RecruitingPHASE2INTERVENTIONAL

Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus

This study is investigating a new medication, Rezpegaldesleukin, for individuals who have recently been diagnosed with Type 1 Diabetes (within 100 days). The main goal is to explore whether this medicine can help the body's own cells continue to produce insulin. Participants aged 8 to 45 will be randomly assigned to receive either the new medicine or a placebo (a dummy treatment, like a sugar pill, that contains no active medicine). Neither the patient, their doctors, nor the researchers will know who is receiving which treatment. The medicine or placebo will be given by injection every two weeks for six months, followed by another six months of observation. This is a Phase 2 study, meaning it's still in the early stages of testing. All care and monitoring will be provided in a supportive environment.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Enrolment target

Start

14 May 2026

Estimated completion

25 May 2028

Type 1 Diabetes Mellitus

What is this study about?

This research study is about a new medicine called Rezpegaldesleukin for people who have recently been told they have Type 1 Diabetes. When someone has Type 1 Diabetes, their body's immune system mistakenly attacks and destroys the cells in the pancreas that make insulin. Insulin is a vital hormone that helps turn sugar from food into energy for the body. Without enough insulin, blood sugar levels can become too high, which can lead to serious health problems.

The researchers want to see if Rezpegaldesleukin can help protect these insulin-making cells, allowing the body to keep making some of its own insulin for longer. This could potentially make managing Type 1 Diabetes easier in the future. It's important to remember that this is a research study, and we're still learning about this new medicine. Studies like this are how we find better ways to treat medical conditions.

In this study, participants will be randomly chosen to receive either the new medicine or a placebo. A placebo looks just like the real medicine but doesn't contain any active ingredients. This helps researchers fairly compare how well the new medicine works. Neither you, your doctors, nor the study team will know which treatment you are receiving until after the study is over. This is called a "double-masked" study and it's a standard practice in medical research to ensure the results are as accurate as possible.

Key takeaways

This study is testing a new medicine for people recently diagnosed with Type 1 Diabetes.
The aim is to see if the medicine can help the body keep making its own insulin.
Participants will receive the new medicine or a dummy treatment (placebo) by injection.
The study involves regular clinic visits for injections and health checks over about a year.
Taking part helps researchers learn and improve treatments for Type 1 Diabetes.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To join this study, you must be between 8 and 45 years old. A key requirement is that you must have been diagnosed with Type 1 Diabetes within the last 100 days. Also, blood tests must show specific markers that confirm your immune system has recently attacked your insulin-producing cells, and you still have some insulin-producing ability.

You also need to be at a healthy weight for your age and be willing to actively manage your diabetes. There are also specific requirements about having certain vaccinations and being free from certain viral infections before starting the study. For younger participants, a parent or guardian will need to give permission.

It's important to discuss all your health conditions and medications with the study team to ensure this study is safe and right for you. They will review all criteria carefully to see if you are a good fit.

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 between 8 and 45 years old?
Were you diagnosed with Type 1 Diabetes within the last 100 days?
Do blood tests show your immune system has recently attacked your insulin cells?
Do you still have some ability to make your own insulin?
Are you willing to actively manage your diabetes with your healthcare team?
Are you able to attend all clinic visits for about a year?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you will receive either the study medicine or a placebo injection under the skin every two weeks for about six months (26 weeks). These injections will be given at the study clinic. You'll need to visit the clinic regularly for these injections and for important medical tests. These tests include blood tests to measure your insulin levels and check your general health, particularly at the beginning of the study, and then at 3, 6, and 12 months. After the six months of treatment, you will continue to have follow-up visits for another six months, bringing the total time you’re involved in the study to about a year. During this time, you'll continue to manage your diabetes as you normally would, with support from the study team.

Potential risks and benefits

Potential benefits of taking part in this study may include the possibility that the new medicine could help your body continue to make insulin, potentially making your diabetes easier to manage. You would also receive close medical monitoring and care from a specialist team throughout the study, and your participation helps advance our understanding of Type 1 Diabetes for others. However, like all medicines, Rezpegaldesleukin may have side effects, which the study team will discuss with you in detail. There's also no guarantee that the medicine will be effective for you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

University of Pittsburgh
Verified postcode
Pittsburgh, United States· Recruiting
Vanderbilt University
Verified postcode
Nashville, United States· Not yet recruiting
University of British Columbia
Verified postcode
Vancouver, Canada· Not yet recruiting

Common questions

What is a 'Phase 2 study'?

Phase 2 means this is an early stage of testing. The treatment has been found safe in a small number of people and now more information on its safety and effectiveness is being gathered in a larger group.

What is a placebo?

A placebo is a dummy treatment. It looks exactly like the real medicine but doesn't contain any active ingredients. This helps researchers compare the real medicine's effects fairly.

Will I know if I'm getting the medicine or the placebo?

No, this is a 'double-masked' study, meaning neither you, your doctor, nor the researchers will know who is receiving which treatment until the study is complete. This helps keep the results unbiased.

How long will I be involved in the study?

You will receive treatment or placebo injections for about six months (26 weeks). After that, you'll have follow-up visits for another six months, making your total participation about one year.

Can I stop participating in the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

Jessica Conaty

jessica.conaty@epi.usf.edu 813-396-9234 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.