About the CNP-103 Clinical Trial

We’re enrolling teens and adults who were recently diagnosed with type 1 diabetes (T1D). This study is testing an investigational therapy designed to target the underlying cause of T1D.

Who Can Participate?

To join this study, you must:

  • Be 12 to 35 years of age
  • Have been diagnosed with T1D in the past 6 months
  • Be using standard diabetes treatments, including insulin therapy, a nutrition plan, regular exercise, or other relevant care
    • You will be able to stay on these treatments during the study
  • NOT be taking medicines for T1D that affect the immune system (e.g., cyclosporin, azathioprine, methotrexate, rituximab)

There are additional requirements, which will be explained to you by the study doctor.

Study Participation

Participation in this study will last about 13 months and includes up to 10 visits to the study site. Throughout participation, individuals will be closely monitored and will visit the research site regularly for tests, procedures, and health checks.

The study has 3 parts:

Screening

A study doctor will evaluate you to decide whether this study is a good match. If you decide to join, you will sign the informed consent form (ICF). If you are under 18, your parent or guardian will sign the ICF, and you will sign an assent form.

Study Treatment

You will receive the assigned study treatment and attend regular site visits. Laboratory sample collections, questionnaires, and other testing and procedures will be done depending on the visit.

Follow-Up

The study team will monitor your health after your last dose of the assigned study treatment. Laboratory sample collections, questionnaires, and other testing will be done.

See if you may qualify

About the Study Therapy

The study therapy being researched is called CNP-103. Unlike regular T1D treatments, CNP-103 is designed to “retrain” your immune system to stop the attack on your pancreas. It uses tiny particles to send signals to your body, telling it not to destroy the cells that make insulin (beta cells).

In this study, some people will get CNP-103 and others will get a placebo (a “look-alike” treatment with no medicine in it). Placebos help researchers find out how well a study therapy may work by giving them something to compare it to. In this study, participants are about 2 to 3 times more likely to receive the study therapy than the placebo.

Whether you receive CNP-103 or the placebo, you will continue your standard diabetes care, including insulin and routine monitoring, throughout the study.

What Happens in the Pancreas

Healthy Pancreas

Insulin-producing cells (called beta cells) produce the insulin your body needs to regulate blood sugar.

In a healthy body, the immune system protects you from unwanted things like germs and infections. It leaves your insulin-producing cells (called beta cells) alone, allowing them to produce the insulin your body needs to regulate blood sugar.

  • Insulin allows your body to take the energy from the food you eat and move it into your body’s cells, where it’s used for energy.

Pancreas with T1D

The immune system mistakenly attacks the beta cells in the pancreas.

In people with T1D, the immune system mistakenly attacks the beta cells in the pancreas. The damage from this attack leads to the beta cells not being able to produce insulin properly. Without insulin, sugar stays in the blood and makes the sugar levels in your blood too high, causing your body to not get enough energy where it needs it (in its cells).

Pancreas with T1D After CNP-103

The goal of CNP-103 is to protect your remaining beta cells so they can continue to produce insulin.

CNP-103 is designed to "retrain" your immune cells to recognize beta cells as friendly. By calming this autoimmune attack, the goal is to protect your remaining beta cells so they can continue to naturally produce insulin.

How Is the Study Treatment Given?

You will receive your assigned study treatment (study therapy or placebo) through a small tube that will be inserted into a vein in your arm, known as an IV or intravenous infusion. The assigned study treatment will slowly drip from a bag, which will take a few hours. You will be closely watched during and immediately after that time.

No-Cost Treatment and Support

All participants in this study will receive the assigned study treatment and all study-related procedures at no cost. They will also be provided with a Continuous Glucose Monitor (CGM) to wear at certain points during the study and a Blood Glucose Monitor (BGM) to use if desired.

Please note, the study CGM will provide data automatically to the research site; those readings will not be shown to participants and therefore cannot be used for participants to track their blood sugar. Participants will need to continue to use their own CGM to manage their T1D, or use the BGM provided.

In addition, participants may receive payments to help cover travel costs and their time in the study, along with ongoing support from the study doctor and site staff, who will monitor their health throughout the study.

CNP-103 Information for Teens

We’ve created a page to help teens better understand what the CNP-103 Clinical Trial is, what participation may be like, and what to expect during the study.

Learn more