A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes
NCT ID: NCT05762107
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
186 participants
INTERVENTIONAL
2023-07-28
2027-05-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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ZT-01 7 mg
Participants receive placebo and ZT-01 7 mg each by subcutaneous injection daily for 28 days, randomized to order
Placebo
Subject receives Placebo by subcutaneous injection daily for 28 days
ZT-01, 7 mg
Subject receives ZT-01 7 mg by subcutaneous injection daily for 28 days
ZT-01 15 mg
Participants receive placebo and ZT-01 15 mg by subcutaneous injection daily for 28 days, randomized to order
Placebo
Subject receives Placebo by subcutaneous injection daily for 28 days
ZT-01, 15 mg
Subject receives ZT-01 15 mg by subcutaneous injection daily for 28 days
ZT-01 22 mg
Participants receive placebo and ZT-01 22 mg by subcutaneous injection daily for 28 days, randomized to order
Placebo
Subject receives Placebo by subcutaneous injection daily for 28 days
ZT-01, 22 mg
Subject receives ZT-01 22 mg by subcutaneous injection daily for 28 days
Interventions
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Placebo
Subject receives Placebo by subcutaneous injection daily for 28 days
ZT-01, 7 mg
Subject receives ZT-01 7 mg by subcutaneous injection daily for 28 days
ZT-01, 15 mg
Subject receives ZT-01 15 mg by subcutaneous injection daily for 28 days
ZT-01, 22 mg
Subject receives ZT-01 22 mg by subcutaneous injection daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Zucara Therapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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Headlands Research
Escondido, California, United States
USC Keck Medicine Eastside Center for Diabetes
Los Angeles, California, United States
LCGK Research
San Carlos, California, United States
East Coast Institute for Research LLC
Jacksonville, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Hanson Diabetes Center
Port Charlotte, Florida, United States
Metabolic Research Institute
West Palm Beach, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Physicians Research Associates LLC
Lawrenceville, Georgia, United States
East Coast Institute for Research
Macon, Georgia, United States
IU Health University Hospital
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Baltimore VA Medical Center
Baltimore, Maryland, United States
MedStar Good Samaritan Hospital
Baltimore, Maryland, United States
Elite Research Center
Flint, Michigan, United States
Palm Research Center, Inc.
Las Vegas, Nevada, United States
Albany Medical Center
Albany, New York, United States
NYC Research Inc.
Long Island City, New York, United States
Lucas Research Inc.
Morehead City, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, United States
Texas Diabetes & Endocrinology, PA
Austin, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
Southern Endocrinology Associates
Mesquite, Texas, United States
Diabetes & Glandular Disease Clinic
San Antonio, Texas, United States
Diabetes & Endocrine Treatment Specialists
Sandy City, Utah, United States
Centricity Research Calgary Endocrinology
Calgary, Alberta, Canada
BC Diabetes
Vancouver, British Columbia, Canada
Centricity Research Barrie Endocrinology
Barrie, Ontario, Canada
Centricity Research Vaughan Endocrinology
Concord, Ontario, Canada
Centricity Research Etobicoke Endocrinology
Etobicoke, Ontario, Canada
Centricity Research Toronto
Toronto, Ontario, Canada
Mount Sinai Hospital: Leadership Sinai Centre for Diabetes
Toronto, Ontario, Canada
Countries
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Facility Contacts
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Other Identifiers
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ZT01-CL-2001
Identifier Type: -
Identifier Source: org_study_id
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