This study is testing the safety of a new treatment, NNC0361-0041, in adults with T1D. The treatment is a plasmid vector designed to transfer DNA into cells, where it can communicate with the immune system.
Earlier studies in the lab show this treatment might retrain the immune system to stop attacking insulin-producing beta cells.
While plasmids are small circular pieces of DNA, they do not change your DNA. They are currently being studied in many clinical trials for other conditions.
As with any medical intervention, there are risks and benefits to participating in this study. Before you decide to participate, a member of our research team will explain all potential risks and benefits and answer any questions you may have.
To participate in this study, you need to:
• be between the ages of 18 and 45 in the U.S
• have had a T1D diagnosis within the past 48 months
• have at least one diabetes-related autoantibody at screening
• have an HbA1c ≤8.5% at screening
• have measurable C-peptide at screening
• be willing to comply with intensive diabetes management
• be up to date on recommended immunizations
• NOT be pregnant or planning to be pregnant
• meet other study requirements
This study has 2 phases: treatment and follow up.
In the treatment phase, participants will visit a TrialNet clinical research site once a week for 12 weeks. At each visit, they will receive an injection (treatment or placebo). For the first visit, they will stay at the clinical research site as an inpatient for 48 hours of observation. The remaining treatment visits will last 3-7 hours, depending on observation and testing.
In the follow up phase, participants will have a study visit at months 3, 4, 6 and 12. These visits will last 1-4 hours, depending on which tests are needed.
Because this is the first time this treatment is being tested in people, it requires a staggered enrollment process that allows TrialNet to evaluate the safety of the treatment at each dose before enrolling additional participants.
Step 1: Interest and Availability
Let us know you’re interested and available by contacting us. Your assigned TrialNet site will work closely with you to make sure you understand the study and time commitment, as well as answer any questions you have.
Step 2: Screening Visit to Confirm Eligibility
Participants will go to a TrialNet site for a screening visit. The results of the screening visit will determine who is eligible to join the study. Because of the unique enrollment process for this study, there may be times that we screen more people than we will need.
Step 3: Enrollment Assignment
In each group, participants will enroll and begin treatment in a staggered fashion. We will first enroll 2 participants and evaluate for safety, then 3 and evaluate for safety, followed by the remaining 7.
- Because a limited number of “slots” are available in each group, it is important to communicate your availability. Your study team will work closely with you and notify you when a slot is available. You can decide at that time if you’re ready to continue in the study.
- If we don’t hear back from you, or the timing doesn’t work for you, we’ll move to the next participant in line. Also, depending how long it’s been since you had your study screening visit, you may need additional tests to be sure you’re still eligible.
To find out if you qualify for the TOPPLE Study, please contact us.