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

April 23, 2026 updated by: Zucara Therapeutics Inc.

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.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

186

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2H 2G4
        • Recruiting
        • Centricity Research Calgary Endocrinology
        • Principal Investigator:
          • Buki Ajala, MBBS
        • Contact:
      • Calgary, Alberta, Canada, T2T5C7
        • Recruiting
        • Richmond Road Diagnostic & Treatment Centre, Clinical Trials Unit
        • Contact:
        • Principal Investigator:
          • Ronald Sigal, MD
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Y 3W2
        • Recruiting
        • BC Diabetes
        • Principal Investigator:
          • Thomas Elliott, MBBS
        • Contact:
    • Ontario
      • Barrie, Ontario, Canada, L4N 7L3
        • Withdrawn
        • Centricity Research Barrie Endocrinology
      • Concord, Ontario, Canada, L4K 4M2
        • Recruiting
        • Centricity Research Vaughan Endocrinology
        • Principal Investigator:
          • Robert Schlosser, MD
        • Contact:
      • Etobicoke, Ontario, Canada, M9R 4E1
        • Recruiting
        • Centricity Research Etobicoke Endocrinology
        • Principal Investigator:
          • Hasnain Khandwala, MBBS
        • Contact:
      • Toronto, Ontario, Canada, M4G 3E8
      • Toronto, Ontario, Canada, M5T 3L9
        • Recruiting
        • Mount Sinai Hospital: Leadership Sinai Centre for Diabetes
        • Contact:
        • Principal Investigator:
          • Bruce Perkins, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Kirklin Clinic of UAB Hospital-Endocrinology/Diabetes Clinic
        • Contact:
        • Principal Investigator:
          • Fernando Ovalle, MD
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Medical Investigations Indications Inc.
        • Principal Investigator:
          • James Thrasher, MD
        • Contact:
    • California
      • Escondido, California, United States, 92025
      • Los Angeles, California, United States, 90022
        • Recruiting
        • USC Keck Medicine Eastside Center for Diabetes
        • Principal Investigator:
          • Anne Peters, MD
        • Contact:
      • San Carlos, California, United States, 94070
        • Terminated
        • LCGK Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Barbara Davis Center for Diabetes
        • Principal Investigator:
          • Halis Akturk, MD
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale University - Diabetes Research Office
        • Principal Investigator:
          • Laura Nally, MD
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • East Coast Institute For Research LLC
        • Contact:
        • Principal Investigator:
          • Wasim Deeb, MD
      • New Port Richey, Florida, United States, 34652
        • Recruiting
        • Suncoast Clinical Research
        • Contact:
        • Principal Investigator:
          • Antonio Pinero Pilona, MD
      • Port Charlotte, Florida, United States, 33952
        • Recruiting
        • Hanson Diabetes Center
        • Principal Investigator:
          • Lenita Hanson, MD
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida Diabetes & Endocrinology Clinic
        • Principal Investigator:
          • Henry Rodriguez, MD
        • Contact:
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Metabolic Research Institute
        • Principal Investigator:
          • Barry Horowitz, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 21044
        • Recruiting
        • Atlanta Diabetes Associates
        • Principal Investigator:
          • Bruce Bode, MD
        • Contact:
      • Lawrenceville, Georgia, United States, 30046
        • Recruiting
        • Physicians Research Associates LLC
        • Contact:
        • Principal Investigator:
          • Adeniyi Odugbesan, MD
      • Macon, Georgia, United States, 31210
        • Recruiting
        • East Coast Institute for Research
        • Principal Investigator:
          • Thomas Jones, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center
        • Principal Investigator:
          • Louis Philipson, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • IU Health University Hospital
        • Principal Investigator:
          • Viral Shah, MD
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Chitra Choudhary, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Lawrence Blonde, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Baltimore VA Medical Center
        • Principal Investigator:
          • Ilias Spanakis, MD
        • Contact:
      • Baltimore, Maryland, United States, 21239
        • Recruiting
        • MedStar Good Samaritan Hospital
        • Principal Investigator:
          • Jean Park, MD
        • Contact:
    • Michigan
      • Flint, Michigan, United States, 48532
        • Recruiting
        • Elite Research Center
        • Principal Investigator:
          • Jamal Hammoud, MD
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Shubham Agarwal, MD
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Palm Research Center, Inc.
        • Principal Investigator:
          • Samer Nakhle, MD
        • Contact:
    • New York
      • Albany, New York, United States, 12203
        • Recruiting
        • Albany Medical Center
        • Contact:
        • Principal Investigator:
          • Gregg Gerety, MD
      • Long Island City, New York, United States, 11106
        • Recruiting
        • NYC Research Inc.
        • Principal Investigator:
          • Anastasios Manessis, MD
        • Contact:
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health CTSI
        • Contact:
        • Principal Investigator:
          • Ramachandra Naik, MD
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Lucas Research Inc.
        • Principal Investigator:
          • Kathryn J Lucas, MD
        • Contact:
    • Ohio
      • Columbia, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Wexner Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen Wyne, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Contact:
        • Principal Investigator:
          • Serge Jabbour, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Presbyterian Hospital
        • Principal Investigator:
          • Jagdeesh Ullal, MD
        • Contact:
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Recruiting
        • University Diabetes & Endocrine Consultants
        • Principal Investigator:
          • David Huffman, MD
        • Contact:
    • Texas
      • Austin, Texas, United States, 78749
        • Recruiting
        • Texas Diabetes & Endocrinology, PA
        • Contact:
        • Principal Investigator:
          • Jean Chen, MD
      • Dallas, Texas, United States, 75231
        • Recruiting
        • North Texas Endocrine Center
        • Principal Investigator:
          • Peter Bressler, MD
        • Contact:
      • Mesquite, Texas, United States, 75149
        • Recruiting
        • Southern Endocrinology Associates
        • Contact:
        • Principal Investigator:
          • Sumana Gangi, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Diabetes & Glandular Disease Clinic
        • Principal Investigator:
          • Mark Kipnes, MD
        • Contact:
    • Utah
      • Sandy City, Utah, United States, 84093
        • Recruiting
        • Diabetes & Endocrine Treatment Specialists
        • Principal Investigator:
          • Timothy Graham, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington Diabetes Institute - Clinical Research Unit
        • Principal Investigator:
          • Subbulaxmi Trikudanathan, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ZT-01 7 mg
Participants receive placebo and ZT-01 7 mg each by subcutaneous injection daily for 28 days, randomized to order
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
Experimental: ZT-01 15 mg
Participants receive placebo and ZT-01 15 mg by subcutaneous injection daily for 28 days, randomized to order
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
Experimental: ZT-01 22 mg
Participants receive placebo and ZT-01 22 mg by subcutaneous injection daily for 28 days, randomized to order
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During each 28 day treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During each 28 day treatment period and 2-week followup
Glucose time below range
Time Frame: During each 28 day treatment period
Glucose time below 54 mg/dL (as %) compared to placebo
During each 28 day treatment period
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
During each 28 day treatment period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose time in range
Time Frame: During each 28-day treatment period
Glucose time in range (70-180 mg/dL, %) compared to placebo
During each 28-day treatment period
Mean glucose concentration
Time Frame: During each 28 day treatment period
Mean glucose concentration compared to placebo
During each 28 day treatment period
Mean glycemic variability
Time Frame: During each 28 day treatment period
Percent coefficient of variation of glucose values compared to placebo
During each 28 day treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zucara Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Actual)

March 9, 2023

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZT01-CL-2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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