Tests ZT-01 for night-time low blood sugar in adults with type 1 diabetes
Tests ZT-01 to reduce night-time low blood sugar in adults with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes
Key facts
- Where
- Barrie, Calgary, Concord, Etobicoke, Toronto, and Vancouver, CanadaSee the 8 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05762107, who can take part
Where in Canada
- Centricity Research Barrie EndocrinologyBarrie, CanadaNo longer taking part
- Centricity Research Calgary EndocrinologyCalgary, CanadaTaking people
- Richmond Road Diagnostic & Treatment Centre, Clinical Trials UnitCalgary, CanadaTaking people
- Centricity Research Vaughan EndocrinologyConcord, CanadaTaking people
- Centricity Research Etobicoke EndocrinologyEtobicoke, CanadaTaking people
- Centricity Research TorontoToronto, CanadaTaking people
- Mount Sinai Hospital: Leadership Sinai Centre for DiabetesToronto, CanadaTaking people
- BC DiabetesVancouver, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zucara Therapeutics Inc.
- Trial code
- NCT05762107
- Record updated
- 29 April 2026
- Original description
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.Read full original descriptionShow less
A Phase 2a Randomized, Double-blind, Placebo-controlled, Multiple-dose, Crossover Study of the Effect of ZT-01 on Frequency of Nocturnal Hypoglycemia in Type 1 Diabetes Mellitus
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).
Inclusion: 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: 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.