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Type 1 Diabetes Mellitus With HypoglycemiaPhase 2ZONENCT05762107

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

A Phase 2 study testing ZT-01, 7 mg, ZT-01, 15 mg and ZT-01, 22 mg in people with Type 1 Diabetes Mellitus With Hypoglycemia, run by Zucara Therapeutics Inc. at 46 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
ZT-01, 7 mg, ZT-01, 15 mg and ZT-01, 22 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
186 participants
Where
46 sitesin 2 countries
Study dates
28 Jul 2023to May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

46 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

46 sites in 2 countries

United States38 sites, 37 recruiting

  • Albany Medical Center

    Albany, New York, 12203

    Judy Carter, 518-264-4723, carterj3@amc.edu

    Gregg Gerety, MD

    Recruiting

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 21044

    Amanda Maxson, 404-355-4393, studyadmin@atlantadiabetes.com

    Bruce Bode, MD

    Recruiting

  • Barbara Davis Center for Diabetes

    Aurora, Colorado, 80045

    Emma Mason, 3037245895, emma.mason@cuanschutz.edu

    Halis Akturk, MD

    Recruiting

  • Texas Diabetes & Endocrinology, PA

    Austin, Texas, 78749

    Cory Fields, 512-334-3505, cfields@texasdiabetes.com

    Jean Chen, MD

    Recruiting

  • Baltimore VA Medical Center

    Baltimore, Maryland, 21201

    William Scott, 410-605-7000, william.scott5@va.gov

    Ilias Spanakis, MD

    Recruiting

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239

    Lumanti Manandhar, 443-444-4858, Lumanti.Manandhar@medstar.net

    Jean Park, MD

    Recruiting

  • Kirklin Clinic of UAB Hospital-Endocrinology/Diabetes Clinic

    Birmingham, Alabama, 35233

    Julia Parker, 4126487183, juliaparker@uabmc.edu

    Fernando Ovalle, MD

    Recruiting

  • University Diabetes & Endocrine Consultants

    Chattanooga, Tennessee, 37411

    Jason Hughes-Palmer, 426-265-3561, jhughes-palmer@drhuffman.com

    David Huffman, MD

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Triniece Pearson, 7733597556, tpearson1@bsd.uchicago.edu

    Louis Philipson, MD

    Recruiting

  • Ohio State University Wexner Medical Center

    Columbia, Ohio, 43210

    Maryam Bhatti, 6148140821, maryam.bhatti@osumc.edu

    Kathleen Wyne, MD

    Recruiting

  • North Texas Endocrine Center

    Dallas, Texas, 75231

    Michelle Katz, 469-364-6918, mkatz@endocenter.com

    Peter Bressler, MD

    Recruiting

  • Headlands Research

    Escondido, California, 92025

    Yvonne Bedolla, 760-466-1537, yvonne.bedolla@headlandsresearchamcr.com

    Timothy Bailey, MD

    Recruiting

  • Elite Research Center

    Flint, Michigan, 48532

    Wafaa Hammoud, 810-820-9853, wh@researcherc.com

    Jamal Hammoud, MD

    Recruiting

  • IU Health University Hospital

    Indianapolis, Indiana, 46202

    Kathy Bohanan, 317-278-0651, kkremer@iu.edu

    Viral Shah, MD

    Recruiting

  • East Coast Institute for Research LLC

    Jacksonville, Florida, 32216

    Stephanie Niman, 904-740-4107, stephanie.niman@eastcoastresearch.com

    Wasim Deeb, MD

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Frieda Tresvan, 913-588-2607, ftresvan@kumc.edu

    Chitra Choudhary, MD

    Recruiting

  • Palm Research Center, Inc.

    Las Vegas, Nevada, 89148

    Ellen Neylon, 702-736-5161, studynurse@palmresearch.com

    Samer Nakhle, MD

    Recruiting

  • Physicians Research Associates LLC

    Lawrenceville, Georgia, 30046

    Karla Wardell, 678-252-2375, karlaw@northatlantaendo.com

    Adeniyi Odugbesan, MD

    Recruiting

  • Medical Investigations Indications Inc.

