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Type 1 Diabetes (T1D) is a chronic disease that occurs when the pancreas does not make enough insulin. There are currently no approved treatments for curing Type 1 Diabetes. The investigational drug OPT101 has shown promise in treating T1D in mice. However, researchers do not know how the drug works in people diagnosed with T1D. Before you can join the study, you will visit the clinic for a physical exam, answer health questions, and provide blood and urine samples. If you can get pregnant, you will also take a pregnancy test. You will also be asked to fast before your visit for a test that measures how much insulin your body makes. If you can join the study, you will be placed into one of two groups. One group will receive OPT101, and the other group will receive a placebo. A placebo looks like the study drug but does not have active medicine. You will not be able to choose your group. You will have 2 out of 3 chances to receive OPT101 vs placebo. At your first study visit, the study team will teach you how to use the study drug and give you your first dose. You will stay at the clinic for about 4 hours so the team can collect blood samples and monitor your health. During the study, you will take the study drug 3 times each week at home, wear a continuous glucose monitor (CGM), complete electronic diaries, and check in with the study team as needed. You will attend a total of 11 clinic visits over one year. Some visits will require fasting before an insulin production test, and you will stay at the clinic for a short observation period after receiving the study drug. You may receive up to $2,425 for completing all study visits. The study will also reimburse out-of-pocket study-related expenses.

Who can Participate

You may be able to join this study if you are between 18 and 50 years old, were diagnosed with T1D in the past 10 years and are medically stable. You cannot join this study if you are pregnant or breastfeeding.

Study ID