NCT05762107 A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes
| NCT ID | NCT05762107 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Zucara Therapeutics Inc. |
| Condition | Type 1 Diabetes Mellitus With Hypoglycemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 186 participants |
| Start Date | 2023-07-28 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 186 participants in total. It began in 2023-07-28 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 looks like the study drug but doesn't contain the active ingredient) during the other. Neither the participant nor the study site will know what they are receiving during each treatment period or see data from the CGM. The participant will continue to use their usual methods of measuring blood sugar (including their personal CGM) and giving insulin during the study. The participant will be asked to complete a short diary each evening, and will be asked to upload the CGM data to a study phone every day. If a participant uses their own CGM and is willing to share information on how often they have low blood sugar with the study site at the first visit to see if they meet study entry requirements, they will have 6 study visits, 2 study phone calls, and be in the study for about 16 weeks. If they don't use CGM or don't want to share their information, then they will be asked to wear a study CGM for an extra 4 weeks to find out how many low blood sugars they have, and will have an extra visit. Study participants will be asked to give blood and urine for testing to see whether they meet the requirements to enter the study, and at the start and end of each treatment period to see if the study treatment has any effects. They will also have their blood pressure and temperature taken at each study visit, and have an ECG at 4 visits to measure the electrical activity of their heart. Some participants will be asked to also take part in a sub-study where their blood level of ZT-01 and glucagon is measured, after the first and last dose. They will be asked to stay at the study site overnight for each set of measurements (4 in total).
Eligibility Criteria
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, acromegaly, Cushing's disease, glycogen storage disease, adrenal insufficiency * Clinically significant kidney disease * Abnormal liver function
Frequently Asked Questions
Who can join the NCT05762107 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Type 1 Diabetes Mellitus With Hypoglycemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05762107 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05762107 currently recruiting?
Yes, NCT05762107 is actively recruiting participants. Visit ClinicalTrials.gov or contact Zucara Therapeutics Inc. to inquire about joining.
Where is the NCT05762107 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Escondido, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT05762107 clinical trial?
NCT05762107 is sponsored by Zucara Therapeutics Inc.. The trial plans to enroll 186 participants.
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