    Little Rock, Arkansas, 72211

    Lesa Thrasher, 5018314087, lesathrasher@yahoo.com

    James Thrasher, MD

    Recruiting

  • NYC Research Inc.

    Long Island City, New York, 11106

    John Bell, 718-704-5376, jbell@endocrinenyc.com

    Anastasios Manessis, MD

    Recruiting

  • USC Keck Medicine Eastside Center for Diabetes

    Los Angeles, California, 90022

    Valerie Ruelas, (323) 361-8416, vruelas@med.usc.edu

    Anne Peters, MD

    Recruiting

  • East Coast Institute for Research

    Macon, Georgia, 31210

    Lilly Dasher Anthony, 478-219-2017, lilly.dasher@eastcoastresearch.net

    Thomas Jones, MD

    Recruiting

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149

    Michelle Ormeno, 214-693-0904, mormeno@southerenendocrinology.com

    Sumana Gangi, MD

    Recruiting

  • Lucas Research Inc.

    Morehead City, North Carolina, 28557

    Mari Dunn, 252-222-5700 ext. 161, mari.dunn@lucasresearch.com

    Kathryn J Lucas, MD

    Recruiting

  • Yale University - Diabetes Research Office

    New Haven, Connecticut, 06511

    Amy Steffen, 2037378852, amy.steffen@yale.edu

    Laura Nally, MD

    Recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

    Teva Williams, 5047030922, teva.williams@ochsner.org

    Lawrence Blonde, MD

    Recruiting

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

    Jasmine Dodson, 727-855-7103, jasmine.dodson@atlas-clinical.com

    Antonio Pinero Pilona, MD

    Recruiting

  • NYU Langone Health CTSI

    New York, New York, 10016

    Amanda Baly, 212-263-1432, Amanda.Baly@nyulangone.org

    Ramachandra Naik, MD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Susan Burbach, 4025594228, susan.burbach@unmc.edu

    Shubham Agarwal, MD

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Marsha Simmons, 215-955-1925, Marsha.Simmons@jefferson.edu

