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

NCT05762107 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ZT01-CL-2001
• Study Type: interventional
• Target: 186
• Locations: 2 countries
• Sites: 46

Brief 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. 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).

Conditions

Type 1 Diabetes Mellitus With Hypoglycemia

Keywords

nocturnal hypoglycemia

Outcome Measures

Primary Outcomes (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

  During each 28 day treatment period

Secondary Outcomes (3)

• Incidence and severity of adverse events (AEs)

  During each 28 day treatment period and 2-week followup

• Glucose time below range

  During each 28 day treatment period

• Incidence of hypoglycemia

  During each 28 day treatment period

Other Outcomes (3)

• Glucose time in range

  During each 28-day treatment period

• Mean glycemic variability

  During each 28 day treatment period

• Mean glucose concentration

  During each 28 day treatment period

Study Arms (3)

ZT-01 7 mg

EXPERIMENTAL

Participants receive placebo and ZT-01 7 mg each by subcutaneous injection daily for 28 days, randomized to order

Drug: Placebo; Drug: ZT-01, 7 mg

ZT-01 15 mg

EXPERIMENTAL

Participants receive placebo and ZT-01 15 mg by subcutaneous injection daily for 28 days, randomized to order

Drug: Placebo; Drug: ZT-01, 15 mg

ZT-01 22 mg

EXPERIMENTAL

Participants receive placebo and ZT-01 22 mg by subcutaneous injection daily for 28 days, randomized to order

Drug: Placebo; Drug: ZT-01, 22 mg

Interventions

Placebo DRUG

Subject receives Placebo by subcutaneous injection daily for 28 days

ZT-01 15 mg; ZT-01 22 mg; ZT-01 7 mg

ZT-01, 7 mg DRUG

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

ZT-01 7 mg

ZT-01, 15 mg DRUG

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

ZT-01 15 mg

ZT-01, 22 mg DRUG

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

ZT-01 22 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zucara Therapeutics Inc.: lead

Study Sites (46)

Kirklin Clinic of UAB Hospital-Endocrinology/Diabetes Clinic

Birmingham, Alabama, 35233, United States

RECRUITING

Medical Investigations Indications Inc.

Little Rock, Arkansas, 72211, United States

RECRUITING

Headlands Research

Escondido, California, 92025, United States

RECRUITING

USC Keck Medicine Eastside Center for Diabetes

Los Angeles, California, 90022, United States

RECRUITING

LCGK Research

San Carlos, California, 94070, United States

TERMINATED

Barbara Davis Center for Diabetes

Aurora, Colorado, 80045, United States

RECRUITING

Yale University - Diabetes Research Office

New Haven, Connecticut, 06511, United States

RECRUITING

East Coast Institute for Research LLC

Jacksonville, Florida, 32216, United States

RECRUITING

Suncoast Clinical Research

New Port Richey, Florida, 34652, United States

RECRUITING

Hanson Diabetes Center

Port Charlotte, Florida, 33952, United States

RECRUITING

University of South Florida Diabetes & Endocrinology Clinic

Tampa, Florida, 33612, United States

RECRUITING

Metabolic Research Institute

West Palm Beach, Florida, 33401, United States

RECRUITING

Atlanta Diabetes Associates

Atlanta, Georgia, 21044, United States

RECRUITING

Physicians Research Associates LLC

Lawrenceville, Georgia, 30046, United States

RECRUITING

East Coast Institute for Research

Macon, Georgia, 31210, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

RECRUITING

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

MedStar Good Samaritan Hospital

Baltimore, Maryland, 21239, United States

RECRUITING

Elite Research Center

Flint, Michigan, 48532, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Palm Research Center, Inc.

Las Vegas, Nevada, 89148, United States

RECRUITING

Albany Medical Center

Albany, New York, 12203, United States

RECRUITING

NYC Research Inc.

Long Island City, New York, 11106, United States

RECRUITING

NYU Langone Health CTSI

New York, New York, 10016, United States

RECRUITING

Lucas Research Inc.

Morehead City, North Carolina, 28557, United States

RECRUITING

Ohio State University Wexner Medical Center

Columbia, Ohio, 43210, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

RECRUITING

Texas Diabetes & Endocrinology, PA

Austin, Texas, 78749, United States

RECRUITING

North Texas Endocrine Center

Dallas, Texas, 75231, United States

RECRUITING

Southern Endocrinology Associates

Mesquite, Texas, 75149, United States

RECRUITING

Diabetes & Glandular Disease Clinic

San Antonio, Texas, 78229, United States

RECRUITING

Diabetes & Endocrine Treatment Specialists

Sandy City, Utah, 84093, United States

RECRUITING

University of Washington Diabetes Institute - Clinical Research Unit

Seattle, Washington, 98109, United States

RECRUITING

Centricity Research Calgary Endocrinology

Calgary, Alberta, T2H 2G4, Canada

RECRUITING

Richmond Road Diagnostic & Treatment Centre, Clinical Trials Unit

Calgary, Alberta, T2T5C7, Canada

RECRUITING

BC Diabetes

Vancouver, British Columbia, V5Y 3W2, Canada

RECRUITING

Centricity Research Barrie Endocrinology

Barrie, Ontario, L4N 7L3, Canada

WITHDRAWN

Centricity Research Vaughan Endocrinology

Concord, Ontario, L4K 4M2, Canada

RECRUITING

Centricity Research Etobicoke Endocrinology

Etobicoke, Ontario, M9R 4E1, Canada

RECRUITING

Centricity Research Toronto

Toronto, Ontario, M4G 3E8, Canada

RECRUITING

Mount Sinai Hospital: Leadership Sinai Centre for Diabetes

Toronto, Ontario, M5T 3L9, Canada

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The participant will be randomized to receive placebo and one of three dose levels of ZT-01 in a crossover design

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: July 28, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (38); CA (8)