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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus With Hypoglycemia

In brief

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).

Key facts

Study ID: NCT05762107
Run by: Zucara Therapeutics Inc.
People needed: 186
Starts: 2023-07-28
Expected to finish: 2027-05-01
Last updated by the study team: 2026-04-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 it is running

Mount Sinai Hospital: Leadership Sinai Centre for Diabetes — Toronto, Ontario, Canada (enrolling)
Medical Investigations Indications Inc. — Little Rock, Arkansas, United States (enrolling)
Headlands Research — Escondido, California, United States (enrolling)
USC Keck Medicine Eastside Center for Diabetes — Los Angeles, California, United States (enrolling)
Centricity Research Toronto — Toronto, Ontario, Canada (enrolling)
Kirklin Clinic of UAB Hospital-Endocrinology/Diabetes Clinic — Birmingham, Alabama, United States (enrolling)
Barbara Davis Center for Diabetes — Aurora, Colorado, United States (enrolling)
Yale University - Diabetes Research Office — New Haven, Connecticut, United States (enrolling)
East Coast Institute for Research LLC — Jacksonville, Florida, United States (enrolling)
Suncoast Clinical Research — New Port Richey, Florida, United States (enrolling)
Hanson Diabetes Center — Port Charlotte, Florida, United States (enrolling)
University of South Florida Diabetes & Endocrinology Clinic — Tampa, Florida, United States (enrolling)
Metabolic Research Institute — West Palm Beach, Florida, United States (enrolling)
Atlanta Diabetes Associates — Atlanta, Georgia, United States (enrolling)
Physicians Research Associates LLC — Lawrenceville, Georgia, United States (enrolling)
East Coast Institute for Research — Macon, Georgia, United States (enrolling)
University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
IU Health University Hospital — Indianapolis, Indiana, United States (enrolling)
University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
Ochsner Clinic Foundation — New Orleans, Louisiana, United States (enrolling)
Baltimore VA Medical Center — Baltimore, Maryland, United States (enrolling)
MedStar Good Samaritan Hospital — Baltimore, Maryland, United States (enrolling)
Elite Research Center — Flint, Michigan, United States (enrolling)
University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
Palm Research Center, Inc. — Las Vegas, Nevada, United States (enrolling)

Full record on ClinicalTrials.gov

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