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RecruitingPhase 2

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

Zucara Therapeutics Inc. · NCT05762107

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
186
US sites recruiting
37
Study start
July 28, 2023
Record last updated
April 29, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Placebo; ZT-01, 7 mg; ZT-01, 15 mg; ZT-01, 22 mg

Conditions: Type 1 Diabetes Mellitus With Hypoglycemia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Kirklin Clinic of UAB Hospital-Endocrinology/Diabetes Clinic

    Birmingham, AL 35233

    Site contact: Julia Parker · 4126487183 · juliaparker@uabmc.edu

  • Medical Investigations Indications Inc.

    Little Rock, AR 72211

    Site contact: Lesa Thrasher · 5018314087 · lesathrasher@yahoo.com

  • Headlands Research

    Escondido, CA 92025

    Site contact: Yvonne Bedolla · 760-466-1537 · yvonne.bedolla@headlandsresearchamcr.com

  • USC Keck Medicine Eastside Center for Diabetes

    Los Angeles, CA 90022

    Site contact: Valerie Ruelas · (323) 361-8416 · vruelas@med.usc.edu

  • Barbara Davis Center for Diabetes

    Aurora, CO 80045

    Site contact: Emma Mason · 3037245895 · emma.mason@cuanschutz.edu

  • Yale University - Diabetes Research Office

    New Haven, CT 06511

    Site contact: Amy Steffen · 2037378852 · amy.steffen@yale.edu

  • East Coast Institute for Research LLC

    Jacksonville, FL 32216

    Site contact: Stephanie Niman · 904-740-4107 · stephanie.niman@eastcoastresearch.com

  • Suncoast Clinical Research

    New Port Richey, FL 34652

    Site contact: Jasmine Dodson · 727-855-7103 · jasmine.dodson@atlas-clinical.com

  • Hanson Diabetes Center

    Port Charlotte, FL 33952

    Site contact: Lenita Hanson, MD · 941-654-4800 · lhansonmd@hansoncrc.com

  • University of South Florida Diabetes & Endocrinology Clinic

    Tampa, FL 33612

    Site contact: Chloe Lee · 8139745499 · chloelee@usf.edu

  • Metabolic Research Institute

    West Palm Beach, FL 33401

    Site contact: Cossett Allegue · 561-802-3060 · callegue@metabolic-institute.com

  • Atlanta Diabetes Associates

    Atlanta, GA 21044

    Site contact: Amanda Maxson · 404-355-4393 · studyadmin@atlantadiabetes.com

  • Physicians Research Associates LLC

    Lawrenceville, GA 30046

    Site contact: Karla Wardell · 678-252-2375 · karlaw@northatlantaendo.com

  • East Coast Institute for Research

    Macon, GA 31210

    Site contact: Lilly Dasher Anthony · 478-219-2017 · lilly.dasher@eastcoastresearch.net

  • University of Chicago Medical Center

    Chicago, IL 60637

    Site contact: Triniece Pearson · 7733597556 · tpearson1@bsd.uchicago.edu

  • IU Health University Hospital

    Indianapolis, IN 46202

    Site contact: Kathy Bohanan · 317-278-0651 · kkremer@iu.edu

  • University of Kansas Medical Center

    Kansas City, KS 66160

    Site contact: Frieda Tresvan · 913-588-2607 · ftresvan@kumc.edu

  • Ochsner Clinic Foundation

    New Orleans, LA 70121

    Site contact: Teva Williams · 5047030922 · teva.williams@ochsner.org

  • Baltimore VA Medical Center

    Baltimore, MD 21201

    Site contact: William Scott · 410-605-7000 · william.scott5@va.gov

  • MedStar Good Samaritan Hospital

    Baltimore, MD 21239

    Site contact: Lumanti Manandhar · 443-444-4858 · Lumanti.Manandhar@medstar.net

  • Elite Research Center

    Flint, MI 48532

    Site contact: Wafaa Hammoud · 810-820-9853 · wh@researcherc.com

  • University of Nebraska Medical Center

    Omaha, NE 68198

    Site contact: Susan Burbach · 4025594228 · susan.burbach@unmc.edu

  • Palm Research Center, Inc.

    Las Vegas, NV 89148

    Site contact: Ellen Neylon · 702-736-5161 · studynurse@palmresearch.com

  • Albany Medical Center

    Albany, NY 12203

    Site contact: Judy Carter · 518-264-4723 · carterj3@amc.edu

  • NYC Research Inc.

    Long Island City, NY 11106

    Site contact: John Bell · 718-704-5376 · jbell@endocrinenyc.com

  • NYU Langone Health CTSI

    New York, NY 10016

    Site contact: Amanda Baly · 212-263-1432 · Amanda.Baly@nyulangone.org

  • Lucas Research Inc.

    Morehead City, NC 28557

    Site contact: Mari Dunn · 252-222-5700 · mari.dunn@lucasresearch.com

  • Ohio State University Wexner Medical Center

    Columbia, OH 43210

    Site contact: Maryam Bhatti · 6148140821 · maryam.bhatti@osumc.edu

  • Thomas Jefferson University

    Philadelphia, PA 19107

    Site contact: Marsha Simmons · 215-955-1925 · Marsha.Simmons@jefferson.edu

  • UPMC Presbyterian Hospital

    Pittsburgh, PA 15213

    Site contact: Wanda Ferrara · 4126487183 · ferrarawa@upmc.edu

  • University Diabetes & Endocrine Consultants

    Chattanooga, TN 37411

    Site contact: Jason Hughes-Palmer · 426-265-3561 · jhughes-palmer@drhuffman.com

  • Texas Diabetes & Endocrinology, PA

    Austin, TX 78749

    Site contact: Cory Fields · 512-334-3505 · cfields@texasdiabetes.com

  • North Texas Endocrine Center

    Dallas, TX 75231

    Site contact: Michelle Katz · 469-364-6918 · mkatz@endocenter.com

  • Southern Endocrinology Associates

    Mesquite, TX 75149

    Site contact: Michelle Ormeno · 214-693-0904 · mormeno@southerenendocrinology.com

  • Diabetes & Glandular Disease Clinic

    San Antonio, TX 78229

    Site contact: Terri Ryan · 210-614-8612 · terri.ryan@dgdclinic.com

  • Diabetes & Endocrine Treatment Specialists

    Sandy City, UT 84093

    Site contact: Ryan Luker · 801-816-1010 · ryan@detsutah.com

  • University of Washington Diabetes Institute - Clinical Research Unit

    Seattle, WA 98109

    Site contact: Caelan Ruiz · 2066166858 · ccr20@uw.edu

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A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type… (NCT05762107) | Bored Studies