A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes
The goal of this clinical trial is to learn about the effect of the study drug (ZT-01) on low blood sugar (hypoglycemia) in adults with type 1 diabetes (T1D) who have been having low blood sugars ("hypos") at night. ZT-01 increases the amount of a hormone called glucagon during low blood sugar, and this may help preven
| Condition(s) | Type 1 Diabetes Mellitus With Hypoglycemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to learn about the effect of the study drug (ZT-01) on low blood sugar (hypoglycemia) in adults with type 1 diabetes (T1D) who have been having low blood sugars ("hypos") at night. ZT-01 increases the amount of a hormone called glucagon during low blood sugar, and this may help prevent the occurrence of hypos. The main questions this trial aims to answer are whether ZT-01 lowers the number of hypos happening at night, and what its effects are on blood sugar levels. The safety of ZT-01 will also be measured. Participants will be asked to wear a study-provided continuous glucose monitor (CGM) during two 4-week periods when they will self-inject the study drug before bed. They will get ZT-01 at one of three dose levels during one period, and placebo (which l |
| Who can participate | Inclusion Criteria: * Has type 1 diabetes for at least 5 years * is at risk of nocturnal hypoglycemia (if using personal CGM, time below 54 mg/dL at least 1% over previous 4 weeks at screening; if not using personal CGM then recent history suggestive of nocturnal hypoglycemia at screening and time below 54 mg/dL at least 1% over 4 weeks using blinded study CGM during additional screening) * HbA1c at screening \</= 10.0% * Body mass index (BMI) at screening \>/=18.5 to \<33 kg/m2 Exclusion Criteria: * Has been hospitalized for diabetic ketoacidosis (DKA) more than once within previous 6 months * Has experienced \>/= 1 severe hypoglycemia (requiring assistance) during previous 4 weeks or \>2 in previous 3 months * Diagnosis of type 2 diabetes, pheochromocytoma, insulinoma, glucagonoma, acrom |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Zucara Therapeutics Inc. |
| Locations | Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Escondido, California, United States; Los Angeles, California, United States; San Carlos, California, United States; Aurora, Colorado, United States (+40 more sites) |
| Start date | 2023-07-28 |
| NCT ID | NCT05762107 |
| Official listing | https://clinicaltrials.gov/study/NCT05762107 |