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.
Key facts
- Who runs it
- Zucara Therapeutics Inc.
- Where
- Barrie, Calgary, Concord, Etobicoke, Toronto, and Vancouver, CanadaSee the 8 sitesAlso in 1 other country, 38 sites
- Trial code
- Registry title
- A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 186 people, planned
- Started
- 28 Jul 2023
- Expected to end
- May 2027
- Type of study
- Interventional, 3 groups
- Treatments tested
- Placebo
- ZT-01, 7 mg
- ZT-01, 15 mg
- ZT-01, 22 mg
- Record updated
- 29 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 1 diabetes who have low blood sugar at night. It tests whether ZT-01 lowers the number of these night-time lows.
- Age
- 18 to 75 years
- Sex
- All sexes
- Disease stage
- Type 1 diabetes for at least 5 years, with a risk of low blood sugar at night.
- Biomarker or test result
- Time with blood sugar below 54 mg/dL (3 mmol/L) at least 1% over 4 weeks. HbA1c 10.0% (86 mmol/mol) or lower. Body mass index from 18.5 to under 33 kg/m2.
Main reasons for not taking part
- Hospitalized for diabetic ketoacidosis more than once in the past 6 months
- Severe low blood sugar needing help: 1 or more in the past 4 weeks, or more than 2 in the past 3 months
- Type 2 diabetes or certain hormone-related conditions, for example Cushing's disease or adrenal insufficiency
- Clinically significant kidney disease
- Abnormal liver function
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Canada
Also in 1 other country, 38 sites
- Centricity Research Barrie EndocrinologyBarrie, CanadaNo longer taking part
- Centricity Research Calgary EndocrinologyCalgary, CanadaContact: Buki Ajala, MBBSTaking people
- Richmond Road Diagnostic & Treatment Centre, Clinical Trials UnitCalgary, CanadaContact: Michelle SmithTaking people
- Centricity Research Vaughan EndocrinologyConcord, CanadaContact: Sanjida NishatTaking people
- Centricity Research Etobicoke EndocrinologyEtobicoke, CanadaContact: Sneha SharmaTaking people
- Centricity Research TorontoToronto, CanadaContact: Janessa GabuyoTaking people
- Mount Sinai Hospital: Leadership Sinai Centre for DiabetesToronto, CanadaContact: Andrej OrszagTaking people
- BC DiabetesVancouver, CanadaContact: Alireza MoshiriTaking people
About the trial
What the trial wants to find out
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
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).
The 3 groups in the trial
- ZT-01 7 mgTreatment being tested
Participants receive placebo and ZT-01 7 mg each by subcutaneous injection daily for 28 days, randomized to order
Treatment: Placebo and ZT-01, 7 mg
- ZT-01 15 mgTreatment being tested
Participants receive placebo and ZT-01 15 mg by subcutaneous injection daily for 28 days, randomized to order
Treatment: Placebo and ZT-01, 15 mg
- ZT-01 22 mgTreatment being tested
Participants receive placebo and ZT-01 22 mg by subcutaneous injection daily for 28 days, randomized to order
Treatment: Placebo and ZT-01, 22 mg
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Tests ZT-01 for night-time low blood sugar in adults with type 1 diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05762107, who can take part
- Record updated
- 29 April 2026