A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes (ZONE)
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| ClinicalTrials.gov Identifier: NCT05762107 |
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Recruitment Status :
Recruiting
First Posted : March 9, 2023
Last Update Posted : April 11, 2024
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 1 Diabetes Mellitus With Hypoglycemia | Drug: Placebo Drug: ZT-01, 7 mg Drug: ZT-01, 15 mg Drug: ZT-01, 22 mg | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 168 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention Model Description: | The participant will be randomized to receive placebo and one of three dose levels of ZT-01 in a crossover design |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | July 28, 2023 |
| Estimated Primary Completion Date : | June 2025 |
| Estimated Study Completion Date : | July 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: ZT-01 7 mg
Participants receive placebo and ZT-01 7 mg each by subcutaneous injection daily for 28 days, randomized to order
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Drug: Placebo
Subject receives Placebo by subcutaneous injection daily for 28 days Drug: ZT-01, 7 mg Subject receives ZT-01 7 mg by subcutaneous injection daily for 28 days |
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Experimental: ZT-01 15 mg
Participants receive placebo and ZT-01 15 mg by subcutaneous injection daily for 28 days, randomized to order
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Drug: Placebo
Subject receives Placebo by subcutaneous injection daily for 28 days Drug: ZT-01, 15 mg Subject receives ZT-01 15 mg by subcutaneous injection daily for 28 days |
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Experimental: ZT-01 22 mg
Participants receive placebo and ZT-01 22 mg by subcutaneous injection daily for 28 days, randomized to order
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Drug: Placebo
Subject receives Placebo by subcutaneous injection daily for 28 days Drug: ZT-01, 22 mg Subject receives ZT-01 22 mg by subcutaneous injection daily for 28 days |
- Incidence of nocturnal hypoglycemia [ Time Frame: During 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
- Incidence and severity of adverse events (AEs) [ Time Frame: During each 28 day treatment period and 2-week followup ]Number of patients experiencing AEs compared to placebo
- Glucose time below range [ Time Frame: During each 28 day treatment period ]Glucose time below 54 mg/dL (as %) compared to placebo
- Incidence of hypoglycemia [ Time Frame: During each 28 day treatment period ]Number of hypoglycemic events (glucose <70 mg/dL for at least 15 minutes, compared to placebo
- Glucose time in range [ Time Frame: During each 28-day treatment period ]Glucose time in range (70-180 mg/dL, %) compared to placebo
- Mean glycemic variability [ Time Frame: During each 28 day treatment period ]Percent coefficient of variation of glucose values compared to placebo
- Mean glucose concentration [ Time Frame: During each 28 day treatment period ]Mean glucose concentration compared to placebo
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Has type 1 diabetes for at least 5 years
- Has history of recent nocturnal hypoglycemia (if using personal CGM, 4 events <54 mg/dL over previous 4 weeks at screening; if not using personal CGM then recent history of nocturnal symptomatic hypoglycemia at screening and 4 events 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:
- Currently uses automated insulin delivery system, eg closed loop or artificial pancreas
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05762107
| United States, California | |
| USC Keck Medicine Eastside Center for Diabetes | Recruiting |
| Los Angeles, California, United States, 90022 | |
| Contact: Valerie Ruelas 323-361-8416 vruelas@med.usc.edu | |
