RecruitingPHASE1INTERVENTIONAL

Clamp Study to Estimate the Relative Potency of GZR33 Versus Insulin Degludec at Steady State

This research study, called a 'Clamp Study', is looking into a new type of insulin, GZR33. It's designed for adults aged 18 to 64 who have Type 1 Diabetes. The main goal is to understand how GZR33 works in the body and to compare its strength and effects against an insulin already in use, called insulin degludec. Researchers will also check if GZR33 is safe and well-tolerated. This is an early stage study (Phase 1), meaning it's one of the first times this new insulin is being tested in humans. The findings will help determine if GZR33 could be a useful new treatment option in the future.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Gan and Lee Pharmaceuticals, USA

Enrolment target

Start

13 Oct 2025

Estimated completion

15 Apr 2026

Type 1 Diabetes Mellitis

What is this study about?

Imagine you have Type 1 Diabetes, and your body needs extra insulin to control blood sugar. Researchers are always looking for new and better ways to provide this insulin. This particular study is an early step in testing a new insulin called GZR33. They want to see how it works in the body, how quickly it starts working, how long it lasts, and how strong it is at lowering blood sugar, especially compared to an insulin already used, called insulin degludec. This comparison helps them understand if the new insulin might offer any advantages.

This study is called a 'Phase 1' trial, which means it's one of the first times this new insulin is being given to people. The main focus at this stage is to make sure it's safe and to understand how the body handles it. They'll also be carefully checking for any side effects and how well people tolerate it. The information gathered from this study is really important for deciding if GZR33 should be studied further.

By taking part, you would be helping medical science learn more about new diabetes treatments. The results from studies like this are crucial for developing new medicines that could improve the lives of people with Type 1 Diabetes in the future. It's a key step in bringing potentially better treatment options to patients.

Key takeaways

This study evaluates a new insulin, GZR33, for Type 1 Diabetes.
It compares GZR33's effects, safety, and strength with an existing insulin.
You'll receive close medical supervision if you participate.
Participation involves clinic visits and careful blood sugar monitoring.
It's an early-stage study, helping to inform future diabetes treatments.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults with Type 1 Diabetes. To be considered, you should be between 18 and 64 years old and have had Type 1 Diabetes for at least one year. Your blood sugar control, measured by a test called HbA1c, should be at or below 9.0%. Your body weight should also be within a healthy range, as indicated by your Body Mass Index (BMI).

You also need to be on a stable insulin treatment plan for at least two months, with your daily insulin dose falling within a specific range. Your blood pressure should be normal, and you shouldn't have any other significant health problems.

There are also some reasons why you might not be able to join. For example, if you've had severe low blood sugar (hypoglycemia) often in the last six months, or if you don't notice when your blood sugar is getting too low. Also, if your kidney function isn't within a healthy range, you wouldn't be able to participate. The medical team will carefully check all these details to see if the study is right 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 between 18 and 64 years old?
Have you had Type 1 Diabetes for at least 12 months?
Is your HbA1c (a measure of average blood sugar) 9.0% or less?
Are you on a stable insulin treatment plan currently?
Do you generally feel when your blood sugar is getting low?
Do you have good kidney function and blood pressure?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to a clinic. You would be given either the new insulin, GZR33, or insulin degludec, so researchers can compare them. During these visits, medical staff would closely monitor your blood sugar, take blood and urine samples, and check your general health.

One key part of this study is something called a 'clamp study'. This is a special way to measure how well insulin works by keeping your blood sugar levels very steady and carefully controlled. This means frequent blood tests and adjustments during certain periods.

Throughout your time in the study, you would have regular check-ups to make sure you are doing well and to record any effects of the treatment. The total duration of your involvement in the study, including all visits and follow-ups, would be explained in detail by the study team.

Potential risks and benefits

Participating in research studies like this can lead to many benefits for future patients, but there can also be some risks for you. A potential benefit is that you would receive careful medical monitoring and close attention to your diabetes management throughout the study. You might also gain access to a new treatment before it's widely available. However, because this is an early-stage study, the new insulin GZR33 might not be more effective than current treatments, and there could be unknown side effects. You might also experience side effects common with insulin use, such as low blood sugar episodes. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Profil Institut
Verified postcode
Neuss, Germany· Recruiting
Profil
Verified postcode
Neuss, Germany· Recruiting

Common questions

What is GZR33?

GZR33 is a new type of insulin being developed and tested for people with Type 1 Diabetes.

What is the main goal of this study?

The main goal is to understand how well GZR33 works, how safe it is, and to compare its effects to an existing insulin called insulin degludec.

Who can take part in this study?

Adults aged 18-64 with Type 1 Diabetes who meet specific health and diabetes control criteria.

Will I know if I'm getting the new insulin or the old one?

This would be explained by the study team. Often in these studies, participants might not know which treatment they are receiving until later, but this will always be made clear to you.

What does a 'clamp study' mean?

It's a special medical test where doctors carefully control your blood sugar levels to precisely measure how well insulin is working.

How to find out more

Andre Feldmann

149-1226-gzr-33@profil.com +49 (0) 2131 4018 409 Official trial record

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