ZT-01 for Night-time Low Blood Sugar in Type 1 Diabetes

This study is looking at how ZT-01 affects low blood sugar (hypoglycemia) at night in adults with type 1 diabetes. ZT-01 is thought to work by increasing a hormone called glucagon during low blood sugar, which might help prevent these episodes. We want to see if ZT-01, given as a daily injection, can reduce the number of night-time low blood sugar events and what its effects are on overall blood sugar levels. We will also be checking the safety of ZT-01. You might be able to join if you are 18-75 years old, have had type 1 diabetes for at least 5 years, and experience night-time low blood sugar.

Study design
This interventional study plans to enroll 186 participants. Participants will receive either ZT-01 at different doses (7 mg, 15 mg, or 22 mg) or a placebo (an inactive substance) by daily subcutaneous injection.
What's involved
Participants will wear a continuous glucose monitor (CGM) provided by the study during two 4-week periods. During these periods, they will self-inject the study drug before bed.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, incidence of nocturnal hypoglycemia, will be measured during each 28-day treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05762107

A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes

Recruiting
PHASE2Ages 18–75InterventionalPrevention
Zucara Therapeutics Inc.
~186 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:PlaceboZT-01, 7 mgZT-01, 15 mgZT-01, 22 mg

At a glance

Recruiting sites
44 of 46 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of nocturnal hypoglycemia
Measured over During each 28 day treatment period
Type 1 Diabetes Mellitus With Hypoglycemia
46 sites across 26 states
Florida5
Ontario5
Texas4
California3
Georgia3
New York3
Maryland2
Pennsylvania2

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

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
  • Incidence of nocturnal hypoglycemiaDuring each 28 day treatment period

    Rate of nocturnal (midnight to 06:00 AM) hypoglycemic events (glucose \<54 mg/dL) lasting at least 15 minutes, compared to placebo