A 48-week Phase 2 Multicenter Controlled Pharmacokinetic and Pilot Efficacy Trial of Subcutaneous OPT101 in Patients with Type 1 Diabetes Mellitus
To explore the effect of OPT101 treatment on pancreas production in patients with T1DM
Why this Research Matters
This is a 48-week research study with OPT101, which is given as a subcutaneous injection 3 times per week. Participants will complete a screening visit, and if eligible, complete treatment and follow-up. Study procedures include things like signing consent, physical exams, vitals, blood draws, mixed meal tolerance tests, eDiary completion, medication and health review, and study medication administration.
Who can Participate
Adult
1. 18-50 years old 2. 0-10 years from T1D diagnosis 3. Medically stable 4. Avoid pregnancy
Study ID
Protocol Number: 25-1730
Meet the Team
Kimberly Simmons, MD, MPH/MSPH
Principal Investigator