight or obese with chronic kidney disease to join. It's important to know that you don't have to have type 2 diabetes to take part, though some participants might. By studying this new medicine, we hope to find new ways to help people keep their kidneys healthier.

This is a 'Phase 2b' study, which means it's still in the earlier stages of testing. We want to learn more about the medicine's effects, how safe it is, and whether it can truly make a difference in kidney function. Your participation is really important because it helps medical professionals understand if this new treatment could be a good option for people in the future.

Key takeaways

This study is for adults with long-term kidney disease who are overweight or obese.
It's testing a new medicine, LY3437943, to see if it helps kidney function.
Participation involves regular clinic visits and taking a study medication.
You might receive the new medicine, a dummy pill, or Retatrutide.
You don't need to have type 2 diabetes to take part.
It's an early-stage study, so the effects of the new medicine are still being explored.

Who may be eligible?

To be considered for this study, you need to be an adult, at least 18 years old. There's no upper age limit, so people of all adult ages can potentially join. Both men and women are welcome to participate.

The main health conditions we are looking for in participants are being overweight or obese, AND having chronic (long-term) kidney disease. This means your kidneys haven't been working perfectly for a while. You might have been diagnosed with chronic kidney disease by your doctor.

It's important to note that you don't necessarily need to have type 2 diabetes to join. Some participants will have type 2 diabetes along with their kidney disease and being overweight/obese, while others will have the kidney disease and be overweight/obese without type 2 diabetes. The study aims to look at how the medicine works across these different groups.

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?
Have you been diagnosed with chronic (long-term) kidney disease?
Are you considered overweight or obese?
Are you willing to attend regular clinic visits and take study medication?
Are you willing to receive either a new drug, a dummy drug, or Retatrutide?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your participation will involve a few key things. You will have regular visits to the clinic, where doctors and nurses will check your general health, measure your kidney function, and ask about any changes you've noticed. A special test using a harmless substance called iohexol will be used to get a very precise measurement of how well your kidneys are filtering blood.

You will be given one of the study treatments: either the new medicine LY3437943, a 'dummy' medicine called a placebo (which looks exactly like LY3437943 but has no active ingredients), or another medicine called Retatrutide. You won't know which one you are receiving, and neither will your study doctor, to ensure the results are unbiased. The medication will need to be taken as instructed.

There will also be follow-up appointments after you finish taking the study medicine to make sure you are doing well and to collect final health information. The total length of your participation in the study, including all visits and follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of joining this study is that you will receive close medical attention and monitoring. You might also be among the first to receive a new medication that could potentially improve your kidney function, though this is not guaranteed as it's an investigational medicine. Potential risks could include side effects from the study medication, or discomfort from blood tests and other assessments. All possible risks and benefits will be fully explained to you before you decide to participate. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Italy

Common questions

What is 'chronic kidney disease'?

Chronic kidney disease means your kidneys aren't working as well as they should be, and this has been a long-term problem.

What is a 'Phase 2b' study?

This is an early stage of research where we are testing a new medicine to see if it works and to find the best dose, as well as checking for safety.

Will I know if I'm getting the new medicine or a dummy pill?

No, you won't. This is called 'double-blind,' which means neither you nor your study doctor will know, to keep the study fair and scientific.

What is iohexol used for?

Iohexol is a special substance we use to accurately measure how well your kidneys are filtering your blood.

Do I have to have diabetes to join?

No, you don't. While some participants might have type 2 diabetes, others will not. The main requirements are being overweight or obese and having chronic kidney disease.