    Serge Jabbour, MD

    Recruiting

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

    Wanda Ferrara, 4126487183, ferrarawa@upmc.edu

    Jagdeesh Ullal, MD

    Recruiting

  • Hanson Diabetes Center

    Port Charlotte, Florida, 33952

    Lenita Hanson, MD, 941-654-4800, lhansonmd@hansoncrc.com

    Lenita Hanson, MD

    Recruiting

  • Diabetes & Glandular Disease Clinic

    San Antonio, Texas, 78229

    Terri Ryan, 210-614-8612 ext. 1630, terri.ryan@dgdclinic.com

    Mark Kipnes, MD

    Recruiting

  • LCGK Research

    San Carlos, California, 94070

    Terminated

  • Diabetes & Endocrine Treatment Specialists

    Sandy City, Utah, 84093

    Ryan Luker, 801-816-1010, ryan@detsutah.com

    Timothy Graham, MD

    Recruiting

  • University of Washington Diabetes Institute - Clinical Research Unit

    Seattle, Washington, 98109

    Caelan Ruiz, 2066166858, ccr20@uw.edu

    Subbulaxmi Trikudanathan, MD

    Recruiting

  • University of South Florida Diabetes & Endocrinology Clinic

    Tampa, Florida, 33612

    Chloe Lee, 8139745499, chloelee@usf.edu

    Henry Rodriguez, MD

    Recruiting

  • Metabolic Research Institute

    West Palm Beach, Florida, 33401

    Cossett Allegue, 561-802-3060, callegue@metabolic-institute.com

    Barry Horowitz, MD

    Recruiting

Other trials in United States

Canada8 sites, 7 recruiting

  • Centricity Research Barrie Endocrinology

    Barrie, Ontario, L4N 7L3

    Withdrawn

  • Centricity Research Calgary Endocrinology

    Calgary, Alberta, T2H 2G4

    Buki Ajala, MBBS, 403-288-3224, ajalaresearch@centricityresearch.com

    Buki Ajala, MBBS

    Recruiting

  • Richmond Road Diagnostic & Treatment Centre, Clinical Trials Unit

    Calgary, Alberta, T2T5C7

    Michelle Smith, 4039558117, mahunter@ucalgary.ca

    Ronald Sigal, MD

    Recruiting

  • Centricity Research Vaughan Endocrinology

    Concord, Ontario, L4K 4M2

    Sanjida Nishat, 905-288-5667 ext. 4296, sanjida.nishat@centricityresearch.com

    Robert Schlosser, MD

    Recruiting

  • Centricity Research Etobicoke Endocrinology

    Etobicoke, Ontario, M9R 4E1

    Sneha Sharma, 416-645-1035, sneha.sharma@centricityresearch.com

    Hasnain Khandwala, MBBS

    Recruiting

  • Centricity Research Toronto

    Toronto, Ontario, M4G 3E8

    Janessa Gabuyo, 647-374-5285, janessa.gabuyo@centricityresearch.com

    Alexander Abitbol, MDCM

    Recruiting

  • Mount Sinai Hospital: Leadership Sinai Centre for Diabetes

    Toronto, Ontario, M5T 3L9

    Andrej Orszag, 416-586-4800 ext. 7625, andrej.orszag@uhn.ca

    Bruce Perkins, MD

    Recruiting

  • BC Diabetes

    Vancouver, British Columbia, V5Y 3W2

    Alireza Moshiri, 604-628-7253, amoshiri@bcdiabetes.ca

    Thomas Elliott, MBBS

    Recruiting

Other trials in Canada

About this study

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

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.

Read more

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).

Being tested
Placebo, ZT-01, 7 mg, ZT-01, 15 mg, ZT-01, 22 mg
Keywords
nocturnal hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Subject receives Placebo by subcutaneous injection daily for 28 days

  • ZT-01, 7 mgDrug

    Subject receives ZT-01 7 mg by subcutaneous injection daily for 28 days

  • ZT-01, 15 mgDrug

    Subject receives ZT-01 15 mg by subcutaneous injection daily for 28 days

  • ZT-01, 22 mgDrug

    Subject receives ZT-01 22 mg by subcutaneous injection daily for 28 days

Study groups in NCT05762107
Study groupRoleWhat they receive
ZT-01 7 mgExperimentalParticipants receive placebo and ZT-01 7 mg each by subcutaneous injection daily for 28 days, randomized to order
Receives: Drug: Placebo; Drug: ZT-01, 7 mg
ZT-01 15 mgExperimentalParticipants receive placebo and ZT-01 15 mg by subcutaneous injection daily for 28 days, randomized to order
Receives: Drug: Placebo; Drug: ZT-01, 15 mg
ZT-01 22 mgExperimentalParticipants receive placebo and ZT-01 22 mg by subcutaneous injection daily for 28 days, randomized to order
Receives: Drug: Placebo; Drug: ZT-01, 22 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of nocturnal hypoglycemia

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

    Measured: During each 28 day treatment period

Secondary outcomes (3)

  1. Incidence and severity of adverse events (AEs)

    Number of patients experiencing AEs compared to placebo

    Measured: During each 28 day treatment period and 2-week followup

  2. Glucose time below range

    Glucose time below 54 mg/dL (as %) compared to placebo

    Measured: During each 28 day treatment period

  3. Incidence of hypoglycemia

    Number of hypoglycemic events (glucose <70 mg/dL for at least 15 minutes, compared to placebo

    Measured: During each 28 day treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2023
  2. Study start28 Jul 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05762107
Sponsor's protocol ID
ZT01-CL-2001
Acronym
ZONE
Status last verified
Apr 2026
First submitted
27 Feb 2023
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZT-01, 7 mg, ZT-01, 15 mg and ZT-01, 22 mg in people with Type 1 Diabetes Mellitus With Hypoglycemia, run by Zucara Therapeutics Inc. at 46 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of nocturnal hypoglycemia (time frame: During each 28 day treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05762107.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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