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Hormone Therapy

ZT-01 for Type 1 Diabetes (ZONE Trial)

Q: Has the FDA sanctioned ZT-01 7 mg for public consumption?

Our team's assessment of the safety profile for ZT-01 7 mg is a 2, as this Phase 2 trial has only collected data on its safety and not yet established efficacy.

Q: Is the research study accepting elderly individuals as participants?

According to the criteria, this trial is available for individuals aged 18-75. Additionally, there are 219 clinical trials specifically targeting minors and 971 studies designed for those over 65 years of age.

Q: What criteria must individuals meet to be eligible for this research program?

This research needs 168 participants with a diagnosis of diabetes mellitus, aged between 18 and 75. Aspiring recruits are expected to meet the following qualifications: having <a href="https://www.withpower.com/clinical-trials/type-1-diabetes">type 1 diabetes</a> for at least 5 years; recent nocturnal hypoglycemia (as evidenced by either personal CGM data or symptomatic episodes); HbA1c level below 10%; BMI within the range of 18.5-33 kg/m2.

Q: What is the aggregate population size for this clinical experiment?

Indeed, the details on clinicaltrials.gov reveal that this experiment is actively seeking volunteers to participate; it was first posted on July 28th 2023 and updated most recently on August 9th of the same year. The trial requires 168 people across 3 centers for data collection.

Q: Is enrollment available for this clinical experiment at the present time?

Clinicaltrials.gov shows that this trial is currently enrolling participants, with the first posting on July 28th 2023 and most recent update taking place August 9th 2023.

Phase 2

Recruiting

Research Sponsored by Zucara Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has type 1 diabetes for at least 5 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during each 28 day treatment period and 2-week followup

Awards & highlights

ZONE Trial Summary

This trial studies the effects of ZT-01 to reduce low blood sugar in adults with type 1 diabetes. Participants will use ZT-01 and placebo and wear a CGM, and have tests and questionnaires at 6 visits. Some participants will take part in a sub-study with 4 overnight stays.

Who is the study for?

Adults with type 1 diabetes who have had the condition for at least 5 years and experience low blood sugar at night. They must have an HbA1c level of 10% or less, a BMI between 18.5 to <33 kg/m^2, and no severe hypoglycemia or hospitalizations for diabetic ketoacidosis recently. People with abnormal liver function, significant kidney disease, other specific health conditions, or using automated insulin delivery systems cannot participate.Check my eligibility

What is being tested?

The trial is testing ZT-01's ability to prevent nighttime low blood sugar in people with type 1 diabetes by increasing glucagon levels. Participants will self-inject either ZT-01 at varying doses or a placebo before bed while wearing a glucose monitor over two separate periods without knowing which they're receiving.See study design

What are the potential side effects?

Potential side effects are not detailed here but may include reactions related to hormone changes due to increased glucagon levels from ZT-01 injections. Blood pressure, temperature checks, ECG readings and lab tests (blood/urine) will help monitor safety throughout the study.

ZONE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had type 1 diabetes for 5 years or more.

ZONE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during each 28 day treatment period and 2-week followup

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during each 28 day treatment period and 2-week followup

This trial's timeline: 3 weeks for screening, Varies for treatment, and during each 28 day treatment period and 2-week followup for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of nocturnal hypoglycemia

Secondary outcome measures

Glucose time below range

Incidence and severity of adverse events (AEs)

Incidence of hypoglycemia

Other outcome measures

Glucose time in range

Mean glucose concentration

Mean glycemic variability

ZONE Trial Design

3Treatment groups

Experimental Treatment

Group I: ZT-01 7 mgExperimental Treatment2 Interventions

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

Group II: ZT-01 22 mgExperimental Treatment2 Interventions

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

Group III: ZT-01 15 mgExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zucara Therapeutics Inc.Lead Sponsor

1 Previous Clinical Trials

24 Total Patients Enrolled

1 Trials studying Diabetes Mellitus

24 Patients Enrolled for Diabetes Mellitus

Media Library

ZT-01 (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05762107 — Phase 2

Diabetes Mellitus Research Study Groups: ZT-01 7 mg, ZT-01 15 mg, ZT-01 22 mg

Diabetes Mellitus Clinical Trial 2023: ZT-01 Highlights & Side Effects. Trial Name: NCT05762107 — Phase 2

ZT-01 (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05762107 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned ZT-01 7 mg for public consumption?

"Our team's assessment of the safety profile for ZT-01 7 mg is a 2, as this Phase 2 trial has only collected data on its safety and not yet established efficacy."

Answered by AI

Is the research study accepting elderly individuals as participants?

"According to the criteria, this trial is available for individuals aged 18-75. Additionally, there are 219 clinical trials specifically targeting minors and 971 studies designed for those over 65 years of age."

Answered by AI

What criteria must individuals meet to be eligible for this research program?

"This research needs 168 participants with a diagnosis of diabetes mellitus, aged between 18 and 75. Aspiring recruits are expected to meet the following qualifications: having type 1 diabetes for at least 5 years; recent nocturnal hypoglycemia (as evidenced by either personal CGM data or symptomatic episodes); HbA1c level below 10%; BMI within the range of 18.5-33 kg/m2."

Answered by AI

What is the aggregate population size for this clinical experiment?

"Indeed, the details on clinicaltrials.gov reveal that this experiment is actively seeking volunteers to participate; it was first posted on July 28th 2023 and updated most recently on August 9th of the same year. The trial requires 168 people across 3 centers for data collection."

Answered by AI

Is enrollment available for this clinical experiment at the present time?

"Clinicaltrials.gov shows that this trial is currently enrolling participants, with the first posting on July 28th 2023 and most recent update taking place August 9th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05762107.

All > Hypoglycemia