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

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

Phase 2 Interventional Zucara Therapeutics Inc. · NCT05762107

This study is testing if a new drug called ZT-01 can help adults with type 1 diabetes avoid low blood sugar at night.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment186 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorZucara Therapeutics Inc. Industry-sponsored
Locations46 sites (Birmingham, Alabama and 45 other locations)
Trial IDNCT05762107 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of ZT-01, a drug designed to increase glucagon levels, on preventing nocturnal hypoglycemia in adults with type 1 diabetes. Participants will self-inject ZT-01 or a placebo before bed and wear a continuous glucose monitor to track blood sugar levels over two 4-week periods. The study aims to determine whether ZT-01 can reduce the frequency of nighttime low blood sugar episodes and assess its safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults with type 1 diabetes for at least 5 years who are at risk of nocturnal hypoglycemia.

Not a fit: Patients with a history of severe hypoglycemia or certain other diabetes-related conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of nighttime hypoglycemia for patients with type 1 diabetes.

How similar studies have performed: While there have been studies on glucagon and hypoglycemia, this specific approach with ZT-01 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 45 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Type 1 Diabetes Mellitus With Hypoglycemianocturnal hypoglycemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.