| Principal Investigator: Anne Peters, MD | |
| United States, Florida | |
| East Coast Institute for Research LLC | Recruiting |
| Jacksonville, Florida, United States, 32216 | |
| Contact: Stephanie Niman 904-740-4107 stephanie.niman@eastcoastresearch.com | |
| Principal Investigator: Wasim Deeb, MD | |
| Metabolic Research Institute | Recruiting |
| West Palm Beach, Florida, United States, 33401 | |
| Contact: Alayzah Garcia, BS 516-802-3060 ext 8032 agarcia@metabolic-institute.com | |
| Principal Investigator: Barry Horowitz, MD | |
| United States, Georgia | |
| East Coast Institute for Research | Recruiting |
| Macon, Georgia, United States, 31210 | |
| Contact: Lindsay Alexander 478-219-2017 lindsay.alexander@eastcoastresearch.com | |
| Principal Investigator: Thomas Jones, MD | |
| United States, Nevada | |
| Palm Research Center, Inc. | Recruiting |
| Las Vegas, Nevada, United States, 89148 | |
| Contact: Ellen Neylon 702-736-5161 studynurse@palmresearch.com | |
| Principal Investigator: Samer Nakhle, MD | |
| United States, North Carolina | |
| Lucas Research Inc. | Recruiting |
| Morehead City, North Carolina, United States, 28557 | |
| Contact: Mari Dunn 252-222-5700 ext 161 mari.dunn@lucasresearch.com | |
| Principal Investigator: Kathryn J Lucas, MD | |
| United States, Texas | |
| Texas Diabetes & Endocrinology, PA | Recruiting |
| Austin, Texas, United States, 78749 | |
| Contact: Cory Fields 512-334-3505 cfields@texasdiabetes.com | |
| Principal Investigator: Jean Chen, MD | |
| Diabetes & Glandular Disease Clinic | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Terri Ryan 210-614-8612 ext 1630 terri.ryan@dgdclinic.com | |
| Principal Investigator: Mark Kipnes, MD | |
| Endeavor Clinical Trials LLC | Recruiting |
| San Antonio, Texas, United States, 78240 | |
| Contact: Devin Ramirez-Escobedo 210-865-6045 DRamirez-Escobedo@ergclinical.com | |
| Principal Investigator: Emanuel P DeNoia, MD | |
| Canada, Alberta | |
| Centricity Research Calgary Endocrinology | Recruiting |
| Calgary, Alberta, Canada, T2H 2G4 | |
| Contact: Buki Ajala, MBBS 403 288 3224 ajalaresearch@centricityresearch.com | |
| Principal Investigator: Buki Ajala, MBBS | |
| Canada, British Columbia | |
| BC Diabetes | Recruiting |
| Vancouver, British Columbia, Canada, V5Y 3W2 | |
| Contact: Alireza Moshiri (604) 628-7253 amoshiri@bcdiabetes.ca | |
| Principal Investigator: Thomas Elliott, MBBS | |
| Canada, Ontario | |
| Centricity Research Barrie Endocrinology | Recruiting |
| Barrie, Ontario, Canada, L4N 7L3 | |
| Contact: Laleh Vaziri (705) 737-0830 laleh.vaziri@centricityresearch.com | |
| Principal Investigator: Hani Alasaad, MBBS | |
| Centricity Research Vaughan Endocrinology | Recruiting |
| Concord, Ontario, Canada, L4K 4M2 | |
| Contact: Barani Kumarasamy (905) 763-8660 barani.kumarasamy@centricityresearch.com | |
| Principal Investigator: Robert Schlosser, MD | |
| Centricity Research Etobicoke Endocrinology | Recruiting |
| Etobicoke, Ontario, Canada, M9R 4E1 | |
| Contact: Sneha Sharma (416) 645-1035 sneha.sharma@centricityresearch.com | |
| Principal Investigator: Hasnain Khandwala, MBBS | |
| Centricity Research Toronto | Recruiting |
| Toronto, Ontario, Canada, M4G 3E8 | |
| Contact: Nishchal Salian (416) 645-2929 nishchal.salian@centricityresearch.com | |
| Principal Investigator: Alexander Abitbol, MDCM | |
| Responsible Party: | Zucara Therapeutics Inc. |
| ClinicalTrials.gov Identifier: | NCT05762107 |
| Other Study ID Numbers: |
ZT01-CL-2001 |
| First Posted: | March 9, 2023 Key Record Dates |
| Last Update Posted: | April 11, 2024 |
| Last Verified: | April 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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nocturnal hypoglycemia |
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Diabetes Mellitus Diabetes Mellitus, Type 1 Hypoglycemia Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |