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NCT05762107RECRUITINGIRB Ready

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

(ZONE)

Sponsored by Zucara Therapeutics Inc.

Quick Self-Assessment

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๐Ÿ“Š
1 of 186 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

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

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

186 participants

๐ŸŽ‚

Age Range

18 Years - 75 Years

โšง

Gender

ALL

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Sponsor

Zucara Therapeutics Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Escondido

California

Location available
View Escondido location page
RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
TERMINATED

San Carlos

California

Location available
View San Carlos location page
RECRUITING

Jacksonville

Florida

Location available
View Jacksonville location page
RECRUITING

New Port Richey

Florida

Location available
View New Port Richey location page
RECRUITING

Port Charlotte

Florida

Location available
View Port Charlotte location page
RECRUITING

West Palm Beach

Florida

Location available
View West Palm Beach location page
RECRUITING

Atlanta

Georgia

Location available
View Atlanta location page
RECRUITING

Lawrenceville

Georgia

Location available
View Lawrenceville location page

๐Ÿ“ And 17 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Type 1 Diabetes Treatment in Escondido?

Join others in California exploring innovative treatment options through clinical research

Type 1 Diabetes Treatment Options in Escondido, California

If you're searching for Type 1 Diabetes treatment in Escondido, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Escondido, Los Angeles, San Carlos and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Type 1 Diabetes. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 186 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Type 1 Diabetes?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Type 1 Diabetes

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Type 1 Diabetes Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05762107. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.